The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy

MILITARY MEDICINE, 181, 9:961, 2016

The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 1: Clinical Implications for Depression, Post-Traumatic Stress Disorder, and Anxiety Marina A. Khusid, MD, ND, MSA; Meena Vythilingam, MD

INTRODUCTION Deployment to a war zone is associated with a significant increase in new-onset post-traumatic stress disorder (PTSD), major depressive disorder (MDD), substance use disorder (SUD), and chronic pain. Several reports estimate that 20 to 30% of troops returning from Operation Enduring Freedom and Operation Iraqi Freedom report symptoms of mental health disorders.1,2 The high prevalence of these conditions related to a war-zone deployment among U.S. service members and veterans results in high, long-term personal, health care, and societal costs.3 Their chronic, debilitating nature and frequent co-occurrence increase the risk of polypharmacy and adverse events, and makes the development of safe, efficacious, nonpharmacologic interventions of great public health importance. Self-management characteristic of such novel nonpharmacologic intervention is even more desirable since it is associated with improved health outcomes, patient engagement, and cost-effectiveness.4 This two-part review aims to assess if mindfulness-based interventions (MBIs) could provide effective self-management strategy to facilitate treatment and tertiary prevention of mental health conditions.

Mindfulness meditation is increasingly accepted among veterans,5 is safe, easy to learn, affordable, and is associated with a growing evidence base. A 2014 Agency for Healthcare Research and Quality comparative effectiveness review concluded that mindfulness meditation is beneficial in reducing consequences related to psychological stress, including depression, substance use, sleep disturbances, and pain.6 Two Deployment Health Clinical Center, Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, 1335 East-West Highway, No. 3-219, Silver Spring, MD 20910. doi: 10.7205/MILMED-D-14-00677

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other systematic reviews that specifically assessed self-care interventions suggest that meditation improves stress-related mental health consequences.7,8 Neuroscientists define meditation as a combination of emotional and attentional training regimes developed to cultivate well-being and improve emotional regulation.9 Traditional cultures view meditation as a practice to train the mind to achieve spiritual and health benefits. Although there are many types of meditation, mindfulness meditation shows the most evidence for mental health, and is the focus of this review.

Jon Kabat-Zinn describes mindfulness as the ability to maintain open, accepting, nonjudgmental awareness in each moment.10 Mindfulness meditation comes from Buddhism and takes many forms in different monastic traditions, such as Zen, Shambhala, and Vipassana. Although these various schools of mindfulness meditation differ slightly with respect to the physical posture assumed, they generally involve sitting still and observing one’s own breath. The process of constantly returning one’s attention to breathing helps train the mind to stay present and control otherwise automatic cognitive responses to stress, intrusive thoughts, and negative emotions.

Traditional mindfulness meditation techniques were first adapted for chronic pain in 1982 by Kabat-Zinn. Several group-based protocols were then developed in an attempt to standardize the delivery of mindfulness meditation for specific clinical conditions. For example, mindfulness-based relapse prevention (MBRP) was developed for individuals with SUDs, and mindfulness-based cognitive therapy (MBCT) was developed to manage depression. Such group-based protocols use a certified instructor to lead 6 to 8 weekly training sessions, while participants practice mindfulness meditation as daily homework. After completion of an 8-week course, participants are encouraged to adopt meditation, practice long-term as a 961

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ABSTRACT Mindfulness-based interventions (MBIs) have been increasingly utilized in the management of mental health conditions. This first review of a two-part series evaluates the efficacy, mechanism, and safety of mindfulness meditation for mental health conditions frequently seen after return from deployment. Standard databases were searched until August 4, 2015. 52 systematic reviews and randomized clinical trials were included. The Strength of Recommendation (SOR) Taxonomy was used to assess the quality of individual studies and to rate the strength of evidence for each clinical condition. Adjunctive mindfulness-based cognitive therapy is effective for decreasing symptom severity during current depressive episode, and for reducing relapse rate in recovered patients during maintenance phase of depression management (SOR moderate [SOR B]). Adjunctive mindfulness-based stress reduction is effective for improving symptoms, mental health-related quality of life, and mindfulness in veterans with combat post-traumatic stress disorder (PTSD) (SOR B). Currently, there is no sufficient data to recommend MBIs for generalized anxiety disorder (SOR B). MBIs are safe, portable, cost-effective, and can be recommended as an adjunct to standard care or self-management strategy for major depressive disorder and PTSD. Future large, well-designed randomized clinical trials in service members and veterans can help plan for the anticipated increase in demand for behavioral health services.

