A new frontier in treatment for mental illnesses and other chronic conditions may not come from pharmaceutical companies, but from within, as mindfulness practices gain traction.

Mindfulness practices as we know them today are rooted in 2500-year-old Buddhist meditation practices and are often described as “…paying attention to the present moment experiences with openness, curiosity, and a willingness to be with what is” (http://marc.ucla.edu/). Herbert Benson, MD, founder of the Benson-Henry Institute for Mind Body Medicine at Massachusetts General Hospital, is often credited with bringing mindfulness into the realm of Western medicine. His 1975 book The Relaxation Response outlined techniques to combat the harmful effects of stress with relaxation methods similar to meditation.

These practices didn’t stay lodged in the 1970s like a macramé plant holder, however. Several structured mindfulness programs have since been developed and are being implemented in clinical practice. One of these is mindfulness-based stress reduction (MBSR), pioneered by Jon Kabat-Zinn, PhD, MPH, founding executive director of the Center for Mindfulness in Medicine, Health Care, and Society at the University of Massachusetts Medical School (http://1.usa.gov/1KZm8DF).

Another is mindfulness-based cognitive therapy (MBCT), a blend of MBSR and cognitive-behavioral therapy established by Zindel Segal, PhD, a cognitive psychologist at the University of Toronto, along with colleagues Mark Williams, PhD, and John Teasdale, PhD (http://1.usa.gov/1e0vpOo).

According to Gregory Lewis Fricchione, MD, director of the Benson-Henry Institute, “…mindfulness and other meditative techniques can provide adjunctive benefits for health and that includes mental health.”

But Fricchione does acknowledge pockets of resistance. “Many physicians who consider themselves grounded in Western science will see mindfulness-based programs for mental health disorders as being somewhat faddish and relatively impotent in treating mental disorders, especially severe ones,” he said.

That attitude may be slowly changing as researchers have begun to systematically investigate the effects of mindfulness interventions for various physical and mental health conditions, including cancer, stroke, multiple sclerosis (MS), pain, anxiety, and depression (http://1.usa.gov/1SJXFBR). The results of these studies may help inform physicians of the effectiveness and possible uses of mindfulness interventions in clinical practice.

According to a recent work, 79% of medical schools offer some element of mindfulness training, noted co-investigator David Black, PhD, MPH, director of the American Mindfulness Research Association and assistant professor of preventive medicine at Keck School of Medicine at the University of Southern California, whose previous research suggests mindfulness may improve sleep quality in older adults (Black DS et al. JAMA Intern Med. 2015;175[4]:494-501).

Research and education centers dedicated to mindfulness have proliferated (http://bit.ly/1MsasH5). Yet findings from the literature have historically been variable, partly because mindfulness is not a singular modality, but rather inclusive of diverse practices like MBSR, MBCT, transcendental meditation, yoga, and tai chi, making it difficult to compare and generalize results across studies.

Helen Lavretsky, MD, MS, a geriatric psychiatrist and associate professor-in-residence at University of California, Los Angeles, acknowledged that in the past, early research on mindfulness practices had not been rigorous enough. She also said that “…drug development has not [had] any significant advances to improve treatment response in older adults,” limiting medications psychiatrists can prescribe for conditions like depression, particularly for patients who don’t respond to existing pharmacotherapies or who experience adverse drug reactions. Therefore, patients have been the ones driving the trend to incorporate mindfulness practices into their care, noted Lavretsky. “The patients ask, ‘What else can I possibly do?’” she said.

Despite shortcomings of past research, recent more rigorous studies suggest mindfulness practices may offer some clinical benefit in treating depression and anxiety.

A recent study found MBCT to be as effective as maintenance antidepressants for preventing depressive relapse. All 424 trial participants had at least 3 prior depressive episodes, were currently in full or partial remission, and were taking maintenance antidepressants. Investigators randomly assigned the participants to an intervention group receiving MBCT (while either tapering or discontinuing antidepressants) or a control group continuing to take maintenance antidepressants and measured relapse rates over 15 months and at 2 years after intervention (Kuyken W et al. Lancet. 2015;386[9988]:63-73).

