Is Depression Always a Disease?

Like most mental health writers, I have compareddepression to illnesses like diabetes in the past, and stressed the biochemical aspect of mood disorders in my efforts to reduce stigma. Somehow talking about the gene G72/G30 located on chromosome 13q (that may predispose individuals to depression and bipolar disorder) makes it more legitimate, as if the gene proves we aren’t making it up.

However, the more I read about how abuse, trauma, and chronic stress —unresolved issues of all kinds — can cause and aggravate depression, the less I want to compare it to diabetes.

Taking insulin really isn’t the same thing as taking an antidepressant.

It’s not that simple.

As I wrote about in my recent blog about selective serotonin reuptake inhibitor (SSRIs), the theory that depressed people suffer from a lack of serotonin and other neurotransmitters, which are replenished by antidepressants, sounds good, but isn’t totally accurate. SSRIs aren’t like insulin in that they fill in a deficiency. In fact, we still don’t really know how they work, but they certainly do for many people.

In his chapter A Heroic Passage in the book Darkness Before Dawn, psychiatrist James Gordon, MD, writes, “Depression is not a disease, the end point of a pathological process. It is a sign that our lives are out of balance, that we’re stuck. It’s a wake-up call and the start of a journey that can help us become whole and happy, a hero’s journey that can change and transform our lives.”

Part of me cringes when I read that.

Forever stuck in my brain is renowned psychiatrist Peter Kramer’s quote: “Depression is not a perspective. It is a disease. To see the worst things a person can see is one experience; to suffer a mood disorder is another.”

And yet, I agree with Dr. Gordon on some kinds of depression.

For example, the symptoms of sadness, irritability, and interrupted sleep I experienced at the beginning of this year was a wake-up call that I was working too many hours and trying too hard to build a foundation for treatment-resistant depression overnight. Crying for five days straight led to an aha moment, when I realized that my health and my family should always come first. So I backed down my work hours and delegated more tasks to other administrators in my depression community, and the sadness and panic faded. I don’t think popping a Xanax or upping my Zoloftwould have done much good.

However, there are also times when I know the depression is nothing more than a biochemical response. When I tried the natural hormone progesterone, for example, and my thoughts went from “I wish I were dead” to “Let’s review some suicidal plans immediately.” Luckily I knew my mental state was due to the progesterone because my psychiatrist had warned me about taking it (I didn’t listen), and I knew a friend who wanted to jump off the Bay Bridge after rubbing progesterone cream on her chest. I have a similar reaction when I eat foods made with sugar and white flour. I start doing death math. I don’t believe those hours obsessing about ways to die served me in any way. In fact, that kind of depression is a life-threatening condition that has killed almost a million people around the globe, including comedic genius Robin Williams.

In a New York Times piece titled It’s Not Always Depression, psychotherapist Hilary Jacobs Hendel describes her sessions with a patient, Brian, who came to her after years of treatment-resistant depression. He had already tried cognitive behavioral therapy, psychoanalytic psychotherapy, supportive therapy, and dialectical behavioral therapy. He had been prescribed several medication combinations, and had been hospitalized. Next on the list was electroshock therapy, which he didn’t want to do.

During her first few sessions with Brian, he was totally comatose. She writes, “He could barely bring himself to speak, and his voice, when I managed to get anything out of him, was meek. His body was rigid, his facial expression blank. He couldn’t look me in the eye. Yes, he seemed extremely depressed. But knowing he had been treated for depression for years without good results, I wondered about the diagnosis.”

She eventually diagnosed him as a survivor of childhood neglect, a kind of trauma, and proceeded with experiential dynamic psychotherapy, which focuses on “fostering awareness of the emotional life of the patient as it unfolds in real time in front of the therapist.” They worked together twice a week for four years, and he eventually let go of his shame, learned how to express his feelings, and engaged in meaningful work.

I’ve heard other stories like this that make me think that sometimes depression isn’t so much a physical disease as a spiritual and psychological condition — a kind of constipated state of mind, where your thoughts and spirit are stuck in a toxic quicksand that is swallowing you up minute by minute. In these situations, my guess is that drugs are probably less effective than a kind of psychotherapy or meditation technique or spiritual healing that confronts the source of the pain. But keep in mind I studied theology in college, not medicine.

A friend of mine who also had a traumatic childhood asked me the other day: “Do you think that the reason many of us have depression is because this is a warning signal from our minds and bodies that there is something wrong in our lives? That we are not ‘sick’ in the traditional sense, as in a diagnosis of diabetes, but we are being alerted that we have not yet reached the root psychological cause that is creating the anguish? In other words, you simply cannot put out the psychological fire until it is resolved within and that it may be so subconscious that we may not yet be aware of it?”

Six years ago I would have told her depression is always a physical condition that needs to be treated with the traditional psychiatric approach. In the years of 2005 and 2006, I spent too much time trying to locate the source of my unresolved issues, and frankly, it almost cost me my life. After all the yoga, meditation, and psychotherapy, I still had a bag of about 30 prescriptions ready to flatten my pulse. Not until I landed at Johns Hopkins Mood Disorder Clinic did I get my life back. However, during the last few years, I have seen and experienced the limitations of psychiatry and the biomedical model. I have witnessed people stay stuck, despite many sessions of ECT and medications and psychotherapy, which is why I felt strongly enough to start my foundation for intractable depression.

I would very much like to say that depression is always a disease.

It’s simpler.

Just as a diabetic needs insulin, we need antidepressants — that’s clean.

But the truth is that I have been so humbled in the last 10 years that I don’t really know what depression is and what works anymore. I appreciate that each human being is so unique with different nerve cells and tissues that it can be dangerous to make bold claims in any camp. I agree with Gordon that we need a more integrative approach to depression — one that includesnutrition, exercise, meditation, and other methods of healing like experiential dynamic psychotherapy. But I also think that we must always keep in mind that depression can be a life-threatening illness, a serious biochemical condition that we can’t think or pray ourselves out of.

We must always remember the people who did not survive this disease because they didn’t think it was a disease.

Posted in News & updates | Leave a comment

Is it Depression or a Dark Night of the Soul?

In the fall of 2007 Mother Teresa graced the cover of Time magazine when her private writingswere published, many of the excerpts filled with surprising doubt, despair, and a kind of spiritual anguish. Some journalists questioned whether or not she was clinically depressed. Did this modern saint have an untreated mood disorder or did her pain fall into the category of a “dark night of the soul,” a concept introduced by Saint John of the Cross, a Carmelite friar who lived in Spain during the late 1500s? I believe it was the latter, given her incredible productivity in the years of her struggle.

The distinction is important, even as it can be impossible to make, because many religious and spiritual people forego treatment thinking that the pain they endure is necessary to purify their souls. For example, I thought that my desire to die as a young girl meant that I was a mystic.

Gerald May, MD, a retired psychiatrist and Senior Fellow in Contemplative Theology and Psychology, discusses both in his book, The Dark Night of the Soul. When a person is clinically depressed, he explains, she loses her sense of humor and the ability to see comedy in certain situations. The person is also too shut down to reach out to others who are in pain, to offer compassion to others. She can’t see beyond her own discomfort. Clinical depression can render an energetic, sensitive person apathetic so that all her senses are disabled. Her very being seems to disappear beneath her illness. With a dark night of the soul, the person stays in tact, even though she is hurting. While a person in the midst of a dark night of the soul knows, on some level, there is a purpose to the pain, the depressed person is embittered and wants to be relieved immediately. “In accompanying people through dark-night experiences, I never felt the negativity and resentment I often felt when working with depressed people,” explains Dr. May.

Kevin Culligan, OCD, a psychologist and the former chair of the Institute of Carmelite Studies, also distinguishes between the dark night and clinical depression in his chapter in the book, Carmelite Spirituality, edited by Keith Egan, a wonderful professor of mine at Saint Mary’s College, and my thesis director for a paper I wrote on John of the Cross’ The Dark Night. Fr. Culligan explains that a clinically depressed person has a loss of energy and pleasure in most things, including hobbies and sex. He will sometimes exhibit a dysphoric mood (think Eeyore) or psychomotor retardation. The person in the midst of a dark night experiences loss, too, but more as a loss of pleasure in the things of God. Culligan can often tell the difference between the two based on his response to the person with whom he’s interacting. After listening to a depressed person, he often becomes depressed, helpless, and hopeless himself. He feels the rejection of self, as if the depression is contagious. In contrast, he is not brought down when people speak of a spiritual aridity.

I found this paragraph in Culligan’s chapter to be especially helpful:

“In the dark night of spirit, there is painful awareness of one’s own incompleteness and imperfection in relation to God; however, one seldom utters morbid statements of abnormal guilt, self-loathing, worthlessness, and suicidal ideation that accompany serious depressive episodes. Thoughts of death do indeed occur in the dark night of the spirit, such as ‘death alone will free me from the pain of what I now see in myself,’ or ‘I long to die and be finished with life in this world so that I can be with God,’ but there is not the obsession with suicide or the intention to destroy oneself that is typical of depression. As a rule, the dark nights of sense and spirit do not, in themselves, involve eating and sleeping disturbances, weight fluctuations, and other physical symptoms (such as headaches, digestive disorders, and chronic pain).”

Psychologist Paula Bloom posted an article awhile back on PBS’s “This Emotional Life” platform called “Am I Depressed or Just Deep?” She talked about how people confuse being depressed with being philosophical or deep. And I would add, “spiritually sophisticated,” the kind of person who knows what a dark night is, and believes God has allowed it to happen for a reason. Dr. Bloom explains that life is hard, it involves inexplicable tragedies, and yes, to not ever feel fear or despair or anger in light of this might question a person’s humanity. But to stay in that place — disabled by life’s blows — may mean you’re dealing with a mood disorder, not a depth of perception. In her blog, she writes:

“There are a few basic existential realities we all confront: mortality, aloneness, and meaninglessness. Most people are aware of these things. A friend dies suddenly, a coworker commits suicide or some planes fly into tall buildings — these events shake most of us up and remind us of the basic realities. We deal, we grieve, we hold our kids tighter, remind ourselves that life is short and therefore to be enjoyed, and then we move on. Persistently not being able to put the existential realities aside to live and enjoy life, engage those around us or take care of ourselves just might be a sign of depression.”

Both Culligan and May agree that a person can be experiencing BOTH a dark night and clinical depression, that sometimes they are impossible to tease apart. “Since the dark night and depression so often coexist, trying to distinguish one from the other is not as helpful as it might first appear,” writes May. “With today’s understanding of the causes and treatment of depression, it makes more sense simply to identify depression where it exists and to treat it appropriately, regardless of whether it is associated with a dark-night experience.”

Posted in News & updates | Leave a comment

5 Ways to Manage the Summer Blues

Picnics at the beach.

Afternoons by the pool.

Three months of summer bliss.

Or not.

For many people, the summer months are the most difficult. In fact, 10 percent of those diagnosed with Seasonal Affective Disorder suffer symptoms at the brightest time of the year. The summer’s brutal heat, bright light, and long days can contribute to depression for the opposite reasons that the winter does. Like typical SAD, the change of light can affect a person’s circadium rhythm, which may disturb overall health and sleep patterns. But you don’t need to suffer from summer SAD to slog through the hot days. A substantial part of the population does just that in June, July, and August. Here are a few ways to manage the summer blues.

1. Hydrate

When you consider that brain tissue is 85 percent water and our bodies are 70 percent water, it’s easier to understand why hydrating yourself is so important. Dehydration causes a shortage oftryptophan, an important amino acid that is converted to serotonin in the brain. Our bodies can’t detoxify when there is a shortage of water, so tryptophan isn’t distributed to the necessary parts of the brain. Low levels of amino acids in the body can contribute to depression, anxiety, and irritability.

Even mild dehydration—approximately 1.5 percent loss in normal water volume — can affect our moods and impair our concentration. According to two recent studies at the University of Connecticut’s Human Performance Laboratory, it didn’t matter if a person walked for 40 minutes on a treadmill or was at rest. The negative effects of dehydration were the same.

2. Stay away from diet soda

It’s easy to grab a Diet Coke when you feel hot and thirsty, but a recent study by the National Institute of Health showed that people who drink four cans or more of diet soda daily are about 30 percent more likely to be diagnosed with depression than people who don’t drink soda. Coffee drinkers are about 10 percent less likely to develop depression than people who don’t drink coffee. People with mood disorders are especially sensitive to the superficial sweeter aspartame in most diet sodas. In fact, a 1993 study conducted by Ralph Walton, M.D., of Northeastern Ohio Universities College of Medicine found that there was a significant difference between aspartame and placebo in both number and severity of symptoms for people with a history of depression, but not so for persons with no history of a mood disorder.

3. Eat ice-cream!

Research published in the journal “Nature Neuroscience” explored the relationship between comfort food and mood. While it didn’t state that eating a pint of Ben & Jerry’s is equivalent to popping a Prozac, studies did discover that the brain chemical that motivates us to eat, called ghrelin, can act like a kind of antidepressant. Ghrelin rises before meals and is associated with feelings of hunger. In an essay for ABC News, James Potash, M.D., co-director of the Mood Disorder Program at the Johns Hopkins School of Medicine, explains this formulation: Stress gets us upset and feeling low. Ghrelin picks us back up some, and also makes us hungrier, and so we eat ice cream. And then we associate the ice cream with feeling better. The ice cream, then, isn’t the antidepressant. But there is a strong enough connection here that I say, eat up!

4. Create some structure

We, humans, thrive on structure. Some of us—like those with a history of depression or anxiety–more so than others. For that subgroup, structure is essential for sanity. Summer destroys most of our schedules, especially if you have little kids out of school, young adults home for the summer, or other persons in your house who have invited themselves to live with you for three months. Therefore, you have to literally force some structure into your day. I keep my alarm set to the same hour I wake up during the year and swim at 6 a.m. even though the house is sleeping in. I have created a routine—working out of a certain coffee shop on Mondays and Wednesdays, where I attempt to crank out one piece before lunch. I avoid my home as much as I can, because I know I will get dragged into tasks that will distract me from my responsibilities and interrupt my schedule. I turn into a rigid, unlikeable person.

5. Squeeze in some leisure

If you’re like me, you struggle with lying in a hammock. I can’t turn off my mind, which is worried about an average of three things all the time. I guess you could call me “relaxation challenged.” I need to enroll in relaxation school, where I can learn how to sway a hammock. Back and forth. Back and forth. A little bit of leisure is as important as eight hours of sleep or omega 3 fatty acids in maintaining sanity and regulating mood. When done regularly, leisure combats stress and boosts our immune systems. When Salvatore R. Maddi studied the effects of stress on 2,000 people, there was a population that was more protected from the internal symptoms of stress, including depression and anxiety. What did the people in this group have in common? The primary distinguishing feature was four to six hours of “meaningful activity.”