Mindfulness Meditation as Self-Management for Mental Health and Pain, Part 1 TABLE I. Name

Common Mindfulness-Based Group Interventions

Common Indication Chronic Pain, PTSD

Mindfulness-Based Cognitive Therapy (MBCT)

Major DepressiveDisorder

Mindfulness-Based Relapse Prevention (MBRP)

Substance UseDisorders

Mindfulness Training for Smokers (MTS)

Smoking Cessation

Mind-Body Bridging (MBB) and Mindfulness-Based Therapy for Insomnia (MBTI) Mindfulness-Oriented Recovery Enhancement (MORE)

Insomnia

Chronic Pain, and Prescribed Opioid Misuse

lifestyle change, or in health care terms, a self-care strategy. In addition to a similar overall structure of the program, and a common denominator of daily mindfulness meditation practice, each mindfulness-based group intervention has a distinctive component that targets a particular clinical condition it was developed for (Table I).

This is Part 1 of the two-part article. It evaluates the safety and efficacy of mindfulness meditation in the management of depression, PTSD, and anxiety. Part 2 addresses substance and tobacco use disorders, insomnia, and chronic pain. These seven clinical conditions were chosen because of their chronicity, high prevalence in service members and veterans, and frequent co-occurrence. Systematic reviews, clinical trials, and mechanistic studies are assessed to determine whether mindfulness meditation corrects the underlying pathophysiology in addition to improving symptoms, as recommended by the National Institute of Mental Health.11 This two-part review aims to educate clinicians, and policy makers regarding mindfulness meditation mechanisms, safety, and specific clinical indications and contraindications when used as monotherapy, adjunctive to standard care, or as self-care. In addition, we will discuss research limitations and future directions in Part 1, and clinical and implementation considerations in Part 2.

METHODS Comprehensive searches of PubMed and Cochrane databases were performed to identify articles published in English up until August 4, 2015. Each database was searched using the keywords “meditation,” “mental training,” and “mindfulness,” 962

Description In addition to mindfulness meditation, MBSR involves teaching of body scan or yoga to encourage open nonjudgmental observation and acceptance of painful or unpleasant sensation, negative thoughts, or emotions instead of cognitively appraising them, and increasing anticipatory anxiety, avoidance, or other maladaptive patterns.

In addition to mindfulness meditation, MBCT encourages acceptant nonjudgmental observation of negative thoughts and emotions instead of their cognitive appraisal triggering ruminative negative thoughts and habitual emotional reactivity.

In addition to mindfulness meditation, MBRP teaches relapse prevention skills and nonjudgmental, open, and acceptant observation of cravings.

It aims to decouple the negative thoughts and emotions that are associated with cravings and relapse.

In addition to mindfulness meditation, MTS provides targeted training in how to apply mindfulness to smoking relapse determinants such as smoking triggers, strong emotions, addictive thoughts, urges, and withdrawal symptoms.

In addition to mindfulness meditation, MBB and MBTI use behavioral strategies to reduce night wakefulness.

In addition to mindfulness meditation, MORE teaches neutral, open, and acceptant observation of painful sensations. It also incorporates positive psychology, and behavioral techniques directed toward neuroscientific underpinnings of addiction.

with search criteria restricted to selectively identify randomized clinical trials (RCTs), and systematic reviews. After eliminating redundant references, this search yielded 1,523 citations, and their abstracts were reviewed. Articles were excluded if studies were conducted in children or adolescents, did not use mindfulness meditation, or did not specifically address symptoms of depression, PTSD, and anxiety, either as primary or secondary outcome measures. Studies in the civilian population were included because of the paucity of clinical research in service members and veterans. Articles were included according to the following criteria: (1) Participants: civilian, active duty, and veteran adults with documented or reported diagnosis of conditions of interest (i.e., PTSD, MDD, anxiety disorders, pain, SUD, tobacco use, insomnia). Military and veteran samples were favored in evaluation of combat-PTSD trials.