The MBCT group attended 8 weekly group sessions and performed homework assignments emphasizing mindfulness and cognitive-behavioral skills. Of patients in the MBCT intervention group, 44% relapsed over the course of the study compared with 47% of the patients in the control group.

Among patients who had experienced severe childhood abuse, 47% receiving MBCT relapsed compared with 59% receiving maintenance antidepressants, suggesting that MBCT may protect against relapse more effectively in certain high-risk individuals.

Mindfulness techniques may also modestly improve symptoms for patients who have experienced trauma, according to a study of 116 veterans with posttraumatic stress disorder (PTSD) (Polusny MA et al. JAMA. 2015;314[5]:456-465). The study found that at the 2-month follow-up, patients who completed a modified MBSR program showed 48.9% improvement in self-reported symptom severity, compared with 28.1% improvement in the control group that completed 9 weekly present-centered group therapy (PCGT) sessions in which they discussed life difficulties.

When clinicians assessed the patients’ symptoms instead of relying on self-reporting, patients in the MBSR group showed 66.7% improvement in symptom severity, compared with 54.5% improvement for the PCGT group.

A 2014 meta-analysis of 47 randomized clinical trials (RCTs), comprising 3515 participants collectively, examined the evidence for the efficacy and comparative effectiveness of meditation among patients with mental or physical conditions such as anxiety, lower back pain, or heart disease.

The study reported that meditation programs, with the exception of mantra meditation, can moderately improve negative effects of psychological stress, including anxiety, depression, and pain, when compared with active control groups that accounted for nonspecific effects of time, attention, and patient expectations (Goyal M et al. JAMA Intern Med. 2014;174[3]:357-368). Meditation programs did not, however, prove more effective than specific active programs like exercise or progressive muscle relaxation, and there was insufficient evidence that meditation had any positive effect on mood or on stress-related behaviors linked to health, like eating habits or substance abuse.

A more recent overview of systemic reviews and meta-analyses similarly found that MBSR and MBCT interventions may help treat not just depression, but also anxiety, pain, and other chronic conditions (Gotink RA et al. PloS One. 2015;10[4]:e0124344). Although the effect size of these mindfulness interventions tended to be small to moderate, the findings suggest that mindfulness may have a place in the clinic and pave the way for additional trials investigating efficacy and effectiveness.

Although the exact mechanism whereby mindfulness alleviates symptoms of depression, anxiety, and PTSD remains unknown, evidence suggests that mindfulness meditation may be associated with structural and functional changes in brain areas responsible for attention, emotional regulation, and self-awareness, suggesting directions for future research (Tang YY et al. Nat Rev Neurosci. 2015;16[4]:213-225).

Methodological challenges may partly explain why evidence supporting the clinical efficacy of mindfulness historically has been weak or modest for most health conditions. Previous trials have suffered from low participation rates, short study duration, and patient group variability (Goyal M et al. JAMA Intern Med. 2014;174[3]:357-368).

Randomized clinical trials, considered to be the clinical research gold standard, are often used to test drug efficacy. However, unlike pharmacological interventions, mindfulness protocols can require hours of training and sustained practice. Therefore, some suggest that RCTs may not be the most effective way to study mindfulness interventions because they cannot fully consider the effects of conscious choice and active engagement characteristic of mindfulness interventions (Walach et al. JAMA Intern Med. 2014;174[7]:1193-1194).

Furthermore, unlike blinded drug trials, concealing meditation as treatment is not possible. Therefore, long-term comparative cohort studies have been suggested as more appropriate for evaluating mindfulness interventions (Wallach et al. JAMA Intern Med. 2014;174[7]:1193-1194).