Posted in News & updates | Leave a comment

Why Sugar Is Poison for Depression

I have a theory: Many people who suffer from chronic severe depression and anxiety are allergic to sugar and foods like white flour that the human body processes like sugar.

Like most of my theories, I have tested this one on my 13-year-old son, because his brain is most like mine in our family (poor guy). After he has consumed three pumpkin muffins, his character completely changes, like the Green Goblin (Norman Osborn) in Spider-Man.

Depending on the amount of fructose corn syrup in the muffins, his head sometimes spins around like Linda Blair‘s in The Exorcist, and his pupils can do a 360 in the eye sockets. He is horribly obnoxious for about three hours — twerking at the refrigerator, riding his lacrosse stick like a horse through the living room — and then he starts sobbing: “I hate my life!! Someone please shoot me!” Often the next morning he will wake up hungover, with purple circles under his swollen eyes.

You would think that two somewhat intelligent parents would have picked up on this connection between his behavior and his diet in the first decade of his life, but it has only been in the last year we’ve been documenting the experiment. It’s harder than you think to get your kid excited about vegetables and steer him away from any kind of food offered in a vending machine. Whenever we try to encourage positive eating habits, something seems to go terribly wrong. Like the time we thought we’d have a fun family outing at Potbelly.

Eric: “David, do you think you could get a salad?”

Katherine (11-year-old): “I’m getting a sub!”

David (crying): “It’s not fair! I hate my brain!”

Eric: “Well, Katherine didn’t get the skinny gene.”

Katherine (crying): “You think I’m fat!”

Eric: “Let’s just go home.

I feel badly for my little guy because I know how delicate he is. Three pumpkin muffins would also have me thinking, “I hate my life; please shoot me.” I just don’t say it aloud. I blog about it. Seeing his reactions to Oreo cookies and frappuccinos, however, confirms my theory on sugar, that some homo sapiens can’t handle the chemical formula C12H22O11.

Sugar and the Depressed Brain

In his bestseller The Ultramind Solution, Mark Hyman, MD, writes:

“There is no scientific controversy here. The evidence is in. Sugar causes inflammation. The insulin-resistant fat cells you pack on when you eat too much sugar produces nasty inflammatory messages (cytokines) … spreading their damage to the brain. In fact, researchers have suggested calling depression “metabolic syndrome Type II” because instead of just having a fat swollen belly, you also get a fat swollen (and depressed) brain. And psychiatrists are starting to treat depression and psychiatric disorders with anti-diabetic drugs like Actos! These drugs lower blood sugar, lower insulin, and reduce inflammation.”

Besides causing insulin and blood sugar imbalances, refined carbohydrates and sugars use up the B vitamins we need to sustain good moods. In a study published in British Journal of Psychiatry, 3,500 middle-aged participants were given a diet of whole foods (plenty of vegetables, fruit, and fish) or a diet of processed foods (loaded with desserts, fried food, and refined grains). Five years later, the processed-foods group had a 58 percent increased risk for depression, while the whole-foods group had a 26 percent reduced risk of depression. The right foods seem to be able to protect a person, to some extent, from developing a mood disorder.

Sugar Sins: Aggressive Behavior, Anxiety, Fatigue

At the Brain Bio Center, a nonprofit clinic run by FoodfortheBrain.org to help people use nutrition, diet, and lifestyle recommendations to assist mental health conditions, the specialists say that poor blood sugar is often the single biggest factor in mood disorders among the people who seek their advice. In their article on depression, they write:

“Eating lots of sugar is going to give you sudden peaks and troughs in the amount of glucose in your blood; symptoms that this is going on include fatigue, irritability, dizziness, insomnia, excessive sweating (especially at night), poor concentration and forgetfulness, excessive thirst, depression and crying spells, digestive disturbances and blurred vision. Since the brain depends on an even supply of glucose it is no surprise to find that sugar has been implicated in aggressive behavior, anxiety, and depression, and fatigue.”

Sugar also messes with your thyroid, the unassuming butterfly-shaped gland at the base of your neck that performs the responsibilities of a Grand Central Station for your body, determining how your body uses energy and makes proteins. Thyroid hormones are responsible for regulating metabolism, growth and development, and body temperature. They are also critical to mood.

Sugar and ‘Death Math’

Hashimoto’s thyroiditis, an autoimmune disease affecting the thyroid gland, is what made journalist and television host Sara Wilson quit sugar three years ago. Wilson writes:

“It pretty much crippled me a few years ago, some side effects of which included: whacked-out blood sugar, screwed-up hormones, a predisposition to diabetes and high cholesterol, mood fluctuations, weakness to the point of not being able to work or walk for nine months, weight gain and much more. All of the above are now stable or overcome … I’ve wiped out my antibody markers, something my doctors find astounding. I believe quitting sugar did this.”

I read her bestselling book, I Quit Sugar, about a year ago, but it took me nine more months to commit. I had to feel miserable enough to want to eliminate the foods I adore: dark chocolate, sugar cookies, caramel apples. At Thanksgiving dinner last year, I devoured a delicious piece of pumpkin pie with a generous scoop of vanilla ice-cream and lots of whipped cream. Then, for two days, I cried nonstop and did “death math,” where you add up the ages of all your relatives and divide by how many you have to see what average age of death you get — the number of years you have to hang on to, to make it to a natural death.

That was more than three months ago. Since then my mood has been much more stable and my sessions of death math are less frequent.

There is something to my theory.

Now if I can just get my son to stay away from the pumpkin muffins.

Posted in News & updates | Leave a comment

Top 5 Hidden Causes of Depression

Last year, I was seeing four different doctors: a psychiatrist for my mood disorder; an endocrinologist for my pituitary tumor and thyroid issues; a cardiologist for my aortic valve regurgitation; and a primary care physician for some digestive problems and fungus growth.

I suspected that all of my health problems were connected, but each doctor refused to look beyond her specialty to achieve a systemic, balanced perspective of how the conditions were related. I searched for an integrative doctor who could piece together all of my broken parts and help me determine underlying causes for all of the ailments. After spending a few months with a functional doctor who was very anti-medication, I finally — much like Goldilocks — found the right physician: an internist who was willing to look through my files from past doctors and X-rays that exist somewhere on the Internet in order to gain a holistic view at my health.

I believe the vast majority of persons who have been told their depression is treatment resistantcan benefit from working with an integrative doctor — someone who considers all of your biological systems and organs when trying to determine the reason why you don’t want to get out of bed in the morning. However, many integrative doctors are expensive and don’t take insurance, so I thought I would interview my doctor, Alan Weiss, MD (pictured above), to provide you with some ideas about next steps to take if you are stuck and not getting better.My biggest frustration with psychiatry is that most psychiatrists won’t consider any contributing factors below the neck. So when people like me don’t get better after 20, 30, 40, or 50 medication combinations, they aren’t sure what to do. They tell us we can try brain stimulation possibilities, like transcranial magnetic stimulation (TMS) or electroconvulsive therapy (ECT). Or we will have to learn to live around our death thoughts and suicidal ideations.

Dr. Weiss serves as the medical director of Annapolis Integrative Medicine. He earned his bachelors degree from the University of Virginia and his medical degree from McGill University. He is board certified in internal medicine and is a fellow of the American Academy for Advancement in Medicine and the American College of Physicians. He has practiced medicine for more than 15 years. He had conducted studies and published articles relating to diabetes, chronic pain, fibromyalgia, and chronic fatigue syndrome. Weiss’ goal is to educate and treat his patients by incorporating the latest research in the areas of conventional and alternative medicine. He continues to pursue and educate himself in leading-edge methods of achieving wellness.

I’m pleased to share some of what I have learned from him with you.

TB: What are the primary underlying or accompanying causes of depression that you’ve encountered in your years practicing internal medicine?

AW: The top five underlying causes of depression that I see in my patients are a bad diet, leaky gut, sleep disorders, hypothyroidism, and low vitamin D and B-12.

1. Bad diet: I don’t think people truly understand the impact of what they eat on their mood. Processed foods, hydrogenated oils, sugar, and lots of bread and cracker-like snacks can certainly contribute to symptoms of depression and anxiety. For optimal mental health, I advise my patients to eat a clean, Paleo (also called primal or ancestral) diet: eating whole or nutrient-dense foods, and avoiding refined sugar, gluten, pasteurized dairy products, and processed factory foods like Fritos and Oreos. I also recommend taking fish oil supplements, vitamins B-12 and D, a multi-vitamin, and a multi-mineral.

2. Leaky gut: Leaky gut is clinically known as increased intestinal permeability or hyperpermeability, a condition in which food is allowed to pass through the small intestinal lining. Substances leak into the bloodstream that shouldn’t be there, causing bloating, gas, and sometimes mood disturbances.

3. Sleep disorders: We’ve always known that depression causes interruptions in sleep, and that a lack of sleep makes persons more susceptible to mood disorders. But studies now show that sleep problems can cause mood disorders and that sleep deprivation can rewire the brain’s emotional circuits.

4. Hypothyroidism: Since most psychiatrists and primary-care physicians don’t run a full thyroid panel, I see a number of patients who have undiagnosed hypothyroidism, an underactive thyroid, which causes symptoms of fatigue, apathy, and depression.

5. Low vitamin D and B-12: These are the two most common nutrient deficiencies for my patients who have depression symptoms. Both vitamin D and B-12 are essential for positive mood.

TB: Why don’t some people get better after working tirelessly with a psychiatrist?

AW: They may not be addressing root medical issues like the ones I mention above: hypothyroidism, leaky gut, sleep disorders, and vitamin deficiencies. Some people being treated with medications need cognitive behavioral therapy, as well, or vice versa. Patients can have food allergies and food intolerances that affect mood, or they have toxicities — such as mercury poisoning — that an antidepressant can’t treat. Addictions can prevent recovery from depression, or less-than-full disclosure about something like an addiction with a psychiatrist. And there are always some people who are just simply being treated for the wrong things.

TB: What are the best blood tests to have their primary care physician run? What should a person do who can’t afford to see a functional or integrative doctor? 

AW: I would have your doctor run a full thyroid panel that should include TSH, Free T4, Free T3, Reverse T3, and Thyroid Antibodies. Test for deficiencies in vitamin D, B-12, ferritin, and iron. Rule out food allergies by doing an elimination diet. Simply remove specific foods from your diet for a few weeks that you suspect could be causing allergy symptoms (milk, eggs, nuts, wheat, and soy are typical triggers). Keep a food diary to record the foods you are eating and omitting, and if the symptoms disappear when you stop eating them. Slowly add back in the suspicious foods, one at a time (give yourself a week between each reintroduction). Record any allergic symptom you feel as you add each food in. That should help you confirm that the food is triggering the symptom.

TB: What recommendations or advice would you give a person who fights chronic depression or anxiety?

AW: My advice is to clean up your diet, exercise on a regular basis, optimize your hormones (for example, get a full thyroid panel done to be sure your thyroid isn’t underactive), clean up any integrity issues you may have in your life. If the depression continues, you may need to change something else in your life.

Posted in News & updates | Leave a comment

Meditation Programs for Psychological Stress and Well-Being

Introduction

Definition of Meditation

The National Center for Complementary and Alternative Medicine defines meditation as a “mind-body” method. This category of complementary and alternative medicine includes interventions that employ a variety of techniques that facilitate the mind’s capacity to affect bodily function and symptoms. In meditation, a person learns to focus attention. Some forms of meditation instruct the student to become mindful of thoughts, feelings, and sensations, and to observe them in a nonjudgmental way. Many believe this practice evokes a state of greater calmness, physical relaxation, and psychological balance.1

Current Practice and Prevalence of Use

Many people use meditation to treat stress and stress-related conditions, as well as to promote general health.2,3 A national survey in 2008 found that the number of people meditating is increasing, with approximately 10 percent of the population having some experience with meditation.2 A number of hospitals and programs offer courses in meditation to patients seeking alternative or additional methods to relieve symptoms or to promote health.

Forms of Meditation

Meditation training programs vary in several ways, including the emphasis on religion or spirituality, the type of mental activity promoted, the nature and amount of training, the use of an instructor, and the qualifications of an instructor, which may all affect the level and nature of the meditative skills learned. Some meditative techniques are integrated into a broader alternative approach that includes dietary and/or movement therapies (e.g., ayurveda or yoga).

Researchers have categorized meditative techniques as emphasizing “mindfulness,” “concentration,” and “automatic self-transcendence.” Popular techniques such as transcendental meditation (TM) emphasize the use of a mantra in such a way that one “transcends” to an effortless state where there is no focused attention. Other popular techniques, such as mindfulness-based stress reduction (MBSR), are classified as “mindfulness” and emphasize training in present-focused awareness. Uncertainty remains about the extent to which these distinctions actually influence psychosocial stress outcomes.

Psychological Stress and Well-Being

Researchers have postulated that meditation programs may affect a range of outcomes related to psychological stress and well-being. The research ranges from the rare examination of positive outcomes, such as increased well-being, to the more common approach of examining reductions in negative outcomes, such as anxiety or sleep disturbance. Some studies address symptoms related to the primary condition (e.g., pain in patients with low back pain or anxiety in patients with social phobia), whereas others address similar emotional symptoms in clinical groups of people who may or may not have clinically significant symptoms (e.g., anxiety or depression in individuals with cancer).

Evidence to Date

Reviews to date have demonstrated that both “mindfulness” and “mantra” meditation techniques reduce emotional symptoms (e.g., anxiety and depression, stress) and improve physical symptoms (e.g., pain) from a small to moderate degree.4-23 These reviews have largely included uncontrolled studies or studies that used control groups that did not receive additional treatment (i.e., usual care or wait list). In wait-list controlled studies, the control group receives usual care while “waiting” to receive the intervention at some time in the future, providing a usual-care control for the purposes of the study. Thus, it is unclear whether the apparently beneficial effects of meditation training are a result of the expectations for improvement that participants naturally form when obtaining this type of treatment. Additionally, many programs involve lengthy and sustained efforts on the part of participants and trainers, possibly yielding beneficial effects from the added attention, group participation, and support participants receive, as well as the suggestion that symptoms will likely improve with these increased efforts.24,25

The meditation literature has significant limitations related to inadequate control comparisons. An informative analogy is the use of placebos in pharmaceutical trials. The placebo is typically designed to match the “active intervention” in order to elicit the same expectations of benefit on the part of both provider and patient, but not contain the “active” ingredient. Additionally, placebo treatment includes all components of care received by the active group, including office visits and patient-provider interactions. These nonspecific factors are particularly important to control when the evaluation of outcome relies on patient reporting. In this situation, in which double-blinding has not been feasible, the challenge to execute studies that are not biased by these nonspecific factors is more pressing.25 Thus, there is a clear need to examine the specific effects of meditation in randomized controlled trials (RCTs) in which expectations for outcome and attentional support are controlled.