(2) Intervention: mindfulness meditation or group MBI (mindfulness-based stress reduction [MBSR], MBCT, MBRP, mind-body bridging [MBB], mindfulnessoriented recovery enhancement [MORE], etc.).

(3) Comparator: active comparator (e.g., antidepressants, psychotherapy, treatment as usual [TAU]) or wait list control. Studies that use active comparator consistent with current standard of care were prioritized, but in their absence, studies with a wait list control were also included.

(4) Outcomes: change in symptom severity, relapse rate, utilization of standard pharmacotherapy, quality of life, functional status, and mindfulness.

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Mindfulness-Based Stress Reduction (MBSR)

Mindfulness Meditation as Self-Management for Mental Health and Pain, Part 1

(5) Timing and setting: inclusion criteria were not limited by timing and setting.

(6) Study design: systematic reviews, meta-analyses, and RCTs with sample size greater than 10 subjects in the intervention group.

TABLE II.

Mindfulness Meditation for Depression Mechanism of Action

Mindfulness meditation activates left prefrontal cortex (PFC), and is associated with reduced vulnerability to depression.13,14 It also results in a significant reduction in rumination and emotional reactivity,15 two maladaptive patterns of responding associated with increased depression risk.16 Meditation changes the relationship to negative thoughts by making one more aware, yet more open and accepting of negative experiences,17 thereby decreasing their intensity. Finally, mindfulness meditation cultivates self-compassion,16 which in turn fosters a positive effect and decouples the relationship between reactivity to stress and the likelihood of depression relapse.18 Clinical Research

The most commonly studied form of meditation in the treatment of depression is MBCT. It was initially studied in recovered patients who had a history of at least three major depressive episodes with an aim to decrease their risk of relapse. The systematic review and meta-analysis by Clarke et al (n = 29 RCTs, LOE-2) demonstrated that the MBCT group had 21% reduction in the average risk of developing a new episode of MDD by 12 months. Teasdale et al19 (n = 145, LOE-2) were the first to show that MBCT plus TAU significantly reduced the relapse rate compared to TAU alone (36% vs. 66%, respectively) during a 12-month follow-up. A similar reduction in the relapse rate was observed in a replication study (n = 75, LOE-2) comparing MBCT plus TAU to TAU only (36% vs. 78%, respectively).20 In another RCT (n = 123, LOE-2) with a 15-month follow-up, MBCT plus maintenance antidepressants were more effective at reducing the

Level of evidence (LOE) Adopted From Ebell et al, 2004

Study Quality

Description for Treatment and Prevention Studies

LOE-1: Good-Quality Patient-Oriented Evidence

Systematic reviews, meta-analyses, or RCTs with consistently replicated findings High-quality individual RCTs: allocation concealed, blinding if possible, intention-to-treat analysis, adequate statistical power, adequate follow-up (greater than 80%), use of a specific active control Systematic reviews or meta-analyses of lower-quality studies with inconsistent results Lower-quality clinical trials: small, nonrandomized, unconcealed allocation; not blinded; no intention-to-treat analysis; inadequate follow-up; use of nonspecific or inactive control Consensus guidelines, extrapolations from bench research, usual practice, opinion, disease-oriented evidence

LOE-2: Limited-Quality Patient-Oriented Evidence LOE-3: Other Evidence

TABLE III.

Strength of Recommendation Taxonomy Adopted From Ebell et al, 2004

Strength of Recommendation (SOR) SOR A (Strong) SOR B (Moderate) SOR C (Weak)

Description Recommendation on the basis of consistent and good-quality patient-oriented evidence Recommendation on the basis of inconsistent or limited-quality patient-oriented evidence Recommendation on the basis of consensus, usual practice, opinion, disease-oriented evidence, or case series for studies of treatment or prevention

