Gulf War Illness: A Randomized Controlled Trial Combining Mindfulness Meditation and Auricular Acupuncture.

Background: Many Gulf War (GW) Veterans report chronic symptoms including pain, fatigue, and cognitive impairment, commonly defined as Gulf War Illness (GWI). Complementary and integrative health (CIH) therapies may potentially improve multiple symptoms of GWI. Objective: To examine the effectiveness of combining 2 commonly available CIH therapies, mindfulness meditation and auricular acupuncture, in improving health-related functioning and multiple symptom domains of GWI (e.g., pain, fatigue). Methods: This study was a randomized controlled trial in which Veterans with GWI were randomly assigned to either the intervention group (n = 75), wherein they received 2 distinct CIH therapies - mindfulness meditation and auricular acupuncture, or the active control group, wherein they received a GW Health Education (GWHE) program (n = 74), each lasting 8 weeks. Self-report health measures were assessed at baseline, endpoint, and 3 month follow-up. Results: In the intention-to-treat analyses, there were significant between-group differences for mental-health related functioning, fatigue, depression symptoms, and Kansas total severity scores for symptoms in which the CIH group had improved scores for these outcomes at endpoint compared to the GWHE group (all P ≤ .05). The CIH group also had significant reductions in pain interference at endpoint and follow-up compared to baseline (estimated marginal mean difference: -2.52 and -2.22, respectively; all P = .01), whereas no significant changes were observed in the GWHE group. For pain characteristics, the GWHE group had a worsening of pain at endpoint compared to baseline (estimated marginal mean difference: +2.83; P = .01), while no change was observed in the CIH group. Conclusion: Findings suggest a possible beneficial effect of combining 2 CIH therapies, mindfulness meditation and auricular acupuncture, in reducing overall symptom severity and individual symptom domains of fatigue, musculoskeletal, and mood/cognition in Veterans with GWI. Trial Registration: Clinical Trials identifier NCT02180243.

Mindfulness-Based Stress Reduction vs Escitalopram for the Treatment of Adults With Anxiety Disorders: A Randomized Clinical Trial.

Importance: Anxiety disorders are common, highly distressing, and impairing conditions. Effective treatments exist, but many patients do not access or respond to them. Mindfulness-based interventions, such as mindfulness-based stress reduction (MBSR) are popular and can decrease anxiety, but it is unknown how they compare to standard first-line treatments. Objective: To determine whether MBSR is noninferior to escitalopram, a commonly used first-line psychopharmacological treatment for anxiety disorders. Design, Setting, and Participants: This randomized clinical trial (Treatments for Anxiety: Meditation and Escitalopram [TAME]) included a noninferiority design with a prespecified noninferiority margin. Patients were recruited between June 2018 and February 2020. The outcome assessments were performed by blinded clinical interviewer at baseline, week 8 end point, and follow-up visits at 12 and 24 weeks. Of 430 individuals assessed for inclusion, 276 adults with a diagnosed anxiety disorder from 3 urban academic medical centers in the US were recruited for the trial, and 208 completed the trial. Interventions: Participants were 1:1 randomized to 8 weeks of the weekly MBSR course or the antidepressant escitalopram, flexibly dosed from 10 to 20 mg. Main Outcomes and Measures: The primary outcome measure was anxiety levels as assessed with the Clinical Global Impression of Severity scale (CGI-S), with a predetermined noninferiority margin of -0.495 points. Results: The primary noninferiority sample consisted of 208 patients (102 in MBSR and 106 in escitalopram), with a mean (SD) age of 33 (13) years; 156 participants (75%) were female; 32 participants (15%) were African American, 41 (20%) were Asian, 18 (9%) were Hispanic/Latino, 122 (59%) were White, and 13 (6%) were of another race or ethnicity (including Native American or Alaska Native, more than one race, or other, consolidated owing to low numbers). Baseline mean (SD) CGI-S score was 4.44 (0.79) for the MBSR group and 4.51 (0.78) for the escitalopram group in the per-protocol sample and 4.49 (0.77) vs 4.54 (0.83), respectively, in the randomized sample. At end point, the mean (SD) CGI-S score was reduced by 1.35 (1.06) for MBSR and 1.43 (1.17) for escitalopram. The difference between groups was -0.07 (0.16; 95% CI, -0.38 to 0.23; P = .65), where the lower bound of the interval fell within the predefined noninferiority margin of -0.495, indicating noninferiority of MBSR compared with escitalopram. Secondary intent-to-treat analyses using imputed data also showed the noninferiority of MBSR compared with escitalopram based on the improvement in CGI-S score. Of patients who started treatment, 10 (8%) dropped out of the escitalopram group and none from the MBSR group due to adverse events. At least 1 study-related adverse event occurred for 110 participants randomized to escitalopram (78.6%) and 21 participants randomized to MBSR (15.4%). Conclusions and Relevance: The results from this randomized clinical trial comparing a standardized evidence-based mindfulness-based intervention with pharmacotherapy for the treatment of anxiety disorders found that MBSR was noninferior to escitalopram. Trial Registration: ClinicalTrials.gov Identifier: NCT03522844.