Clinical and Policy Relevance

There is much uncertainty regarding the differences and similarities between the effects of different types of meditation.26,27 Given the increasing use of meditation across a large number of conditions, it is important for patients, clinicians, and policymakers to understand the effects of meditation, types and duration of meditation, and settings and conditions for which meditation is efficacious. While some reviews have focused on RCTs, many, if not most, of the included studies involved wait-list or usual-care controls. Thus, there is a need to examine the specific effects of meditation interventions relative to conditions in which expectations for outcome and attentional support are controlled.

Objectives

The objectives of this systematic review are to evaluate the effects of meditation programs on affect, attention, and health-related behaviors affected by stress, pain, and weight among people with a medical or psychiatric condition in RCTs with appropriate comparators.

Scope and Key Questions

This report reviews the efficacy of meditation programs on psychological stress and well-being among those with a clinical condition. “Affect” refers to emotion or mood. It can be positive, such as the feeling of well-being, or negative, such as anxiety, depression, or stress. Studies usually measure affect through self-reported questionnaires designed to gauge how much someone experiences a particular affect. “Attention” refers to the ability to maintain focus on particular stimuli; clinicians measure this directly. Studies measure substance use as the amount consumed or smoked over a period of time, and include alcohol consumption, cigarette smoking, and use of other drugs such as cocaine. They measure sleep as the amount of time spent asleep versus awake or as overall sleep quality. Studies measure sleep time through either polysomnography or actigraphy, and sleep quality through self-reported questionnaires. They measure eating using food diaries to calculate how much energy or fat a person has consumed over a particular period of time. They measure pain similarly to affect, by a self-reported questionnaire to assess how much pain an individual is experiencing. Studies measure pain severity on a numerical rating scale from 0 to 10 or by using other self-reported questionnaires. The studies measure weight in pounds or kilograms.

The Key Questions are as follows:

Key Question 1. What are the efficacy and harms of meditation programs on negative affect (e.g., anxiety, stress) and positive affect (e.g., well-being) among those with a clinical condition (medical or psychiatric)?

Key Question 2. What are the efficacy and harms of meditation programs on attention among those with a clinical condition (medical or psychiatric)?

Key Question 3. What are the efficacy and harms of meditation programs on health-related behaviors affected by stress, specifically substance use, sleep, and eating, among those with a clinical condition (medical or psychiatric)?

Key Question 4. What are the efficacy and harms of meditation programs on pain and weight among those with a clinical condition (medical or psychiatric)?

Analytic Framework

Figure A. Analytic framework for meditation programs conducted in clinical and psychiatric populations

Figure A illustrates our analytic framework for the systematic review. The figure indicates the populations of interest, the meditation programs, and the outcomes that we reviewed. This figure depicts the Key Questions (KQs) within the context of the population, intervention, comparator, outcomes, timing, and setting (PICOTS) framework described in Table A. Adverse events may occur at any point after the meditation program has begun.

Figure A illustrates our analytic framework for the systematic review. The figure indicates the populations of interest, the meditation programs, and the outcomes that we reviewed. This figure depicts the Key Questions (KQs) within the context of the population, intervention, comparator, outcomes, timing, and setting (PICOTS) framework described in Table A. Adverse events may occur at any point after the meditation program has begun.

KQ = Key Question

Methods

Literature Search Strategy

We searched the following databases for primary studies through November 2012: MEDLINE®, PsycINFO®, Embase®, PsycArticles, SCOPUS, CINAHL, AMED, and the Cochrane Library. We developed a search strategy for MEDLINE, accessed via PubMed®, based on medical subject headings (MeSH®) terms and text words of key articles that we identified a priori. We used a similar strategy in the other electronic sources. We reviewed the reference lists of included articles, relevant review articles, and related systematic reviews (n=20) to identify articles that the database searches might have missed. We did not impose any limits based on language or date of publication.

Study Selection

Two trained investigators independently screened articles at the title-and-abstract level and excluded them if both investigators agreed that the article met one or more of the exclusion criteria (Table A). We resolved differences between investigators regarding abstract eligibility through consensus.

Paired investigators conducted a second independent review of the full-text article for all citations that we promoted on the basis of title and abstract. We resolved differences regarding article inclusion through consensus.

Paired investigators conducted an additional independent review of full-text articles to determine if they adequately addressed the KQs and should be included in this review.

We included RCTs in which the control group was matched in time and attention to the intervention group for the purpose of matching expectations of benefit. The inclusion of such trials allowed us to evaluate the specific effects of meditation programs separately from the nonspecific effects of attention and expectation. Our team thought this was the most rigorous way to determine the efficacy of the interventions. We did not include observational studies because they are likely to have a high risk of bias due to problems such as self-selection of interventions (since people who believe in the benefits of meditation or who have prior experience with meditation are more likely to enroll in a meditation program) and use of outcome measures that can be easily biased by participants’ beliefs in the benefits of meditation.

For inclusion in this review, we required that studies reported on participants with a clinical condition such as medical or psychiatric populations. Although meditation programs may have an impact on healthy populations, we limited our evaluation of these meditation programs to clinical populations. Since trials study meditation programs in diverse populations, we have defined clinical conditions broadly to include mental health/psychiatric conditions (e.g., anxiety or stress) and physical conditions (e.g., low back pain, heart disease, or advanced age). Additionally, since stress was of particular interest in meditation studies, we also included trials that studied stressed populations even though they may not have a defined medical or psychiatric diagnosis. We excluded studies among otherwise healthy populations.

Table A. Study inclusion and exclusion criteria
PICOTS Element Inclusion Exclusion
ACT = acceptance and commitment therapy; DBT = dialectical behavioral therapy; MBCT = mindfulness-based cognitive therapy; MBSR = mindfulness-based stress reduction; PICOTS = population, intervention, comparison, outcome, timing, and setting; RCT = randomized controlled trial; TM = transcendental meditation
Note: We excluded articles with no original data (reviews, editorials, and comments), studies published in abstract form only, and dissertations.
Population and Condition of Interest
  • Adult populations (18 years or older)
  • Clinical (medical or psychiatric) diagnosis, defined as any condition (e.g., high blood pressure, anxiety) including a stressor
  • Studies of children (The type and nature of meditation children receive are significantly different from those for adults.)
  • Studies of otherwise healthy individuals
Interventions Structured meditation programs (any systematic or protocolized meditation programs that follow predetermined curricula) consisting of at least 4 hours of training with instructions to practice outside the training session

These include:

  • Mindfulness-based:
    • MBSR
    • MBCT
    • Vipassana
    • Zen
    • Other mindfulness meditation
  • Mantra-based:
    • TM
    • Other mantra meditation
  • Other meditation
Meditation programs in which the meditation is not the foundation and majority of the intervention

These include:

  • DBT
  • ACT
  • Any of the movement-based meditations, such as yoga (e.g., Iyengar, hatha, shavasana), tai chi, and qi gong (chi kung)
  • Aromatherapy
  • Biofeedback
  • Neurofeedback
  • Hypnosis
  • Autogenic training
  • Psychotherapy
  • Laughter therapy
  • Therapeutic touch
  • Eye movement desensitization reprocessing
  • Relaxation therapy
  • Spiritual therapy
  • Breathing exercise, pranayama
  • Exercise
  • Any intervention that is given remotely or only by video or audio to an individual without the involvement of a meditation teacher physically present
Comparisons of Interest Active control is defined as a program that is matched in time and attention to the intervention group for the purpose of matching expectations of benefit. Examples include “attention control,” “educational control,” or another therapy, such as progressive muscle relaxation, that the study compares with the intervention.

  • A nonspecific active control matches only time and attention and is not a known therapy.
  • A specific active control compares the intervention with another known therapy, such as progressive muscle relaxation.
Studies that evaluate only a wait-list/usual-care control or do not include a comparison group
Outcomes See Figure A All other outcomes
Study Design RCTs with an active control Nonrandomized designs, such as observational studies
Timing and Setting Longitudinal studies that occur in general and clinical settings None

Data Abstraction and Data Management

We used DistillerSR (Evidence Partners, 2010) to manage the screening process. DistillerSR is a Web-based database management program that manages all levels of the review process. We uploaded all the citations our search identified to this system.

We created standardized forms for data extraction and pilot tested them. Reviewers extracted information on general study characteristics, study participants, eligibility criteria, interventions, and outcomes. Two investigators reviewed each article for data abstraction. For study characteristics, participant characteristics, and intervention characteristics, the second reviewer confirmed the first reviewer’s data abstraction for completeness and accuracy. For outcome data and risk-of-bias scoring, we used dual and independent review. Reviewer pairs included personnel with both clinical and methodological expertise. We resolved differences between investigators regarding data through consensus.

For each meditation program, we extracted information on measures of intervention fidelity, including dose, training, and receipt of intervention. We measured duration and maximal hours of structured training in meditation, amount of home practice recommended, description of instructor qualifications, and description of participant adherence, if any.

Data Synthesis

For each KQ, we created a detailed set of evidence tables containing all information abstracted from eligible studies.

To display the outcome data, we calculated relative difference-in-change scores (i.e., the change from baseline in an outcome measure in the treatment group minus the change from baseline in the outcome measure in the control group, divided by the baseline score in the treatment group). However, many studies did not report enough information to calculate confidence intervals for the relative difference-in-change scores. When we evaluated point estimates and confidence intervals for just the postintervention or end-of-study differences between groups and compared these with the point estimates for the relative difference-in-change scores for those time points, some of the estimates that did not account for baseline differences appeared to favor a different group (e.g., treatment or control) when compared with the estimates that accounted for baseline differences. We therefore used the relative difference-in-change scores to estimate the direction and approximate magnitude of effect for all outcomes. For the purpose of generating an aggregate quantitative estimate of the effect of an intervention and the associated 95-percent confidence interval, we performed meta-analysis using standardized mean differences (effect sizes) calculated by Cohen’s method (Cohen’s d). We also used these to assess the precision of individual studies, which we factored into the overall strength of evidence (SOE). For each outcome, we displayed the resulting effect-size estimate according to the type of control group and duration of followup. Some studies did not report enough information to be included in meta-analysis. For that reason, we decided to display the relative difference-in-change scores along with the effect-size estimates from meta-analysis so that readers can see the full extent of the available data.

We considered a 5-percent relative difference-in-change score to be potentially clinically significant, since these studies were looking at short interventions and relatively low doses of meditation. In synthesizing the results of these trials, we considered both statistical and clinical significance. Statistical significance is determined according to study-specific criteria; we reported p-values and confidence intervals for these where present.

Trials used either nonspecific active controls or specific active controls (TableA, Figure A). Nonspecific active controls (e.g., education control or attention control) are used to control for the nonspecific effects of time, attention, and expectation. Comparisons against these controls allow for assessments of the specific effectiveness of the meditation program above and beyond the nonspecific effects of time, attention, and expectation. Such a comparison is similar to a comparison against a placebo pill in a drug trial, where one is concerned with the nonspecific effects of interacting with a provider, taking a pill, and expecting the pill to work. Specific active controls are therapies (e.g., exercise or progressive muscle relaxation) known or expected to change clinical outcomes. Comparisons against these controls allow for assessments of comparative effectiveness and are similar to comparing one drug against another known drug in a drug trial. Since these study designs using different types of controls are expected to yield quite different conclusions (effectiveness vs. comparative effectiveness), we separated them in our analyses.

Assessment of Methodological Quality of Individual Trials

We assessed the risk of bias in studies independently and in duplicate based on the recommendations in the Evidence-based Practice Center “Methods Guide for Effectiveness and Comparative Effectiveness Reviews” (Methods Guide).28 We supplemented these tools with additional assessment questions based on the Cochrane Collaboration’s risk-of-bias tool.29,30 While many of the tools to evaluate risk of bias are common to behavioral as well as pharmacologic interventions, some items are more specific to behavioral interventions. After discussion with experts in meditation programs and clinical trials, we emphasized four major and four minor criteria. We assigned 2 points each to the major criteria, weighting them more than the minor criteria in assessing risk of bias. We assigned 1 point each to the minor criteria. Studies could therefore receive a total of 12 points. If studies met a minimum of three major criteria and three minor criteria (9–12 points), we classified them as having “low risk of bias.” We classified studies receiving 6–8 points as having “medium risk of bias,” and studies receiving 5 or fewer points as having “high risk of bias”.

Assessment of Potential Publication Bias

We planned to use funnel plots to assess potential publication bias if numerous studies reported on an outcome of interest. We also searched for any trials on clinicaltrials.gov that completed recruitment 3 or more years ago and did not publish results, or listed outcomes for which they did not report results.

Strength of the Body of Evidence

Two reviewers graded the strength of evidence for each outcome for each of the KQs using the grading scheme recommended by the Methods Guide. In assigning evidence grades, we considered four domains: risk of bias; directness, consistency, and precision. We classified evidence into four basic categories: (1) “high” grade, indicating high confidence that the evidence reflects the true effect, and further research is very unlikely to change our confidence in the estimate of the effect; (2) “moderate” grade, indicating moderate confidence that the evidence reflects the true effect, and further research may change our confidence in the estimate of the effect and may change the estimate; (3) “low” grade, indicating low confidence that the evidence reflects the true effect, and further research is likely to change our confidence in the estimate of the effect and is likely to change the estimate; and (4) “insufficient” grade, indicating that evidence is unavailable or inadequate to draw a conclusion.

List of major and minor criteria in assessing risk of bias

Major Criteriaa
  • Was the control matched for time and attention by the instructors?
  • Was there a description of withdrawals and dropouts?
  • Was attrition <20% at the end of treatment? As several studies did not calculate attrition starting from the original number randomized, we recalculated the attrition from the original number randomized.
  • Were those who collected data on the participants blind to the allocation?
Minor Criteriaa
  • Was the method of randomization described in the article? To answer yes for this question, the trials had to give some description of the randomization procedure.
  • Was allocation concealed?
  • Was intent-to-treat analysis used? To answer yes for this question, the trial must impute noncompleter or other missing data, and it must do this from the original number randomized.
  • Did the trial evaluate the credibility, and if so, was it comparable? If the trial did not evaluate credibility, or if it evaluated credibility but did not find it comparable, then we did not give the trial a point.

aWe assigned 2 points each to the major criteria in assessing risk of bias, and 1 point each to the minor criteria.

Applicability

We assessed applicability separately for the different outcomes of benefit and harm for the entire body of evidence guided by the PICOTS framework, as recommended in the Methods Guide.28 We assessed whether findings were applicable to various ethnic groups, and whether race, ethnicity, or education limited the applicability of the evidence.

Results

Literature Search Results

The literature search identified 17,801 unique citations. During the title-and-abstract screening, we excluded 16,177 citations. During the article screening, we excluded 1,447 citations. During KQ applicability screening, we excluded an additional 136 articles that did not meet one or more of the inclusion criteria. We included 41 articles in the review.31-71

Most trials were short term, but they ranged from 4 weeks to 9 years in duration. Since the amount of training and practice in any meditation program may affect its results, we collected this information and found a fair range in the quality of information. Not all trials reported on amount of training and home practice recommended. MBSR programs typically provided 20–27.5 hours of training over 8 weeks. The mindfulness meditation trials typically provided about half this amount. TM trials provided 16–39 hours over 3–12 months, while other mantra meditation programs provided about half this amount. Only five of the trials reported the trainers’ actual meditation experience (ranging from 4 months to 25 years), and six reported the trainers’ actual teaching experience (ranging from 0 to 15.7 years).