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Using the criteria defined here, 52 peer-reviewed journal articles of the 1,523 citations were found to be relevant and examined for this review. Each key study was evaluated for scientific rigor and a level of evidence (LOE-1 to LOE-3, Table II) was assigned using the Strength of Recommendation Taxonomy (SORT).12 The findings are organized by presenting the trials investigating mindfulness meditation as monotherapy separately from those studying its adjunctive applications. Finally, the quality, quantity, and consistency of the body of evidence for each clinical outcome of interest, and the strength of recommendation (SOR) (SOR A-strong, SOR B-moderate, or SOR C-weak, Table III) were determined using SORT criteria.12 The SOR was considered to be strong (SOR A), consistent, and good quality if it was based on (1) Cochrane reviews with a clear recommendation, (2) a U.S. Preventive Services Task Force Grade A recommendation, (3) systematic reviews or meta-analyses of good-quality RCTs, or (4) consistent findings from at least two good-quality RCTs. If the body of evidence did not meet one of these four parameters, its strength of evidence was considered moderate (SOR B), and it represents either (1) consistent results of lower quality clinical trials, (2) inconsistent results of good-quality trials, or (3) consistent results of limited-quality trials. Finally, SOR C represents weak SOR, and is decided on the basis of consensus, usual practice, opinion, disease-oriented evidence, or case series. Mechanistic research was presented to provide clinical context, but was not considered in the SOR rating process.

RESULTS

Mindfulness Meditation as Self-Management for Mental Health and Pain, Part 1

Strength of Recommendation

Adjunctive MBCT is more effective than TAU alone in reliably reducing depression relapse rates, and time to new relapse or recurrence in recovered patients with a prior history of three or more episodes of recurrent depression (SOR B).

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It effectively reduces the severity of depressive symptoms in remitted patients and those with active episodes, irrespective of the number of prior episodes of major depression (SOR B).

Adjunctive MBCT is cost-effective and significantly decreases psychiatric comorbidity, and antidepressant use (SOR B). We recommend offering adjunctive MBCT followed by daily mindfulness meditation practice as a self-management strategy to patients with MDD during continuation and maintenance phases of treatment.

Although the efficacy of MBCT monotherapy for depressive relapse prevention was comparable to maintenance antidepressants in one large trial with 24-month follow-up,23 we recommend exercising caution, and waiting for this finding to be replicated before implementing in clinical practice. Most clinical environments will not be able to provide the rigorous follow-up during antidepressant taper and thereafter, as Kuyken et al did. Other clinical factors need to be considered, such as the patient’s preference and commitment to adhere to a regular meditation practice, the severity and number of prior episodes, a history of hospitalizations, co-occurring conditions, absolute or relative contraindications to antidepressants (e.g., pregnancy), and family and social support. If mindfulness meditation is chosen as a treatment option, regular and frequent follow-up visits are recommended during the first 6 months.

Mindfulness Meditation for PTSD Mechanism of Action

Mechanistic research of mindfulness meditation illustrates how this intervention can be beneficial in addressing PTSD neural pathology. Many PTSD symptoms result from decreased PFC activation and insufficient inhibition of the amygdala.

This leads to overactivity of the amygdala, symptomatically manifesting as fear, phobic avoidance, hyperarousal, poor impulse control, and re-experience of intrusive negative thoughts and emotions and painful memories. Creswell’s et al34 neuroimaging findings demonstrate that mindfulness meditation has the opposite effect on the PFC-amygdala neurocircuit by activating the PFC and reducing bilateral amygdala activity. This neural mechanism results in improved emotional regulation and impulse control through PFC inhibition of negative emotions generated by the amygdala.

Clinical Research

Clinical research on mindfulness meditation for PTSD in service members and veterans is limited in number and quality of RCTs. Most studies have methodological challenges, including small sample size,35,36 lack of blinding of outcome assessors,35,36 evaluation of treatment fidelity,35,36 and short follow-up.35–37 Such methodological shortcomings make clear conclusions about efficacy of MBIs for PTSD challenging and require careful interpretation.

The largest and most rigorous RCT was completed by Polusny et al37 It compared adjunctive MBSR and presentcentered group psychotherapy in veterans with PTSD diagnosis MILITARY MEDICINE, Vol. 181, September 2016

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recurrence/relapse rate than antidepressants alone (47% vs.