“Expectation and belief are important components in any therapeutic encounter,” said Fricchione. “So the belief that meditation can be helpful and the ensuing desire to learn it will become active ingredients in the healing effects of the meditation.” Fricchione noted that it’s difficult to establish a “sham” mindfulness practice as an active study control.

Sara Lazar, PhD, assistant professor of psychology at Harvard Medical School, whose research has shown MBSR to be associated with structural changes in the brain, believes that the perceived need for a sham intervention may be overblown.

“No one does sham surgeries,” said Lazar, adding that often, research on “meditation is held to a higher standard than [other] medical practices.”

Lazar also pointed out that an active control group can mask an intervention’s therapeutic effects. What’s more, another type of masking effect due to the “frustrebo response,” whereby patients not receiving the intervention become disappointed and pursue independent mindfulness practices, can underestimate an intervention’s effect size (Gotnick RA et al. PLoS One. 2015;0[4]:e0124344).

On the other hand, waitlist and passive-control groups may also yield misleading results, as they don’t account for attentional effects of mindfulness interventions that arise from patient interactions with health care professionals. Lazar believes that ideally, studies need 3 groups: treatment as usual, an active control, and the intervention.

According to some experts, future research should focus on noninferiority trials assessing the efficacy of mindfulness interventions relative to established therapies. Such research should also account for treatment administrator certification as well as the consistency of participants’ practice (Rutledge T et al. JAMA Intern Med. 2014;174[7]:1193).

Steven M. Tovian, PhD, clinical and health psychologist and associate professor of psychiatry and behavioral sciences at Northwestern University’s Feinberg School of Medicine, emphasized the importance of managing patient expectations.

“This is not a cure,” he said. “It’s a control mechanism.” Tovian uses MBSR techniques in conjunction with biofeedback to help neutralize patients’ stress and anxiety, help control pain, and reduce levels of arousal that can exacerbate coexisting medical conditions. For example, he has used mindfulness with biofeedback to help a patient with tinnitus and associated sleep problems to fall asleep faster.

Tovian admits that some patients find mindfulness interventions too plodding. “We live in a world of computers and fast relief,” he said. “We can take a Xanax and get an effect within 20 minutes.”

“People have to like it and make it their lifestyle,” Lavretsky added. “Those who adhere do really well.”

For patients to have access to formalized mindfulness programs, clinicians must have access to training. And that training isn’t cheap. At the University of California, San Diego (UCSD), Center for Mindfulness, the cost of MBCT and MBSR training is $8440 and $9500, respectively, for a program that includes 10 to 12 days of instruction and mentorship sessions (http://mbpti.org/mbct-teacher-qualification-and-certification/). Among other prerequisites, participants must have an advanced degree in a mental health field, previous meditation training, and a committed daily meditation practice (http://bit.ly/1M68nTs).

According to Steven D. Hickman, PsyD, director of the Center for Mindfulness and associate clinical professor in the Department of Psychiatry at UCSD, while MBSR need not be administered by health care professionals, it is often administered by therapists and even by some physicians. Hickman says that MBSR is usually (although not always) an out-of pocket expense for patients because it’s not considered treatment, but a way to help patients hone their coping skills. As a form of psychotherapy, MBCT is usually offered by therapists, social workers, or psychiatrists and can be billed to insurance as group therapy.

These costs related to MBSR and MBCT could translate to a lack of access for patients who might otherwise benefit from such interventions. But resistance at the professional level, at least, may be waning.

Twenty years ago, said Tovian, “I think there was push-back about mind/body duality issues, but not anymore.” Tovian also noted that medical training, particularly as it relates to primary care, is now more accepting of approaches that address psychosocial factors associated with disease.

Whether physicians choose to recommend mindfulness practices to their patients may ultimately depend not just on accessibility, but on their willingness to incorporate mindfulness approaches into their clinical toolbox that are supported by the evidence base.