Findings

Of the 41 trials we reviewed, 15 studied psychiatric populations, including those with anxiety, depression, stress, chronic worry, and insomnia. Five trials studied substance-abusing populations such as smokers and alcoholics, 5 studied chronic pain populations, and 16 studied diverse medical populations, including those with heart disease, lung disease, breast cancer, diabetes, hypertension, and HIV.

The strength of evidence on the outcomes of our review is shown in Tables B and C. Since there were numerous scales for the different measures of affect, we organized the scales to best represent the clinically relevant aspects of each affect. For this review, the comparisons with nonspecific active controls provided efficacy data, whereas comparisons with specific active controls provided comparative effectiveness data. We found it difficult to draw comparative effectiveness conclusions from comparisons with specific active controls due to the large heterogeneity of type and strength of control groups. Therefore, we presented our results first for all the comparisons with nonspecific active controls in Table B (efficacy), and then for the specific active controls inTable C (comparative effectiveness).

The direction and magnitude of effect are derived from the relative difference between groups in the change score. In our efficacy analysis (Table B) we found low SOE of no effect or insufficient evidence that mantra meditation programs had an effect on any of the psychological stress and well-being outcomes we examined in these diverse adult clinical conditions.

Mindfulness meditation programs had moderate SOE for improvement in anxiety (effect size [ES], 0.40; confidence interval [CI], 0.08 to 0.71 at 8 weeks; ES, 0.22; CI, .02 to .43 at 3–6 months); depression (ES, 0.32; CI, −.01 to +0.66 at 8 weeks; ES, 0.23; CI, .05 to .42 at 3–6 months); and pain (ES, 0.33; CI, .03 to .62); and they had low SOE for improvement in stress/distress and mental health–related quality of life. We found either low SOE of no effect or insufficient SOE of an effect of meditation programs on positive mood, attention, and weight. We also found insufficient evidence that meditation programs had an effect on health-related behaviors affected by stress, including substance use and sleep.

In our comparative effectiveness analyses (Table C), we found low SOE of no effect or insufficient SOE that meditation programs were more effective than exercise, progressive muscle relaxation, cognitive-behavioral group therapy, or other specific comparators in changing any outcomes of interest.

Harm Outcomes for All Key Questions

Few trials reported on potential harms of meditation programs. Of the nine trials that reported on harms, none reported any harms of the intervention. One trial specified that the researchers looked for toxicities of meditation to hematologic, renal, and liver markers and found none. The remaining eight trials did not specify the type of adverse event they were looking for. Seven reported that they found no significant adverse events, while one did not comment on adverse events. The remaining 32 trials did not report whether they monitored for adverse events.

Table B. Summary across measurement domains of comparisons of meditation with nonspecific active controls
Outcome Meditation Program Population Directiona
(Magnitudeb) of Effect
Number of Trials—
Total [PO]: PA (MA);c Total N
SOEd Effect-size Estimates Using Cohen’s de
This is the direction of change in the outcome across trials based on the relative difference between groups in how the outcome measure changed from baseline in each trial. We calculate it as the difference between the change over time in the meditation group and the change over time in the control group, divided by the baseline mean for the meditation group.

  • ↑ indicates that the meditation group improved relative to the control group (with a relative difference generally greater than or equal to 5% across trials).
  • ↓ indicates the meditation group worsened relative to the control group (with a relative difference generally greater than or equal to 5% across trials).
  • Ø indicates a null effect (with a relative difference generally less than 5% across trials).
  • ↑↓ indicates inconsistent findings. Some trials reported improvement with meditation relative to control, while others showed no improvement or improvement in the control group relative to meditation.

This is the range of estimates across all trials in a particular domain based on the relative difference between groups in how the outcome measure changed from baseline in each trial. It is a relative percentage difference calculated as: {# (Meditation T2 – Meditation T1) – (Control T2 – Control T1)}/ (Meditation T1), where T1 = baseline mean and T2 = followup mean (after intervention or at the end of the study). This is a simple range of estimates, not a meta-analysis.
This is the number of trials that measured the outcome: primary outcome (PO), the number of trials for which this outcome was a primary outcome; primary analysis (PA), the number of trials that reported information that allowed us to calculate the relative difference between groups in the change score; and meta analysis (MA), the number of trials reporting sufficient information to be included in a meta-analysis. N refers to total sample size.
We based SOE on the aggregate risk of bias, consistency across studies, directness of measures, and precision of estimates. We gave an SOE rating for the direction of effect in most cases.
Effect-size estimates using Cohen’s d (in standard deviation units with the associated 95% confidence interval) for every outcome for which sufficient data were available to perform a meta-analysis. Negative numbers favor meditation; positive numbers favor the control.

Abbreviations: CAD = coronary artery disease; CHF = congestive heart failure; KQ = Key Question; MA = meta-analysis; PA = primary analysis; PO = number of trials in which this was a primary outcome for the trial; SOE = strength of evidence; TM = transcendental meditation

* Summary effect size not shown due to concern about publication bias for this outcome.
**Negative affect combines the outcomes of anxiety, depression, and stress/distress, and is thus duplicative of those outcomes.
***We did not perform meta-analysis on this outcome, since it would duplicate the anxiety meta-analysis for mantra. Two additional trials could be added (on depression) but did not have usable data that could be added to the anxiety meta-analysis. Anxiety and depression are indirect measures of negative affect, and therefore resulted in a lower strength of evidence than for the outcome of mantra on anxiety.

Anxiety (KQ1) Mindfulness Various ↑ (0% to +44%) 7 [3]: 6 (6);
N = 558
Moderate for ↑ -0.40 (-0.71, -0.08)
Mantra Various Ø (−3% to +6%) 3 [2]: 3 (3);
N = 237
Low for Ø -0.22 (-.49, +.04)
Depression (KQ1) Mindfulness Various ↑ (0% to +52%) 9 [4]: 8 (8);
N = 768
Moderate for ↑ -.32 (-.66, +.01)
Mantra Various ↑↓ (−19% to +46%) 4 [1]: 4 (2);
N = 420
Insufficient -.24 (-.70, +.21)
Stress/Distress (KQ1) Mindfulness Various ↑ (+1% to +21%) 8 [3]: 6 (6*);
N = 697
Low for ↑
Mantra Selected Ø (−6% to +1%) 3 [1]: 3 (2);
N = 219
Low for Ø -.26 (-.55, +.04)
Negative Affect (KQ1) Mindfulness Various ↑ (0% to +44%) 13 [5]:11 (11**);
N = 1,102
Low for ↑ -.34 (-.53, -.14)
Mantra Various ↑↓ (−3% to +46%) 5 [2]: 5 (0***);
N = 438
Insufficient
Positive Affect (KQ1) Mindfulness Various ↑ (+1% to +55%) 3 [0]: 3 (3); N = 255 Insufficient -.31 (-.71, +.09)
TM (mantra) CHF Ø (+2%) 1 [0]: 1 (0);
N = 23
Insufficient
Quality of Life (KQ1) Mindfulness Various ↑ (+5% to +28%) 4 [2]: 4 (3);
N = 346
Low for ↑ -.28 (-.62, +.06)
Attention (KQ2) Mindfulness Caregivers ↑ (+15% to +81%) 1 [0]: 1 (0);
N = 21
Insufficient
Sleep (KQ3) Mindfulness Various ↑↓ (−3% to +24%) 4 [1]: 3 (3);
N = 451
Insufficient -.12 (-.37, +.14)
Substance Use (KQ3) TM (mantra) CAD Ø 1 [2]: 0 (0);
N = 201
Insufficient
Pain (KQ4) Mindfulness Selected ↑ (+5% to +31%) 4 [2]: 4 (4);
N = 341
Moderate for ↑ -.33 (-.62, -.03)
TM (mantra) CHF Ø (−2%) 1 [2]: 1 (0);
N = 23
Low for Ø
Weight (KQ4) TM (mantra) Selected Ø (−1% to +2%) 3 [0]: 2 (0);
N = 297
Low for Ø
Table C. Summary across measurement domains of comparisons of meditation with specific active controls
Outcome Meditation Program Population Directiona
(Magnitudeb) of Effect
Number of Trials—
Total [PO]: PA (MA);c Total N
SOEd Effect-size Estimates Using Cohen’s de
a This is the direction of change in the outcome across trials based on the relative difference between groups in how the outcome measure changed from baseline in each trial. We calculate it as the difference between the change over time in the meditation group and the change over time in the control group, divided by the baseline mean for the meditation group.

  • ↑ indicates that the meditation group improved relative to the control group (with a relative difference generally greater than or equal to 5% across trials).
  • ↓ indicates the meditation group worsened relative to the control group (with a relative difference generally greater than or equal to 5% across trials).
  • Ø indicates a null effect (with a relative difference generally less than 5% across trials).
  • ↑↓ indicates inconsistent findings. Some trials reported improvement with meditation relative to control, while others showed no improvement or improvement in the control group relative to meditation.

This is the range of estimates across all trials in a particular domain based on the relative difference between groups in how the outcome measure changed from baseline in each trial. It is a relative percentage difference calculated as: {# (Meditation T2 – Meditation T1) – (Control T2 – Control T1)}/ (Meditation T1), where T1 = baseline mean and T2 = followup mean (after intervention or at the end of the study). This is a simple range of estimates, not a meta-analysis.
c This is the number of trials that measured the outcome: primary outcome (PO), the number of trials for which this outcome was a primary outcome; primary analysis (PA), the number of trials that reported information that allowed us to calculate the relative difference between groups in the change score; and meta analysis (MA), the number of trials reporting sufficient information to be included in a meta-analysis. N refers to total sample size.
d We based SOE on the aggregate risk of bias, consistency across studies, directness of measures, and precision of estimates. We gave an SOE rating for the direction of effect in most cases.
e Effect-size estimates using Cohen’s d (in standard deviation units with the associated 95% confidence interval) for every outcome for which sufficient data were available to perform a meta-analysis. Negative numbers favor meditation; positive numbers favor the control.

Abbreviations: CSM = Clinically Standardized Meditation, a mantra meditation program; KQ = Key Question; MA = meta-analysis; PA = Primary Analysis; PO = Number of trials in which this was a primary outcome for the trial; SOE = strength of evidence

* Summary effect size not shown due to concern about publication bias for this outcome.
**Negative affect combines the outcomes of anxiety, depression, and stress/distress, and is thus duplicative of those outcomes.
***We did not perform meta-analysis on this outcome, since it would duplicate the anxiety meta-analysis for mantra. Two additional trials could be added (on depression) but did not have usable data that could be added to the anxiety meta-analysis. Anxiety and depression are indirect measures of negative affect, and therefore resulted in a lower strength of evidence than for the outcome of mantra on anxiety.

Anxiety (KQ1) Mindfulness Various ↑↓ (−39% to +8%) 9 [5]: 9 (8);
N = 526
Insufficient +0.06 (-.20, +.32)
CSM (mantra) Anxiety ↓ (−6%) 1 [1]: 1 (0);
N = 42
Insufficient
Depression (KQ1) Mindfulness Various ↑↓ (−32% to +23%) 11 [5]:11 (9);
N = 821
Insufficient -.16 (-.36, +.03)
CSM (mantra) Anxiety ↓ (−28%) 1 [1]: 1 (0);
N = 42
Insufficient
Stress/Distress (KQ1) Mindfulness Various ↑↓ (−24% to +18%) 6 [4]: 6 (6);
N = 508
Insufficient -.03 (-.23, +.17)
Positive Affect (KQ1) Mindfulness Various ↑↓ (−45% to +10%) 4 [2]: 4 (4);
N = 297
Insufficient +.04 (-.24, +.33)
Quality of Life (KQ1) Mindfulness Various ↑↓ (−23% to +9%) 6 [1]: 6 (5);
N = 472
Insufficient -.05 (-.24, +.13)
Sleep (KQ3) Mindfulness Various ↑↓ (−2% to +15%) 3 [1]: 3 (2);
N = 311
Insufficient +.14 (-.09, +.37)
Eating (KQ3) Mindfulness Selected ↓ (−6% to −15%) 2 [1]: 2 (0);
N = 158
Insufficient
Smoking/Alcohol (KQ3) Mindfulness Substance abuse ↑ (Ø to +21%) 2 [2]: 1 (0);
N = 95
Insufficient
Alcohol Only (KQ3) Mantra Alcohol abuse Ø (−5% to −36%) 2 [2]: 2 (0);
N = 145
Low for Ø
Pain (KQ4) Mindfulness Selected Ø (−1% to −32%) 4 [2]: 4 (4);
N = 410
Low for Ø +.06 (-.13, +.26)
Weight (KQ4) Mindfulness Selected Ø (−2% to +1%) 2 [2]: 2 (0);
N = 151
Low for Ø

Assessment of Potential Publication Bias

We could not conduct any reliable quantitative tests for publication bias since few studies were available for most outcomes, and we were unable to include all eligible studies in the meta-analysis due to missing data. Consequently, funnel plots were unlikely to provide much useful information regarding the possibility of publication bias. We reviewed the clinicaltrials.gov registration database to assess the number of trials that had been completed 3 or more years ago and that prespecified our outcomes but did not publish at all, or published but did not publish all outcomes that were prespecified. We found five trials on clinicaltrials.gov that appeared to have been completed before January 1, 2010, and were published but did not publish the results of all outcomes they had prespecified on the registration Web site. We also found nine trials that appeared to have been completed before January 1, 2010, and had prespecified at least one of our outcomes but for which we could not find any publication. Ten registered trials had prespecified one or more KQ1 outcomes but did not publish them, two registered trials had prespecified attention as an outcome but did not publish, five registered trials prespecified one or more KQ3 outcomes but did not publish, and five registered trials prespecified one or more KQ4 outcomes but did not publish. It was not possible to determine whether eight of the nine registered trials for which we could not find a publication had actually been conducted or completed. Among 109 outcomes in 41 trials, trials did not give enough information to calculate a relative difference-in-change score (our primary analysis) for 6 outcomes due to statistically insignificant findings. Trials did not give enough information to conduct a meta-analysis on 16 outcomes. Our findings from the primary analysis are therefore less likely to be affected by publication bias than those from the meta-analysis.

Discussion

Forty-one RCTs included in this review tested the effects of meditation programs in clinical conditions relative to active controls. Ten programs tested mantra meditation, and 31 programs tested mindfulness meditation. Active control groups included nonspecific controls, as well as specific controls that offer an opportunity to examine the comparative effectiveness of meditation programs.