60%, respectively).21 MBCT used adjunctively with antidepressants was also more effective in reducing depressive symptoms, psychiatric comorbidity, and rates of antidepressant use, while keeping costs the same. Godfrin et al (n = 102, LOE-2)22 showed that adjunctive MBCT significantly lowered the recurrence rate and increased the time to the first relapse when compared to TAU alone in individuals with a history of three or more depressive episodes and followed for 12 months after intervention. Kuyken et al23 (n = 424, LOE-1) found that effectiveness of MBCT with support to taper or discontinue antidepressants was not different than that of maintenance antidepressants in extending the time to new relapse or recurrence of depression over a follow-up of 24 months.

Improved quality of life and reduced depressive symptoms were also reported.23,24 Forkman et al25 (n = 130, LOE-2) suggest that adjunctive MBCT more effectively decreases suicidal ideations in depressed patients than TAU alone.

Two studies by Van Aalderen et al26,27 (n = 103, LOE-2; n = 124, LOE-2) were the first to show that adjunctive MBCT is as effective for patients who currently experience major depressive episode as for those who are in remission, and that it is more effective than TAU alone in decreasing the severity of current depressive symptoms. A recent systematic review and meta-analysis by Strauss et al28 focused on trials of patients with current depressive episode, and reported significant postintervention improvement in depressive symptom severity with a large effect size in favor of MBIs. MBCT was also studied as a primary treatment. Two RCTs by Segal et al (n = 160, LOE-2)29 and by Kuyken et al (n = 424, LOE-1)23 show that MBCT monotherapy was as effective as maintenance antidepressants for preventing depressive relapses, decreasing residual depressive symptoms, and improving quality of life.23,29 This therapeutic gain was maintained for up to 2 years with ongoing mindfulness practice without serious adverse events, and at similar costs.23 Another RCT (n = 45, LOE-2) suggests that MBCT monotherapy was equally as effective as cognitive behavioral therapy (CBT) in decreasing symptoms of nonmelancholic depression, maintained at 6- and 12-month follow-ups.30 Geschwind et al (n = 130, LOE-2) and Pots et al (n = 76, LOE-2) compared MBCT monotherapy to a wait list control in individuals with mild and moderate depression. They showed that MBCT reduces residual depressive symptoms irrespective of the number of previous episodes of major depression.31 Home mindfulness meditation practice8 and MBCT learned via the Internet or telephone32,33 also showed benefit in reducing depressive symptoms but need to be investigated further.

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Strength of Recommendation

We suggest that adjunctive MBSR is offered to individuals with combat PTSD interested in self-management to decrease PTSD symptoms and improve mental health–related quality of life, and mindfulness skills (SOR B).

Mindfulness Meditation for Anxiety Disorders Mechanism of Action

Functional magnetic resonance imaging studies by Goldin et al show that MBSR employs both emotion and attention regulation to control social anxiety disorder (SAD) symptoms.

It reduces negative emotions, avoidance, and reactivity, and enhances emotional regulation through amygdala inhibition.46,47 Negative self-beliefs were also attenuated through MILITARY MEDICINE, Vol. 181, September 2016

meditation-induced attention regulation in the parietal cortex neural networks.46 Clinical Research

A 2006 Cochrane systematic review by Krisanaprakornkit et al (LOE-3) included two RCTs in patients with a diagnosis of anxiety disorder. Reduction in anxiety symptoms with mindfulness meditation plus TAU was similar to TAU plus another mind-body relaxation technique.48 The 2014 systematic review by Bolognesi et al49 (LOE-3) included 9 trials utilizing either MBSR, MBCT, or acceptance-based behavioral therapy, and reported that MBIs were beneficial in reducing symptoms of anxiety, tension, worrying, and depression in generalized anxiety disorder (GAD) patients.

Since most studies included in both these reviews did not use a standard of care as control condition, but were either uncontrolled or used education program or wait list controls, their findings have limited application in clinical practice.

Strauss et al28 (LOE-2) conducted a meta-analysis of RCTs where all studies included only participants who were diagnosed with current episode of anxiety disorder, but did not show MBI effectiveness.

Several subsequent RCTs were published since. Arch et al50 conducted an RCT in patients with heterogeneous anxiety diagnoses (n = 71, LOE-2) compared MBSR to CBT and included a three-month follow-up. MBSR was significantly better than CBT in patients who were moderately anxious and had concurrent moderate-to-severe depressive symptoms.

However, CBT was significantly better than MBSR in highly anxious patients with mild or no symptoms of depression.