Our review finds that the mantra meditation programs do not appear to improve any of the outcomes we examined, but the strength of this evidence varies from low to insufficient. We find that, compared with nonspecific active controls, the mindfulness meditation programs show small improvements in anxiety, depression, and pain with moderate SOE, and small improvements in stress/distress, negative affect, and the mental health component of health-related quality of life with low SOE. The remaining outcomes had insufficient SOE to draw any level of conclusion for mindfulness meditation programs. We were unable to draw a high-grade SOE for either type of meditation program for any of the psychological stress and well-being outcomes. We also found no evidence for any harms, although few trials reported on this.

We found 32 trials for KQ1: 4 evaluating TM, 2 evaluating other mantra meditation, and 26 evaluating mindfulness meditation. In general, we found no evidence that mantra meditation programs improve psychological stress and well-being. Compared with a nonspecific active control, mindfulness meditation programs improve multiple dimensions of negative affect, including anxiety, depression, and perceived stress/general distress, and the mental health component of quality of life, with a low to moderate SOE. Well-being and positive mood are positive dimensions of mental health. While meditation programs generally seek to improve the positive dimensions of health, the available evidence from a very small number of studies did not show any effects on positive affect or well-being. Both analytic methods—the difference-in-change estimates (which accounted for baseline differences between groups) and the meta-analyses (which compared only end-line differences)—generally showed consistent but small effects for anxiety, depression, and stress/distress. However, there are a number of observations that help in interpreting and giving context to our conclusions.

First, very few mantra meditation programs were included in our review, significantly limiting our ability to draw inferences about the effects of mantra meditation programs on psychological stress-related outcomes. These conclusions did not change when we evaluated TM separately from other mantra meditation programs. Apart from the paucity of trials, another reason for seeing null results may be the type of populations studied; for example, three TM trials enrolled cardiac patients, while only one enrolled anxiety patients. In addition, it is not known whether these study participants had high levels of a particular negative affect to begin with.

Second, among mindfulness trials, the effects were significant for anxiety and marginally significant for depression at the end of treatment, and these effects continued to be significant at 3–6 months for both anxiety and depression.

Third, when we combine each outcome that is a subdomain of negative affect (anxiety, depression, and stress/distress), we see a small and consistent signal that any domain of negative affect is improved in mindfulness programs when compared with a nonspecific active control.

Fourth, the effect sizes are small. Over the course of 2–6 months, mindfulness meditation program effect-size estimates ranged from 0.22 to 0.40 for anxiety symptoms and 0.23 to 0.32 for depressive symptoms, and were statistically significant.

Fifth, there may be differences between trials for which these outcomes are a primary versus secondary focus, although we did not find any evidence for this. Some trials that had an outcome as a primary focus did not recruit based on high symptom levels of that outcome. Thus, the samples included in these trials more closely resemble a general primary care population, and there may not be room to measure an effect if symptom levels were low to start with (i.e., a “floor” effect).

Sixth, studies found an improvement in outcomes among the mindfulness groups (compared with control) only when they made comparisons against a nonspecific active control. In each comparison against a known treatment or therapy, mindfulness did not outperform the control for any outcome. This was true for all comparisons for any form of meditation for any KQ. Out of 53 comparisons with a specific active control, we found only 2 that showed a statistically significant improvement: mindfulness-based cognitive therapy improved quality of life in comparison with use of antidepressant drugs among depressed patients, and mindfulness therapy reduced cigarette consumption in comparison with the Freedom from Smoking program. However, we also found five comparisons for which the specific active control performed better, with statistically significant results, than the meditation programs. The comparisons with specific therapies led to highly inconsistent results for most outcomes (Figure B2) and indicated that meditative therapies were no better than the specific therapies they were being compared with. These include such therapies as exercise, yoga, progressive muscle relaxation, cognitive behavioral therapy, and medications.

One RCT compared a meditation program with active control on the outcome of attention. There were no statistically significant differences between groups on the Attentional Network Test. Trends suggested that the meditation program performed better than the nonspecific active control on this measure, although the difference did not reach statistical significance. These findings indicate the need for more comprehensive trials with a variety of clinical populations (e.g., people with disorders in which attention may be compromised) to provide a clearer understanding of the impact of meditation programs on attention.

Among the 13 trials evaluating the effects of meditation programs on health-related behaviors affected by stress, 4 evaluated the effect of meditation on substance use,33,34,54,67 2 evaluated eating,43,50 and 7 evaluated sleep.31,41,42,49,55,61,70 Overall, there is insufficient evidence to indicate that meditation programs alter health-related behaviors affected by stress. Our findings are consistent with those of previous reviews in this area, in which uncontrolled studies have usually found a benefit for the effects of meditation programs on health-related behaviors affected by stress, while very few controlled studies have found a similar benefit.14-16

Among the 14 RCTs evaluating the effect on pain and weight, we found moderate SOE that MBSR reduces pain severity to a small degree when compared with a nonspecific active control. This finding is based on four trials, of which two were conducted in musculoskeletal pain patients, one in patients with irritable bowel syndrome, and one in a nonpain population. Visceral pain had a large and statistically significant relative 30-percent improvement in pain severity, while musculoskeletal pain showed 5- to 8-percent improvements that were considered nonsignificant. We also found low SOE that MBSR was not superior in reducing pain severity when compared with various specific active controls (including massage). Two mindfulness trials evaluated weight as an outcome, and it was a primary outcome for both. Three TM trials evaluated weight as a secondary outcome. Due to consistently null results, there was low SOE to suggest that TM and MBSR do not have an effect on weight.

The comparative effectiveness of an intervention obviously depends heavily on what is done for the comparison group. A strength of our review is our focus on RCTs with nonspecific active controls, which should give us greater confidence that the reported benefits are not due to having a flawed comparison group that does not control for nonspecific effects, as seen in trials using a wait-list or usual-care control.

Limitations of the Primary Studies

Although we collected information on amount of training provided, the trials did not provide enough information to make use of the data. We could not draw definitive conclusions about effect modifiers, such as dose and duration, because of the limited amount of data.

It may be that specific outcome measurement scales may be more relevant for a particular form of meditation than for others. Many studies assessed only certain measures, and the scales may have been limited in their ability to detect an effect.

We intended to evaluate the effects of meditation programs on a broad range of medical and psychiatric conditions, since psychological stress outcomes are not limited to any particular medical or psychiatric condition. Despite our focus on active RCTs, we were unable to detect a specific effect of meditation on most outcomes, with the majority of our evidence grades being insufficient or low. This was mostly driven by two important evaluation criteria: risk of bias and inconsistencies in the body of evidence. The reasons for such inconsistencies may include differences in the particular clinical conditions, as well as the type of control groups that studies used. We could not easily compare studies in which a meditation program was compared with a specific active control versus trials that used a nonspecific active control. We therefore separated these comparisons in order to be able to evaluate the effects against a relatively homogeneous nonspecific active control group. In general, comparing trials that used one specific active control with trials that used another specific active control led to large inconsistencies that could be explained by differences in the control groups.

Another possibility is that programs had no real effect on many of the outcomes that had inconsistent findings. While some of the outcomes were primary outcomes, many were secondary outcomes, and the studies may not have been appropriately powered to detect changes in secondary outcomes.

Limitations of the Review

Our assessment of a 5-percent relative difference between groups in change scores as being potentially clinically significant needs to be interpreted in the context of heterogeneous scales reporting on various measures. The literature does not clearly define the appropriate threshold for what is clinically significant on many of these scales. Some may consider a higher threshold as being clinically relevant.

While this review sought to assess the effectiveness of meditation programs above and beyond the nonspecific effects of expectation and attention, it did not assess the preferences of patients. Even though one therapy may not be better than another, many patients may still prefer it for personal or philosophical reasons.

We were limited in our ability to determine the overall applicability of the body of evidence to the broad population of patients who could benefit from mindfulness meditation because the studies varied so much in many ways other than just the specific targeted population; that is, they also varied in characteristics of the intervention, comparator, outcomes, timing, and setting. Also, the studies generally did not provide enough information to be able to determine whether the effectiveness of mindfulness meditation varied by race, ethnicity, or education.

Future Directions

Further research in meditation would benefit by addressing several remaining methodological and conceptual issues. First, all forms of meditation, including both mindfulness and mantra, imply that more time spent meditating will yield larger effects. Most forms, but not all, also present meditation as a skill that requires expert instruction and time dedicated to practice. Thus, more training with an expert and practice in daily life should lead to greater competency in the skill or practice, and greater competency or practice would presumably lead to better outcomes. When compared with other skills that require training, the amount of training afforded in the trials included in our review was quite small, and generally the training was offered over a fairly short period of time. Researchers should account for or consider the level of skill in meditation and how variation in skill may affect the effectiveness of meditation when designing studies, collecting data, and interpreting data. To facilitate this, better measurement tools are needed. Research has not adequately validated currently available mindfulness scales, and the scales do not appear to distinguish between different forms of meditation.26 Thus, we need further work on the operationalization and measurement of the particular meditative skill. For meditation programs that do not consider themselves to be training students in a skill, such as TM and certain mindfulness programs, there is still a need to transparently assess whether a student has attained a certain mental state or is correctly executing the recommended mental activities (or absence of activities).

Second, trials need to document the amount of training instructors provide and patients receive, along with the amount of home practice patients complete. This information gives an indication of how effective the program is at delivering training and how adherent participants were. This will allow us to address questions around “dosing.”

Third, studies should report on teacher qualifications in detail. The range of experience in meditation and competence as a teacher of the skill or practice likely plays a role in outcomes.

Fourth, when using a specific active control, if one finds no statistically significant superiority over the control, one is left with the issue of whether the meditation is equivalent to or not inferior to the control, or whether the trial was just underpowered to detect any difference. Conducting comparative effectiveness trials requires prior specification of the hypothesis (superiority, equivalence, noninferiority) and appropriate determination of the margins of clinical significance and minimum importance difference.72 In the case of equivalence and noninferiority, trials also need to have appropriate assay sensitivity. None of the trials showed statistically significant effects against a specific active control, nor did they appear adequately powered to assess noninferiority or equivalence. These issues leave a lot of uncertainty in such trial designs.

Fifth, positive outcomes are a key focus of meditative practices. However, most trials did not include positive outcomes as primary or even secondary outcomes. Future studies should expand on these domains.

Sixth, we were unable to review biological markers of stress for meditation programs. A comprehensive review would benefit meditation research and also allow for a cross-validation of psychological and biological outcomes.

Future trials should appropriately report key design characteristics so we can accurately assess risk of bias. Future trials should register the trial on a national register, standardize training using trainers who meet specified criteria, specify primary and secondary outcomes a priori, power the trial based on the primary outcomes, use CONSORT (CONsolidated Standards of Reporting Trials) recommendations for reporting results, and operationalize and measure the practice of meditation by study participants.

Conclusions

Our review found moderate SOE that mindfulness meditation programs are beneficial for reducing anxiety, depression, and pain severity, and low SOE that they may lead to improvement in any dimension of negative affect when compared with nonspecific active controls. There was no advantage of meditation programs over specific therapies they were compared with. Otherwise, much of the evidence was insufficient to address the comparisons for most of the questions.

There are reasons why a large number of outcomes lacked sufficient evidence. While we sought to review the highest standards of behavioral RCTs that controlled for nonspecific factors, there was wide variation in risk of bias among these trials. Another reason for a lack of sufficient evidence is that we found a limited number of trials for most outcomes, resulting in limited data available for meta-analysis or descriptive synthesis. For example, there were so few trials of TM that we could not draw meaningful conclusions from them. In addition, the reasons for a lack of significant reduction of stress-related outcomes may be related to the way the research community conceptualizes meditation programs, the difficulties of acquiring meditation skills or meditative states, and the limited duration of RCTs. Historically, the general public has not conceptualized meditation as a quick fix toward anything. It is a skill or state one learns and practices over time to increase one’s awareness, and through this awareness gain insight and understanding into the various subtleties of one’s existence. Training the mind in awareness, nonjudgmentalness, and the ability to become completely free of thoughts or other activity are daunting accomplishments. While some meditators may feel these tasks are easy, they likely overestimate their own skills due to a lack of awareness of the different degrees to which these tasks can be done or the ability to objectively measure their own progress. Since becoming an expert at simple skills such as swimming, reading, or writing (which can be objectively measured by others) takes a considerable amount of time, it follows that meditation would also take a long period of time to master. However many of the studies included in this review were short term (e.g., 2.5 hours a week for 8 weeks), and the participants likely did not achieve a level of expertise needed to improve outcomes that depend on a mastery of mental and emotional processes. The short-term nature of the studies, combined with the lack of an adequate way to measure meditation competency, could have significantly contributed to results.

Posted in News & updates | Leave a comment

Mental Health Medications

Overview

Medications can play a role in treating several mental disorders and conditions. Treatment may also include psychotherapy (also called “talk therapy”) and brain stimulation therapies (less common). In some cases, psychotherapy alone may be the best treatment option. Choosing the right treatment plan should be based on a person’s individual needs and medical situation, and under a mental health professional’s care.

The National Institute of Mental Health (NIMH), a Federal research agency, does not provide medical advice or referrals. Resources that may help you find treatment services in your area are listed on ourHelp for Mental Illnesses web page.

NIMH also does not endorse or recommend any particular drug, herb, or supplement. Results from NIMH-supported clinical research trials (What are Clinical Research Trials?) that examine the effectiveness of treatments, including medications, are reported in the medical literature. This health topic webpage is intended to provide basic information about mental health medications. It is not a complete source for all medications available and should not be used as a guide for making medical decisions.

Information about medications changes frequently. Check the U.S. Food and Drug Administration (FDA) website  for the latest warnings, patient medication guides, or newly approved medications. Brand names are not referenced on this page, but you can search by brand name on MedlinePlus Drugs, Herbs and Supplements Drugs website. The MedlinePlus website also provides additional information about each medication, including side effects and FDA warnings.

Understanding Your Medications

If you are prescribed a medication, be sure that you:

  • Tell the doctor about all medications and vitamin supplements you are already taking.
  • Remind your doctor about any allergies and any problems you have had with medicines.
  • Understand how to take the medicine before you start using it and take your medicine as instructed.
  • Don’t take medicines prescribed for another person or give yours to someone else.
  • Call your doctor right away if you have any problems with your medicine or if you are worried that it might be doing more harm than good. Your doctor may be able to adjust the dose or change your prescription to a different one that may work better for you.
  • Report serious side effects to the FDA MedWatch Adverse Event Reporting program online at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088]. You or your doctor may send a report.

Antidepressants

What are antidepressants?

Antidepressants are medications commonly used to treat depression. Antidepressants are also used for other health conditions, such as anxiety, pain and insomnia. Although antidepressants are not FDA-approved specifically to treat ADHD, antidepressants are sometimes used to treat ADHD in adults.

The most popular types of antidepressants are called selective serotonin reuptake inhibitors (SSRIs). Examples of SSRIs include:

Other types of antidepressants are serotonin and norepinephrine reuptake inhibitors (SNRIs). SNRIs are similar to SSRIs and includevenlafaxine  and duloxetine. 

Another antidepressant that is commonly used is bupropion.Bupropion  is a third type of antidepressant which works differently than either SSRIs or SNRIs.  Bupropion is also used to treat seasonal affective disorder and to help people stop smoking.

SSRIs, SNRIs, and bupropion are popular because they do not cause as many side effects as older classes of antidepressants, and seem to help a broader group of depressive and anxiety disorders. Older antidepressant medications include tricyclics, tetracyclics, and monoamine oxidase inhibitors (MAOIs). For some people, tricyclics, tetracyclics, or MAOIs may be the best medications.

How do people respond to antidepressants?

According to a research review by the Agency for Healthcare Research and Quality , all antidepressant medications work about as well as each other to improve symptoms of depression and to keep depression symptoms from coming back. For reasons not yet well understood, some people respond better to some antidepressant medications than to others.

Therefore, it is important to know that some people may not feel better with the first medicine they try and may need to try several medicines to find the one that works for them. Others may find that a medicine helped for a while, but their symptoms came back. It is important to carefully follow your doctor’s directions for taking your medicine at an adequate dose and over an extended period of time (often 4 to 6 weeks) for it to work.

Once a person begins taking antidepressants, it is important to not stop taking them without the help of a doctor. Sometimes people taking antidepressants feel better and stop taking the medication too soon, and the depression may return. When it is time to stop the medication, the doctor will help the person slowly and safely decrease the dose. It’s important to give the body time to adjust to the change. People don’t get addicted (or “hooked”) on these medications, but stopping them abruptly may also cause withdrawal symptoms

What are the possible side effects of antidepressants?

Some antidepressants may cause more side effects than others. You may need to try several different antidepressant medications before finding the one that improves your symptoms and that causes side effects that you can manage.

The most common side effects listed by the FDA include:

  • Nausea and vomiting
  • Weight gain
  • Diarrhea
  • Sleepiness
  • Sexual problems

Call your doctor right away if you have any of the following symptoms, especially if they are new, worsening, or worry you(U.S. Food and Drug Administration, 2011):

  • Thoughts about suicide or dying
  • Attempts to commit suicide
  • New or worsening depression
  • New or worsening anxiety
  • Feeling very agitated or restless
  • Panic attacks
  • Trouble sleeping (insomnia)
  • New or worsening irritability
  • Acting aggressively, being angry, or violent
  • Acting on dangerous impulses
  • An extreme increase in activity and talking (mania)
  • Other unusual changes in behavior or mood

Combining the newer SSRI or SNRI antidepressants with one of the commonly-used “triptan” medications used to treat migraine headaches could cause a life-threatening illness called “serotonin syndrome.” A person with serotonin syndrome may be agitated, have hallucinations (see or hear things that are not real), have a high temperature, or have unusual blood pressure changes. Serotonin syndrome is usually associated with the older antidepressants called MAOIs, but it can happen with the newer antidepressants as well, if they are mixed with the wrong medications. For more information, please see the FDA Medication Guide on Antidepressant Medicines 

Antidepressants may cause other side effects that were not included in this list. To report any serious adverse effects associated with the use of antidepressant medicines, please contact the FDA MedWatch program using the contact information at the bottom of this page. For more information about the risks and side effects for each medication, please see Drugs@FDA .

Anti-Anxiety Medications

What are anti-anxiety medications?

Anti-anxiety medications help reduce the symptoms of anxiety, such as panic attacks, or extreme fear and worry. The most common anti-anxiety medications are called benzodiazepines. Benzodiazepines can treat generalized anxiety disorder. In the case of panic disorder or social phobia (social anxiety disorder), benzodiazepines are usually second-line treatments, behind SSRIs or other antidepressants.

Benzodiazepines used to treat anxiety disorders include:

Short half-life (or short-acting) benzodiazepines (such as Lorazepam ) and beta-blockers are used to treat the short-term symptoms of anxiety. Beta-blockers help manage physical symptoms of anxiety, such as trembling, rapid heartbeat, and sweating that people with phobias (an overwhelming and unreasonable fear of an object or situation, such as public speaking) experience in difficult situations. Taking these medications for a short period of time can help the person keep physical symptoms under control and can be used “as needed” to reduce acute anxiety.Buspirone  (which is unrelated to the benzodiazepines) is sometimes used for the long-term treatment of chronic anxiety. In contrast to the benzodiazepines, buspirone must be taken every day for a few weeks to reach its full effect. It is not useful on an “as-needed” basis.

How do people respond to anti-anxiety medications?

Anti-anxiety medications such as benzodiazepines are effective in relieving anxiety and take effect more quickly than the antidepressant medications (or buspirone) often prescribed for anxiety. However, people can build up a tolerance to benzodiazepines if they are taken over a long period of time and may need higher and higher doses to get the same effect. Some people may even become dependent on them. To avoid these problems, doctors usually prescribe benzodiazepines for short periods, a practice that is especially helpful for older adults (read the NIMH article: Despite Risks, Benzodiazepine Use Highest in Older People), people who have substance abuse problems and people who become dependent on medication easily. If people suddenly stop taking benzodiazepines, they may have withdrawal symptoms or their anxiety may return. Therefore, benzodiazepines should be tapered off slowly.

What are the possible side effects of anti-anxiety medications?

Like other medications, anti-anxiety medications may cause side effects. Some of these side effects and risks are serious. The most common side effects for benzodiazepines are drowsiness and dizziness. Other possible side effects include:

  • Nausea
  • Blurred vision
  • Headache
  • Confusion
  • Tiredness
  • Nightmares

Tell your doctor if any of these symptoms are severe or do not go away:

  • Drowsiness
  • Dizziness
  • Unsteadiness
  • Problems with coordination
  • Difficulty thinking or remembering
  • Increased saliva
  • Muscle or joint pain
  • Frequent urination
  • Blurred vision
  • Changes in sex drive or ability (The American Society of Health-System Pharmacists, Inc, 2010)

If you experience any of the symptoms below, call your doctor immediately:

  • Rash
  • Hives
  • Swelling of the eyes, face, lips, tongue, or throat
  • Difficulty breathing or swallowing
  • Hoarseness
  • Seizures
  • Yellowing of the skin or eyes
  • Depression
  • Difficulty speaking
  • Yellowing of the skin or eyes
  • Thoughts of suicide or harming yourself
  • Difficulty breathing

Common side effects of beta-blockers include:

  • Fatigue
  • Cold hands
  • Dizziness or light-headedness
  • Weakness

Beta-blockers generally are not recommended for people with asthma or diabetes because they may worsen symptoms related to both.

Possible side effects from buspirone include:

  • Dizziness
  • Headaches
  • Nausea
  • Nervousness
  • Lightheadedness
  • Excitement
  • Trouble sleeping

Anti-anxiety medications may cause other side effects that are not included in the lists above. To report any serious adverse effects associated with the use of these medicines, please contact the FDA MedWatch program using the contact information at the bottom of this page. For more information about the risks and side effects for each medication, please see Drugs@FDA. 

Stimulants

What are Stimulants?

As the name suggests, stimulants increase alertness, attention, and energy, as well as elevate blood pressure, heart rate, and respiration (National Institute on Drug Abuse, 2014). Stimulant medications are often prescribed to treat children, adolescents, or adults diagnosed with ADHD.

Stimulants used to treat ADHD include:

Note: In 2002, the FDA approved the non-stimulant medication atomoxetine for use as a treatment for ADHD. Two other non-stimulant antihypertensive medications, clonidine  and guanfacine , are also approved for treatment of ADHD in children and adolescents. One of these non-stimulant medications is often tried first in a young person with ADHD, and if response is insufficient, then a stimulant is prescribed.

Stimulants are also prescribed to treat other health conditions, including narcolepsy, and occasionally depression (especially in older or chronically medically ill people and in those who have not responded to other treatments).

How do people respond to stimulants?

Prescription stimulants have a calming and “focusing” effect on individuals with ADHD. Stimulant medications are safe when given under a doctor’s supervision. Some children taking them may feel slightly different or “funny.”

Some parents worry that stimulant medications may lead to drug abuse or dependence, but there is little evidence of this when they are used properly as prescribed. Additionally, research shows that teens with ADHD who took stimulant medications were less likely to abuse drugs than those who did not take stimulant medications.

What are the possible side effects of stimulants?

Stimulants may cause side effects. Most side effects are minor and disappear when dosage levels are lowered. The most common side effects include:

  • Difficulty falling asleep or staying asleep
  • Loss of appetite
  • Stomach pain
  • Headache

Less common side effects include:

  • Motor tics or verbal tics (sudden, repetitive movements or sounds)
  • Personality changes, such as appearing “flat” or without emotion

Call your doctor right away if you have any of these symptoms, especially if they are new, become worse, or worry you.

Stimulants may cause other side effects that are not included in the list above. To report any serious adverse effects associated with the use of stimulants, please contact the FDA MedWatch program using the contact information at the bottom of this page. For more information about the risks and side effects for each medication, please seeDrugs@FDA. 

Antipsychotics

What are antipsychotics?

Antipsychotic medicines are primarily used to manage psychosis. The word “psychosis” is used to describe conditions that affect the mind, and in which there has been some loss of contact with reality, often including delusions (false, fixed beliefs) or hallucinations (hearing or seeing things that are not really there). It can be a symptom of a physical condition such as drug abuse or a mental disorder such as schizophrenia, bipolar disorder, or very severe depression (also known as “psychotic depression”).

Antipsychotic medications are often used in combination with other medications to treat delirium, dementia, and mental health conditions, including:

Antipsychotic medicines do not cure these conditions. They are used to help relieve symptoms and improve quality of life.

Older or first-generation antipsychotic medications are also called conventional “typical” antipsychotics or “neuroleptics”. Some of the common typical antipsychotics include:

Newer or second generation medications are also called “atypical” antipsychotics. Some of the common atypical antipsychotics include:

According to a 2013 research review by the Agency for Healthcare Research and Quality , typical and atypical antipsychotics both work to treat symptoms of schizophrenia and the manic phase of bipolar disorder.

Several atypical antipsychotics have a “broader spectrum” of action than the older medications, and are used for treating bipolar depression or depression that has not responded to an antidepressant medication alone.

To find additional antipsychotics and other medications used to manage psychoses and current warnings and advisories, please visit the FDA website .

How do people respond to antipsychotics?

Certain symptoms, such as feeling agitated and having hallucinations, usually go away within days of starting an antipsychotic medication. Symptoms like delusions usually go away within a few weeks, but the full effects of the medication may not be seen for up to six weeks. Every patient responds differently, so it may take several trials of different antipsychotic medications to find the one that works best.

Some people may have a relapse—meaning their symptoms come back or get worse. Usually relapses happen when people stop taking their medication, or when they only take it sometimes. Some people stop taking the medication because they feel better or they may feel that they don’t need it anymore, but no one should stop taking an antipsychotic medication without talking to his or her doctor.When a doctor says it is okay to stop taking a medication, it should be gradually tapered off— never stopped suddenly. Many people must stay on an antipsychotic continuously for months or years in order to stay well; treatment should be personalized for each individual.

What are the possible side effects of antipsychotics?

Antipsychotics have many side effects (or adverse events) and risks. The FDA lists the following side effects of antipsychotic medicines:

  • Drowsiness
  • Dizziness
  • Restlessness
  • Weight gain (the risk is higher with some atypical antipsychotic medicines)
  • Dry mouth
  • Constipation
  • Nausea
  • Vomiting
  • Blurred vision
  • Low blood pressure
  • Uncontrollable movements, such as tics and tremors (the risk is higher with typical antipsychotic medicines)
  • Seizures
  • A low number of white blood cells, which fight infections

A person taking an atypical antipsychotic medication should have his or her weight, glucose levels, and lipid levels monitored regularly by a doctor.

Typical antipsychotic medications can also cause additional side effects related to physical movement, such as:

  • Rigidity
  • Persistent muscle spasms
  • Tremors
  • Restlessness

Long-term use of typical antipsychotic medications may lead to a condition called tardive dyskinesia (TD). TD causes muscle movements, commonly around the mouth, that a person can’t control. TD can range from mild to severe, and in some people, the problem cannot be cured. Sometimes people with TD recover partially or fully after they stop taking typical antipsychotic medication. People who think that they might have TD should check with their doctor before stopping their medication. TD rarely occurs while taking atypical antipsychotics.

Antipsychotics may cause other side effects that are not included in this list above. To report any serious adverse effects associated with the use of these medicines, please contact the FDA MedWatch program . For more information about the risks and side effects for antipsychotic medications, please visit Drugs@FDA .

Mood Stabilizers

What are mood stabilizers?

Mood stabilizers are used primarily to treat bipolar disorder, mood swings associated with other mental disorders, and in some cases, to augment the effect of other medications used to treat depression.Lithium , which is aneffective mood stabilizer, is approved for the treatment of mania and the maintenance treatment of bipolar disorder. A number of cohort studies describe anti-suicide benefits of lithium for individuals on long-term maintenance. Mood stabilizers work by decreasing abnormal activity in the brain and are also sometimes used to treat:

  • Depression (usually along with an antidepressant)
  • Schizoaffective Disorder
  • Disorders of impulse control
  • Certain mental illnesses in children

Anticonvulsant medications are also used as mood stabilizers. They were originally developed to treat seizures, but they were found to help control unstable moods as well. One anticonvulsant commonly used as a mood stabilizer is valproic acid  (also called divalproex sodium). For some people, especially those with “mixed” symptoms of mania and depression or those with rapid-cycling bipolar disorder, valproic acid may work better than lithium. Other anticonvulsants used as mood stabilizers include:

What are the possible side effects of mood stabilizers?

Mood stabilizers can cause several side effects, and some of them may become serious, especially at excessively high blood levels. These side effects include:

  • Itching, rash
  • Excessive thirst
  • Frequent urination
  • Tremor (shakiness) of the hands
  • Nausea and vomiting
  • Slurred speech
  • Fast, slow, irregular, or pounding heartbeat
  • Blackouts
  • Changes in vision
  • Seizures
  • Hallucinations (seeing things or hearing voices that do not exist)
  • Loss of coordination
  • Swelling of the eyes, face, lips, tongue, throat, hands, feet, ankles, or lower legs.

If a person with bipolar disorder is being treated with lithium, he or she should visit the doctor regularly to check the lithium levels his or her blood, and make sure the kidneys and the thyroid are working normally.

Lithium is eliminated from the body through the kidney, so the dose may need to be lowered in older people with reduced kidney function. Also, loss of water from the body, such as through sweating or diarrhea, can cause the lithium level to rise, requiring a temporary lowering of the daily dose. Although kidney functions are checked periodically during lithium treatment, actual damage of the kidney is uncommon in people whose blood levels of lithium have stayed within the therapeutic range.