Hoge et al51 (n = 93, LOE-2) reported that compared to stress management education groups MBSR was more effective at lowering scores on some anxiety scales in patients with GAD. Another RCT (n = 91, LOE-2) compared Internetbased mindfulness intervention to an online discussion forum control in patients with various anxiety diagnoses.52 Participants in the Internet-based mindfulness intervention who practiced mindfulness exercises by listening to audio files had a significant reduction in symptoms of anxiety, depression, and insomnia, and achieved improved quality of life compared to the control group.

Goldin et al53 conducted an RCT in individuals with SAD (n = 56, LOE-2). MBSR monotherapy was compared to aerobic exercise and no treatment group. MBSR led to a significantly greater decrease in negative self-views, an increase in positive self-views, decreased SAD-related disability, and increased mindfulness after 8 weeks. At the 3-month follow-up, both MBSR and aerobic exercise were associated with reduced SAD severity and increased well-being and selfesteem when compared with the untreated SAD group.54 Strength of Recommendation

The current evidence shows inconsistent direction of effect on anxiety symptoms, and at this time does not show that adjunctive mindfulness meditation provides added benefit compared 965

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or subthreshold PTSD (n = 116, LOE-1). Study participants did not use any other psychotherapeutic treatment during the study, but some were on psychoactive medications used at stable doses for at least 2 months before entering the study.

MBSR resulted in a greater decrease of PTSD symptoms on both the PTSD Checklist and the Clinician-Administered PTSD Scale. MBSR group also showed improvement of depressive symptoms, mindfulness, and quality of life. This therapeutic improvement was sustained during the 9-week intervention administration, and at 2-months follow-up. This RCT was well designed with allocation concealment, blinding of outcome assessors, use of credible active control, and intention-to-treat analysis. Although treatment drop out was higher in MBSR group (22% vs. 7%), dropout rates were lower than those reported for the first-line therapies such as prolonged exposure (28–44%),38–41 and cognitive processing therapy (27–35%).42,43 MBSR was well tolerated by veterans with combat PTSD, which is consistent with prior studies.35,36 Findings from earlier pilots of smaller size, and lower methodological quality are not as clear cut. In Kearney’s randomized controlled pilot (n = 47, LOE-2) veterans with PTSD received TAU alone or MBSR plus TAU and were followed for 4 months.35 Although no difference was noted immediately after intervention, veterans in the adjunctive MBSR group showed a clinically significant change in PTSD symptoms, mental health-related quality of life, and mindfulness skills. Another randomized controlled pilot36 (n = 33, LOE-2) in veterans with PTSD compared 8-week mindfulness and psychoeducation interventions, partially administered via telephone. Although the study showed veterans’ satisfaction with telehealth mindfulness intervention, the decrease in PTSD symptoms was only temporary. A small size of the study and a brief administration via telephone instead of traditional group MBSR course administered in person precludes us from drawing reliable conclusions. Two RCTs in Iranian combat veterans with PTSD (n = 62, n = 28 LOE-2) showed that adjunctive MBSR was more effective than TAU in regulating depressive and anxious moods, and improving healthrelated quality of life.44,45

Mindfulness Meditation as Self-Management for Mental Health and Pain, Part 1

to standard treatment alone in patients with GAD, and other anxiety diagnoses (SOR B). However, when depressive symptoms are concurrent with low-to-moderate anxiety, mindfulness meditation may offer additional benefit in reducing depressive symptoms, when used adjunctively with standard care.

DISCUSSION

TABLE IV.

Future Research Directions To enhance the speed of research translation into effective care for deployment-related mental health conditions, future research directions should focus on replication of highquality RCTs in service members and veterans. These RCTs should be adequately powered, use specific active controls, concealed randomization, and include an intention-to-treat analysis with sufficient follow-up. The amount of instruction and amount of home practice needs to be accurately reported to define the effective mindfulness meditation dose. Then, adequate follow-up rates and duration will help fully examine the effects of meditation dose on objective health indices, such as recurrences, hospitalizations, and mortality.