Mood stabilizers may cause other side effects that are not included in this list. To report any serious adverse effects associated with the use of these medicines, please contact the FDA MedWatch program using the contact information at the bottom of this page. For more information about the risks and side effects for each individual medication, please see Drugs@FDA .

For more information on the side effects of Carbamazepine ,Lamotrigine , and Oxcarbazepine , please visit MedlinePlus Drugs, Herbs and Supplements .

Some possible side effects linked anticonvulsants (such as valproic acid) include:

  • Drowsiness
  • Dizziness
  • Headache
  • Diarrhea
  • Constipation
  • Changes in appetite
  • Weight changes
  • Back pain
  • Agitation
  • Mood swings
  • Abnormal thinking
  • Uncontrollable shaking of a part of the body
  • Loss of coordination
  • Uncontrollable movements of the eyes
  • Blurred or double vision
  • Ringing in the ears
  • Hair loss

These medications may also:

  • Cause damage to the liver or pancreas, so people taking it should see their doctors regularly
  • Increase testosterone (a male hormone) levels in teenage girls and lead to a condition called polycystic ovarian syndrome (a disease that can affect fertility and make the menstrual cycle become irregular)

Medications for common adult health problems, such as diabetes, high blood pressure, anxiety, and depression may interact badly with anticonvulsants. In this case, a doctor can offer other medication options.

For more information about the risks and side effects for each medication, please see Drugs@FDA .

Special Groups: Children, Older Adults, Pregnant Women

All types of people take psychiatric medications, but some groups have special needs, including:

  • Children and adolescents
  • Older adults
  • Women who are pregnant or who may become pregnant

Children and Adolescents

Many medications used to treat children and adolescents with mental illness are safe and effective. However, some medications have not been studied or approved for use with children or adolescents.

Still, a doctor can give a young person an FDA-approved medication on an “off-label” basis. This means that the doctor prescribes the medication to help the patient even though the medicine is not approved for the specific mental disorder that is being treated or for use by patients under a certain age. Remember:

  • It is important to watch children and adolescents who take these medications on an “off-label: basis.
  • Children may have different reactions and side effects than adults.
  • Some medications have current FDA warnings about potentially dangerous side effects for younger patients.

In addition to medications, other treatments for children and adolescents should be considered, either to be tried first, with medication added later if necessary, or to be provided along with medication. Psychotherapy, family therapy, educational courses, and behavior management techniques can help everyone involved cope with disorders that affect a child’s mental health. Read more about child and adolescent mental health research.

Older Adults

People over 65 have to be careful when taking medications, especially when they’re taking many different drugs. Older adults have a higher risk for experiencing bad drug interactions, missing doses, or overdosing.

Older adults also tend to be more sensitive to medications. Even healthy older people react to medications differently than younger people because older people’s bodies process and eliminate medications more slowly. Therefore, lower or less frequent doses may be needed for older adults. Before starting a medication, older people and their family members should talk carefully with a physician about whether a medication can affect alertness, memory, or coordination, and how to help ensure that prescribed medications do not increase the risk of falls.

Sometimes memory problems affect older people who take medications for mental disorders. An older adult may forget his or her regular dose and take too much or not enough. A good way to keep track of medicine is to use a seven-day pill box, which can be bought at any pharmacy. At the beginning of each week, older adults and their caregivers fill the box so that it is easy to remember what medicine to take. Many pharmacies also have pill boxes with sections for medications that must be taken more than once a day.

For more information and practical tips to help older people take their medicines safely, please see National Institute on Aging’s Safe Use of Medicines booklet and Taking Medicines  on NIHSeniorHealth.gov.

Women who are pregnant or who may become pregnant

The research on the use of psychiatric medications during pregnancy is limited. The risks are different depending on which medication is taken, and at what point during the pregnancy the medication is taken. Decisions on treatments for all conditions during pregnancy should be based on each woman’s needs and circumstances, and based on a careful weighing of the likely benefits and risks of all available options, including psychotherapy (or “watchful waiting” during part or all of the pregnancy), medication, or a combination of the two. While no medication is considered perfectly safe for all women at all stages of pregnancy, this must be balanced for each woman against the fact that untreated serious mental disorders themselves can pose a risk to a pregnant woman and her developing fetus. Medications should be selected based on available scientific research, and they should be taken at the lowest possible dose. Pregnant women should have a medical professional who will watch them closely throughout their pregnancy and after delivery.

Most women should avoid certain medications during pregnancy. For example:

  • Mood stabilizers are known to cause birth defects. Benzodiazepines and lithium have been shown to cause “floppy baby syndrome,” in which a baby is drowsy and limp, and cannot breathe or feed well. Benzodiazepines may cause birth defects or other infant problems, especially if taken during the first trimester.
  • According to research, taking antipsychotic medications during pregnancy can lead to birth defects, especially if they are taken during the first trimester and in combination with other drugs, but the risks vary widely and depend on the type of antipsychotic taken. The conventional antipsychotic haloperidol has been studied more than others, and has been found not to cause birth defects. Research on the newer atypical antipsychotics is ongoing.

Antidepressants, especially SSRIs, are considered to be safe during pregnancy. However, antidepressant medications do cross the placental barrier and may reach the fetus. Birth defects or other problems are possible, but they are very rare. The effects of antidepressants on childhood development remain under study.

Studies have also found that fetuses exposed to SSRIs during the third trimester may be born with “withdrawal” symptoms such as breathing problems, jitteriness, irritability, trouble feeding, or hypoglycemia (low blood sugar). Most studies have found that these symptoms in babies are generally mild and short-lived, and no deaths have been reported. Risks from the use of antidepressants need to be balanced with the risks of stopping medication; if a mother is too depressed to care for herself and her child, both may be at risk for problems.

In 2004, the FDA issued a warning against the use of certain antidepressants in the late third trimester. The warning said that doctors may want to gradually taper pregnant women off antidepressants in the third trimester so that the baby is not affected. After a woman delivers, she should consult with her doctor to decide whether to return to a full dose during the period when she is most vulnerable to postpartum depression.

After the baby is born, women and their doctors should watch for postpartum depression, especially if a mother stopped taking her medication during pregnancy. In addition, women who nurse while taking psychiatric medications should know that a small amount of the medication passes into the breast milk. However, the medication may or may not affect the baby depending s on the medication and when it is taken. Women taking psychiatric medications and who intend to breastfeed should discuss the potential risks and benefits with their doctors.

Contact FDA MedWatch

About the FDA

The FDA is responsible for protecting the public health by ensuring the safety, efficacy and security of drugs (medications), biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

FDA is also responsible for advancing public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get accurate science-based information they need to use medicines and foods to maintain and improve their health.

Reporting Serious Problems to the FDA

Visit FDA’s MedWatch  to voluntarily report a serious adverse effect, product quality problem, product use error or product failure that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic. You can also report suspected counterfeit medical products to the FDA through MedWatch . You can also use the contact information provided below:

1-800-332-1088

1-800-FDA-0178 Fax

Report a Serious Problem: MedWatch Online 

Regular Mail: Use postage-paid FDA Form 3500 

Mail to: MedWatch, 5600 Fishers Lane, Rockville, MD 20857

Subscribe to MedWatch Safety Alerts

FDAs MedWatch program offers several ways to help you stay informed about the medical products are prescribed, administered, or dispensed every day. Get safety alerts delivered to your inbox. To subscribe, join the MedWatch email list . Learn more about the MedWatch E-list . You can also follow MedWatch on Twitter by following @FDAMedWatch .

Posted in News & updates | Leave a comment

What Are Antipsychotics?

This class of drugs is used to treat a range of mental illnesses.

Antipsychotics are a group of drugs that are used to treat schizophrenia.

The medicines are also sometimes used to treat other mental illnesses, such as bipolar disorder, severe anxiety, or depression.

Older antipsychotics (known as “typical” antipsychotics) have been around since the mid-1950s.

Newer antipsychotics (known as “atypical” antipsychotics) were developed in the 1990s.

Antipsychotics work by blocking dopamine, a substance in the brain known as a neurotransmitter.

The medicines come as tablets, capsules, liquids, and depot (long-acting) injections. They’re marketed under various brand names.

Common Antipsychotics

Some common antipsychotics include:

NexGard® (afoxolaner)
http://www.nexgardfordogs.com
The Tasty Beef-Flavored Chewable!
Ask Your Vet About NexGard Today.
Chlorpromazine (Thorazine)
Clozaril and FazaClo (clozapine)
Haloperidol
Perphenazine
Fluphenazine
Risperdal (risperidone)
Zyprexa (olanzapine)
Seroquel (quetiapine)
Geodon (ziprasidone)
Abilify (aripiprazole)
Invega (paliperidone)
Latuda (lurasidone)
Side Effects of Antipsychotics

Side effects of antipsychotics may include:

Drowsiness
Dizziness
Rapid heartbeat
Blurred vision
Constipation
Skin rash
Sensitivity to sunlight
Menstrual problems in women
Weight gain or changes in metabolism
Muscle spasms
Tremors
Restlessness
Antipsychotic Safety and Warnings

Long-term use of typical (older) antipsychotic drugs may cause a serious and sometimes incurable movement condition called tardive dyskinesia (TD).

About 5 percent of people who take antipsychotics get TD each year, according to the National Institute of Mental Health.

Antipsychotics aren’t recommended for older adults with dementia, as these drugs may put them at increased risk for stroke and death.

The antipsychotic clozapine is highly effective, but it can cause a serious decrease in the number of white blood cells, which help your body fight off infections. Talk to your doctor about this risk.
Antipsychotics may also raise your risk of developing high cholesterol and diabetes.

Tell your doctor about all medical conditions you have before taking an antipsychotic.

Also, let your doctor know about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you’re taking.

Don’t drive or perform activities that require alertness until you know how the antipsychotic you’re taking affects you.

Follow the instructions on your prescription or package label carefully. Don’t take more or less of the drug than is recommended.

Don’t stop taking an antipsychotic without first talking to your doctor. Your doctor will probably want to take you off the drug gradually.

Keep all appointments with your doctor’s office and laboratory while taking an antipsychotic.

Your doctor will probably want to perform tests frequently to monitor your body’s response to the medicine.

Let your healthcare provider know that you’re taking an antipsychotic before having any type of surgery, including a dental procedure.

Antipsychotics and Alcohol

Alcohol can increase certain side effects of antipsychotics.

Avoid drinking alcohol while taking these medicines.

Antipsychotics and Pregnancy
Tell your doctor if you’re pregnant, or might become pregnant, before taking an antipsychotic.

Some antipsychotics may be safe to take during pregnancy, but you should discuss the benefits and risks of this with your doctor.

Also, talk to your healthcare provider before taking an antipsychotic if you’re breastfeeding.

Posted in News & updates | Leave a comment

Mental Health: There’s an App for That

Smartphone apps claim to help conditions from addiction to schizophrenia, but few have been thoroughly tested

Type ‘depression’ into the Apple App Store and a list of at least a hundred programs will pop up on the screen. There are apps that diagnose depression (Depression Test), track moods (Optimism) and help people to “think more positive” (Affirmations!). There’s Depression Cure Hypnosis (“The #1 Depression Cure Hypnosis App in the App Store”), Gratitude Journal (“the easiest and most effective way to rewire your brain in just five minutes a day”), and dozens more. And that’s just for depression. There are apps pitched at people struggling with anxiety, schizophrenia, post-traumatic stress disorder (PTSD), eating disorders and addiction.

This burgeoning industry may meet an important need. Estimates suggest that about 29% of people will experience a mental disorder in their lifetime. Data from the World Health Organization (WHO) show that many of those people — up to 55% in developed countries and 85% in developing ones — are not getting the treatment they need. Mobile health apps could help to fill the gap (see ‘Mobilizing mental health’). Given the ubiquity of smartphones, apps might serve as a digital lifeline — particularly in rural and low-income regions — putting a portable therapist in every pocket. “We can now reach people that up until recently were completely unreachable to us,” says Dror Ben-Zeev, who directs the mHealth for Mental Health Program at the Dartmouth Psychiatric Research Center in Lebanon, New Hampshire.

Public-health organizations have been buying into the concept. In its Mental Health Action Plan 2013–2020, the WHO recommended “the promotion of self-care, for instance, through the use of electronic and mobile health technologies.” And the UK National Health Service (NHS) website NHS Choices carries a short list of online mental-health resources, including a few apps, that it has formally endorsed.

But the technology is moving a lot faster than the science. Although there is some evidence that empirically based, well-designed mental-health apps can improve outcomes for patients, the vast majority remain unstudied. They may or may not be effective, and some may even be harmful. Scientists and health officials are now beginning to investigate their potential benefits and pitfalls more thoroughly, but there is still a lot left to learn and little guidance for consumers.

“If you type in ‘depression’, its hard to know if the apps that you get back are high quality, if they work, if they’re even safe to use,” says John Torous, a psychiatrist at Harvard Medical School in Boston, Massachusetts, who chairs the American Psychiatric Association’s Smartphone App Evaluation Task Force. “Right now it almost feels like the Wild West of health care.”

APP HAPPY

Electronic interventions are not new to psychology; there is robust literature showing that Internet-based cognitive behavioural therapy (CBT), a therapeutic approach that aims to change problematic thoughts and behaviours, can be effective for treating conditions such as depression, anxiety and eating disorders. But many of these online therapeutic programmes are designed to be completed in lengthy sessions in front of a conventional computer screen.

Smartphone apps, on the other hand, can be used on the go. “It’s a way of people getting access to treatment that’s flexible and fits in with their lifestyle and also deals with the issues around stigma — if people are not quite ready to maybe go and see their doctor, then it might be a first step to seeking help,” says Jen Martin, the programme manager at MindTech, a national centre funded by the United Kingdom’s National Institute for Health Research and devoted to developing and testing new mental-health technologies.

One of the best-known publicly available apps was devised to meet that desire for flexibility. In 2010, US government psychologists conducting focus groups with military veterans who had PTSD learned that they wanted a tool they could use whenever their symptoms flared up. “They wanted something that they could use in the moment when the distress was rising — so when they were in line at the supermarket,” says Eric Kuhn, a clinical psychologist and the mobile apps lead at the US Department of Veterans Affairs’ National Center for PTSD.

The department joined up with the US Department of Defense to create PTSD Coach, a free smartphone app released in early 2011. Anyone who has experienced trauma can use the app to learn more about PTSD, track symptoms and set up a support network of friends and family members. The app also provides strategies for coping with overwhelming emotions; it might suggest that users distract themselves by finding a funny video on YouTube or lead users through visualization exercises.

In its first three years in app stores, PTSD Coach was downloaded more than 150,000 times in 86 different countries. It has shown promise in several small studies; in a 2014 study of 45 veterans, more than 80% reported that the app helped them to track and manage their symptoms and provided practical solutions to their problems. More results are expected soon. Kuhn and his colleagues recently completed a 120-person randomized trial of the app, and a Dutch team is currently analysing data from a 1,300-patient trial on a similar app called SUPPORT Coach.

Smartphone apps can also interact with users proactively, pinging them to ask about their moods, thoughts and overall well-being. Ben-Zeev created one called FOCUS, which is geared towards patients with schizophrenia. Several times a day, the app prompts users to answer questions such as “How well did you sleep last night?” or “How has your mood been today?” If users report that they slept poorly, or have been feeling anxious, the app will suggest strategies for tackling that problem, such as limiting caffeine intake or doing some deep-breathing exercises.

Some apps help people to stay connected to health-care professionals, too. ClinTouch, a psychiatric-symptom-assessment app designed by researchers at the University of Manchester, UK, analyses users’ responses for signs that they may be experiencing a relapse; it can even notify a clinical-care team.

Small feasibility studies — which are generally designed to determine whether an intervention is practical, but do not necessarily evaluate its efficacy — have shown that patients use and like both apps, and a 2014 study found that those who used FOCUS for a month experienced a reduction in psychotic symptoms and depression. FOCUS and ClinTouch are both now being evaluated in randomized, controlled trials.

Some researchers see opportunities in the data that smartphones collect about their users’ movement patterns or communication activity, which could provide a potential window into mental health. “Your smartphone is really this interesting diary of your life,” says Anmol Madan, the co-founder and chief executive of Ginger.io, a digital mental-health company based in San Francisco, California. Studies have now shown that certain patterns of smartphone use can predict changes in mental-health symptoms; a drop in the frequency of outgoing text messages, for instance, may suggest that a user’s depression is worsening.

The Ginger.io app, which is still in beta, monitors these sorts of patterns and alerts each user’s assigned mental-health coach if it detects a worrying change.

ABSENT EVIDENCE

The evidence supporting the use of such apps is building. But this is a science in its infancy. Much of the research has been limited to pilot studies, and randomized trials tend to be small and unreplicated. Many studies have been conducted by the apps’ own developers, rather than by independent researchers. Placebo-controlled trials are rare, raising the possibility that a ‘digital placebo effect’ may explain some of the positive outcomes that researchers have documented, says Torous. “We know that people have very strong relationships with their smartphones,” and receiving messages and advice through a familiar, personal device may be enough to make some people feel better, he explains.

But the bare fact is that most apps haven’t been tested at all. A 2013 review identified more than 1,500 depression-related apps in commercial app stores but just 32 published research papers on the subject. In another study published that year, Australian researchers applied even more stringent criteria, searching the scientific literature for papers that assessed how commercially available apps affected mental-health symptoms or disorders. They found eight papers on five different apps.

The same year, the NHS launched a library of “safe and trusted” health apps that included 14 devoted to treating depression or anxiety. But when two researchers took a close look at these apps last year, they found that only 4 of the 14 provided any evidence to support their claims. Simon Leigh, a health economist at Lifecode Solutions in Liverpool, UK, who conducted the analysis, says he wasn’t shocked by the finding because efficacy research is costly and may mean that app developers have less to spend on marketing their products.

A separate analysis found that 35 of the mobile health apps originally listed by the NHS transmitted identifying information — such as e-mail addresses, names and birthdates — about users over the Internet, and two-thirds of these did not encrypt the data.

Last year, the NHS took this apps library offline and posted a smaller collection of recommended online mental-health services. The NHS did not respond to e-mailed questions or make an official available for interview, but it did provide this statement: “We are working to upgrade the Health Apps Library, which was launched as a pilot site in 2013 to review and recommend apps against a defined set of criteria which included data protection.”

The regulation of mental-health apps is opaque. Some apps designed to be used in a medical context can be considered medical devices and therefore may be regulated by the UK Medicines and Healthcare Products Regulatory Agency, the US Food and Drug Administration (FDA) or equivalent bodies elsewhere. But the lines are fuzzy. In general, an app that claims to prevent, diagnose or treat a specific disease is likely to be considered a medical device and to attract regulatory scrutiny, whereas one that promises to ‘boost mood’ or provide ‘coaching’ might not. The FDA has said that it will regulate only those health apps that present the highest risks to patients if they work improperly; even mental-health apps that qualify as medical devices might not be regulated if the agency deems them to be relatively low risk.

But the potential risks are not well understood. “At the low end, people might waste their money or waste their time,” says Martin, “and at the higher end, especially with mental health, they might be actively harmful or giving dangerous advice or preventing people from going and getting proper treatment.”

When a team of Australian researchers reviewed 82 commercially available smartphone apps for people with bipolar disorder, they found that some presented information that was “critically wrong”. One, called iBipolar, advised people in the middle of a manic episode to drink hard liquor to help them to sleep, and another, called What is Biopolar Disorder, suggested that bipolar disorder could be contagious. Neither app seems to be available any more.

Martin says that in Europe, at least, apps tend to come in two varieties, those that are commercially developed and come with little supporting evidence or plans for evaluation, and those with academic or government backing that take a more rigorous approach. The problem is that the former are generally more engaging for users and the latter take so long to make it to the market — if they even do — that they look out of date. “This is a generalization,” Martin says, “but it’s broadly true.”

UNINTENDED CONSEQUENCES

Even well-intentioned apps can produce unpredictable outcomes. Take Promillekoll, a smartphone app created by Sweden’s government-owned liquor retailer, designed to help curb risky drinking. While out at a pub or a party, users enter each drink they consume and the app spits out an approximate blood-alcohol concentration.

When Swedish researchers tested the app on college students, they found that men who were randomly assigned to use the app ended up drinking more frequently than before, although their total alcohol consumption did not increase. “We can only speculate that app users may have felt more confident that they could rely on the app to reduce negative effects of drinking and therefore felt able to drink more often,” the researchers wrote in their 2014 paper.

It’s also possible, the scientists say, that the app spurred male students to turn drinking into a game. “I think that these apps are kind of playthings,” says Anne Berman, a clinical psychologist at the Karolinska Institute in Stockholm and one of the study’s authors. There are other risks too. In early trials of ClinTouch, researchers found that the symptom-monitoring app actually exacerbated symptoms for a small number of patients with psychotic disorders, says John Ainsworth at the University of Manchester, who helped to develop the app. “We need to very carefully manage the initial phases of somebody using this kind of technology and make sure they’re well monitored,” he says.

In a pilot trial published earlier this year, ten US veterans with PTSD were randomly assigned to use PTSD Coach on their own for eight weeks, while another ten used the app with the support and guidance of primary-care providers. At the end of the trial, seven of the ten patients using the app with support showed a reduction in PTSD symptoms, compared with just three of the patients who used the app on their own.

But if apps require medical supervision, that undermines the idea that they will serve as an easy and low-cost way to provide care to the masses. “People think there’s an app for everything,” says Helen Christensen, the director of the Black Dog Institute at the University of New South Wales in Sydney, Australia, who has developed and studied mental-health apps. “It’s actually about how we build systems around apps, so that people have health care.”

Distributing mental-health apps in the developing world presents further challenges. Although mobile technology is spreading rapidly, there are many people who do not have — or cannot afford — smartphones or mobile Internet access. And the content of apps needs to be delivered in local languages and reflect local cultures. “The notion that you can take an intervention and just plop it down in a region where people might not even use the same terms for mental health as you’re using is a little unrealistic,” says Ben-Zeev. “What we might call ‘hearing voices’ in the United States might be something like ‘communicating with your elders’ in a different region, depending on what label people attach to that experience.”

At this point, the notion that apps can deliver quality health care in low-income regions remains largely theoretical. “This is generally where the mHealth field is,” says Natalie Leon, a scientist at the South African Medical Research Council in Cape Town. “It’s a promise of potential effectiveness.”

GOOD PRACTICE

To make good on that promise, apps will have to be tested. Between 2013 and 2015, the number of mobile-health trials registered on ClinicalTrials.gov more than doubled, from 135 to 300. And the number of trials specifically focused on mental and behavioural health increased by 32%, according to a report by the IMS Institute for Health Informatics in Parsippany, New Jersey.

One digital health company that has earned praise from experts is Big Health, co-founded by Colin Espie, a sleep scientist at the University of Oxford, UK, and entrepreneur Peter Hames. The London-based company’s first product is Sleepio, a digital treatment for insomnia that can be accessed online or as a smartphone app. The app teaches users a variety of evidence-based strategies for tackling insomnia, including techniques for managing anxious and intrusive thoughts, boosting relaxation, and establishing a sleep-friendly environment and routine.

Before putting Sleepio to the test, Espie insisted on creating a placebo version of the app, which had the same look and feel as the real app, but led users through a set of sham visualization exercises with no known clinical benefits. In a randomized trial, published in 2012, Espie and his colleagues found that insomniacs using Sleepio reported greater gains in sleep efficiency — the percentage of time someone is asleep, out of the total time he or she spends in bed — and slightly larger improvements in daytime functioning than those using the placebo app. In a follow-up 2014 paper, they reported that Sleepio also reduced the racing, intrusive thoughts that can often interfere with sleep.

The Sleepio team is currently recruiting participants for a large, international trial and has provided vouchers for the app to several groups of independent researchers so that patients who enrol in their studies can access Sleepio for free.

“We think this is the way forward for digital health,” says Espie. Mobile-phone-based treatments, he says, “should be tested and judged like any other intervention. We shouldn’t treat people’s health with any less respect because the treatment is coming through an app.”

This article is reproduced with permission and was first published on April 6, 2016.

Posted in News & updates | Leave a comment

Mental Illness: How to Spot Fact from Fiction

Sensationalist coverage and our brains contribute to misunderstandings about mental health

As the saying goes, all good things must come to an end. For more than eight years, we have authored this column on facts and fictions in mental health, an opportunity for which we are profoundly grateful. Nevertheless, because of growing commitments and other pursuits, we have decided that this will be our last column.

We have written these articles for a simple reason: we live in a world in which mental health literacy is more important than ever. According to survey data published in 2010 by psychiatrist Mark Olfson of Columbia University and psychologist Steven Marcus of the University of Pennsylvania, about 3 percent of Americans are in psychotherapy, with most of them also receiving medication. Moreover, as psychiatrist Thomas Insel, director of the National Institute of Mental Health, observed in a 2014 strategic plan, the incidence of a number of mental health conditions, including autism spectrum disorder and major depression, has soared in recent years, although the significance of these rising rates remains a matter of controversy.

Despite its pervasiveness, many people are woefully misinformed about mental illness. This fact is worrisome because inaccurate notions about mental illness can be harmful. For example, the erroneous belief that people with schizophrenia are prone to violence can lead to unjustified stigma [see “Deranged and Dangerous?”; July/August 2011]. And the unsupported assumption that antidepressants are more effective than cognitive-behavior therapy for the long-term treatment of depression can dissuade individuals from seeking the most beneficial interventions for their illness [see “The Best Medicine?”; October/November 2007].

In this concluding column, we look back at our past contributions and extract some of their most important lessons. We hope to leave readers with a user-friendly kit for sorting fact from fiction about mental health and illness.

A MISUNDERSTANDING MIND

Several common errors of reasoning make all of us susceptible to certain misconceptions about psychological health. For instance, the availability heuristic is a mental shortcut by which we gauge the frequency of an event by the extent to which it is fresh in our mind. For example, the mistaken belief that most children of divorced parents display poor psychological adjustment probably stems from the fact that when a child experiences serious problems after a divorce, we often hear about it. Conversely, when a child adapts well to a divorce—as most do—his or her resilience is almost never discussed. As a result, we may think of divorce as more closely tied to psychological problems than it actually is [see “Is Divorce Bad for Children?”; March/April 2013].

Another common logical error is post hoc, ergo propter hoc, meaning “after this, therefore because of this.” Our minds are continually on the lookout for connections between incidents, which may lead us to conclude that an event preceding the emergence of a psychological condition caused the condition. For instance, many people continue to believe that childhood vaccines (especially those containing the preservative thimerosal) cause autism because the usual time for vaccinating children—soon after they turn one—comes just before the first signs of autism typically become evident. This connection in time is apparently more persuasive to many than the multiple, large epidemiological studies that have debunked the link [see “Autism: An Epidemic?”; April/May 2007].

In addition, many misconceptions about mental illness contain a kernel of truth that can lead us to false conclusions. For example, just because dogs, horses and some other domesticated animals provide emotional warmth that can temporarily relieve anguish does not mean that animal-assisted therapy alleviates the main symptoms of major mental disorders such as autism, schizophrenia and anorexia nervosa [see “Can Animals Aid Therapy?”; June/July 2008].

MISLED BY THE MESSENGER

As information becomes increasingly abundant and accessible, the ability to evaluate articles, books and Web sites grows more crucial. About 3,500 self-help books appear every year, but few are based on research or are subjected to scientific scrutiny [see “Do Self-Help Books Help?”; October/November 2006]. Likewise, many psychology Web sites are replete with misinformation. In a 2012 survey of the sites of eight national autism associations, special education professor Jennifer Stephenson and her co-authors at Macquarie University in Australia found that most of them provided misleading information about the effectiveness of interventions. For example, of 33 autism treatments suggested on these sites, solid empirical support exists for only three. (Those three are grounded in the principles of behavior modification, a technique that reinforces adaptive activities.)

The mainstream media can also spread distortions, whether because of mistakes rising from deadline pressure, misunderstanding of source material or an overzealous desire to appeal to the public. As psychologist Thomas Gilovich of Cornell University observed in his 1991 book, How We Know What Isn’t So, reporters almost always sharpen the central point of an article and leave out peripheral details. They also routinely exaggerate claims in the service of a good story. On October 7, 2013, the front page of The Sun, a popular British tabloid, trumpeted: “1,200 killed by mental patients.” The headline implied that psychiatric patients had murdered 1,200 people in the U.K. Yet that figure included not only patients in the mental health system but also individuals who were judged retrospectively by researchers to be experiencing symptoms of mental illness, a judgment that is highly subjective.

Even when a story is more nuanced, the headline may still hold sway in people’s minds. Psychologist Ullrich Ecker of the University of Western Australia and his colleagues collected data last year showing that deceptive headlines, such as “Fears of Fluoride in Drinking Water” (which topped an article emphasizing the safety of fluoride in water), can provoke biased inferences about the story, leading to misconceptions. Thus, readers must not only continue past the headline but must also carefully encode any details in a story that contradict or add nuance to its title. We should beware, too, of misguided attempts to create balance in stories. Journalists sometimes feel obligated to present both sides of an issue even when the scientific consensus is clearly on one side.

We hope that this column and the more than 50 that came before it have helped educate readers about psychological health in ways that matter for both individuals and society. The tips and analyses we have offered over the years are hardly panaceas, but they can serve as a guide through the increasingly complicated maze of claims about mental health.

Posted in News & updates | Leave a comment