Comparative effectiveness studies between standard care alone versus standard care plus meditation versus meditation alone will help to distinguish between meditation effectiveness as monotherapy or adjunctive therapy. When there is no difference between the intervention and specific active control, it may be unclear if the interventions are equal in efficacy or if the study was too underpowered to detect any difference. Therefore, future comparative effectiveness trials should clearly specify if they are investigating equivalence, superiority, or inferiority; define the margins of clinical significance; and ensure adequate sample sizes.

In congruence with the National Institute of Mental Health research domain criteria, research questions should consider neurobiological mechanisms in addition to highquality RCT design. This strategy will help determine if mindfulness meditation has a long-term therapeutic potential through its ability to correct underlying neural pathology in addition to symptomatic efficacy. Finally, future comparison of group, home practice, or telehealth approaches in helping individuals to learn mindfulness meditation skills and maintain consistent practice will help in the selection of the most cost-effective intervention.

Clinical Recommendations

Table IV summarizes clinical indications and SOR for MBI use in management of depression, PTSD, and anxiety. A

Indications and Strength of Recommendation

Condition

Recommendation

Major Depressive Disorder

1. We suggest offering adjunctive MBCT followed by daily mindfulness meditation practice as a self-management strategy to patients with current symptoms of major depressive disorder to decrease symptom severity and improve quality of life (SOR B).

2. We suggest offering adjunctive MBCT followed by daily mindfulness meditation practice as self-management strategy to recovered patients during the continuation or maintenance phase of treatment to lower their chance of MDD relapse (SOR B).

We suggest adjunctive MBSR is offered to individuals with combat PTSD interested in self-management to decrease PTSD symptoms and improve mental health–related quality of life, and mindfulness skills (SOR B).

There is no sufficient evidence for or against using mindfulness-based interventions for anxiety disorders at this time (SOR B).

PTSD Anxiety

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Methodological Limitations This review was written with the purpose of providing guidance to clinicians and policy makers. Therefore, we chose to include clinical trials, systematic reviews, and meta-analyses only, as these designs are superior in determining efficacy, and comparative effectiveness. The majority of mindfulness meditation trials were limited by methodological challenges.

Many were not conducted in service members or combat veterans, had a small sample size, did not report if allocation was concealed, or did not use blinded outcome assessors.

Therefore, most research reported in this review was of limited quality and received only an LOE-2 rating.

Since not all RCTs used specific active controls, the accuracy of isolating specific MBI effects is also limited. A “specific active control” compares the effectiveness of the intervention to another known therapy, such as antidepressants or CBT. When specific active controls were used, they often varied from one study to another contributing to the challenge of evaluating the consistency of findings.

Many studies used one selected outcome measure validated for monitoring improvement or progression of a particular clinical condition. Although adequate for clinical use, these outcome measures may differ in their sensitivity in detecting mindfulness meditation effects. In addition, the variations in measure sensitivities as well as the small number of trials within each outcome domain may have contributed to inconsistent results.

Some studies did not incorporate an intent-to-treat analysis, a strategy that includes all initially randomized patients, regardless of their completion of the trial. This allows for a more accurate assessment of the effectiveness of an intervention, similar to a real-world scenario where patient adherence to treatment varies. Similarly, many trials did not consistently report the frequency and duration of meditation practiced by participants during the intervention period and during the follow-up period. Therefore, it is hard to make conclusions about

the effective dose of mindfulness meditation, or whether consistent practice is required to maintain therapeutic gain.

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detailed discussion regarding clinical and implementation considerations is included in Part 2 of this review.

ACKNOWLEDGMENT

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We thank Richard Isaac for his help in editing the manuscript.

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CONCLUSION The findings of this review support the use of MBIs as an adjunct to standard treatment of MDD, and PTSD. Limitedquality patient-oriented evidence demonstrates that adjunctive MBCT is beneficial in patients with current depressive episode, and as a continuation or maintenance therapy in recovered patients with MDD. Current evidence also supports adjunctive MBSR use in management of PTSD. Since the evidence for monotherapy is not as strong at this time, we advise against the use of mindfulness meditation alone to avoid delays in offering first-line treatments for psychiatric conditions. Present evidence does not support using MBIs for GAD. When patients are open to learning mindfulness meditation and committed to adopting it as a health behavior change, it can become a powerful self-care tool that encourages individuals to actively engage in their enhancing mental health.

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