Investigating the Role of Interpretation Bias in Mindfulness-Based Treatment of Adults With Generalized Anxiety Disorder.

Although mindfulness-based interventions (MBIs) have garnered empirical support for a wide range of psychological conditions, the psychological processes that mediate the relationship between MBIs and subsequent symptomatic improvement are less well-understood. In the present study we sought to examine, for the first time, the relationship between mindfulness, negative interpretation bias as measured by the homophone task, and anxiety among adults with Generalized Anxiety Disorder (GAD). Forty-two individuals with GAD completed measures of mindfulness, interpretation bias, and anxiety before and after treatment with Mindfulness-based Stress Reduction (MBSR). Contrary to prior research, we did not find evidence of an indirect relationship between baseline levels of mindfulness and anxiety via negative interpretation bias. MBSR did result in significant reductions in negative interpretation bias from baseline to post-treatment; however, we did not find evidence of an indirect relationship between changes in mindfulness and changes in anxiety via changes in interpretation bias. Taken together, these results provide minimal support for the hypothesized relationship between mindfulness, negative interpretation bias, and anxiety among adults with GAD. Limitations and specific suggestions for further inquiry are discussed.

Treatment for anxiety: Mindfulness meditation versus escitalopram (TAME): Design of a randomized, controlled non-inferiority trial.

Anxiety disorders (generalized anxiety disorder, social anxiety disorder, panic disorder, and agoraphobia) are common, distressing, and impairing. While pharmacotherapy and psychotherapy are first-line treatment strategies for anxiety disorders, many patients are reluctant to take psychiatric medication, and many prefer to avoid any kind of mental health treatment due to stigma or distrust of traditional medical care. We present the trial protocol for the first study comparing first-line medication treatment with Mindfulness-Based Stress Reduction (MBSR), a popular mindfulness meditation training program, for the treatment of anxiety disorders. We will use a non-inferiority, comparative effectiveness trial design, in which individuals with diagnosed anxiety disorders will be randomized to either pharmacotherapy with escitalopram or MBSR for 8 weeks of treatment. Treatment outcome will be based on gold standard symptom severity measures assessed by trained independent evaluators blind to treatment allocation. Secondary outcomes will include key symptom and function measures, as well as tolerability and satisfaction with treatment. Findings will provide crucial information to inform decision making about the relative benefits of MBSR versus a first line medication for anxiety disorders by patients, medical care providers, healthcare insurers and other stakeholders.

Effects of mindfulness meditation on occupational functioning and health care utilization in individuals with anxiety.

OBJECTIVES: To examine the effect of mindfulness meditation on occupational functioning in individuals with Generalized anxiety disorder (GAD). METHODS: Fifty-seven individuals with GAD (mean (SD) age=39 (13); 56% women) participated in an 8-week clinical trial in which they were randomized to mindfulness-based stress reduction (MBSR) or an attention control class. In this secondary analysis, absenteeism, entire workdays missed, partial workdays missed, and healthcare utilization patterns were assessed before and after treatment. RESULTS: Compared to the attention control class, participation in MBSR was associated with a significantly greater decrease in partial work days missed for adults with GAD (t=2.734, df=51, p=0.009). Interestingly, a dose effect was observed during the 24-week post-treatment follow-up period: among MBSR participants, greater home mindfulness meditation practice was associated with less work loss and with fewer mental health professional visits. CONCLUSION: Mindfulness meditation training may improve occupational functioning and decrease healthcare utilization in adults with GAD.

Open Mind, Open Heart: An Anthropological Study of the Therapeutics of Meditation Practice in the US.

Based on ethnographic fieldwork and interviews collected with meditation teachers and students in the United States, this article will argue that active training in meditation-based practices occasions the opportunity for people with traumatic stress to develop a stronger mind-body connection through heightened somatic awareness and a focus on the present moment that they find to be therapeutic. Three important themes related to healing through meditation for trauma emerged from the data and centered around the ways our interlocutors attempted to realign their sense of self, mind and body, after a traumatic experience. The themes helped explain why US women perceive meditation as therapeutic for trauma, namely that the practice of meditation enables one to focus on the lived present rather than traumatic memories, to accept pain and "open" one's heart, and to make use of silence instead of speech as a healing modality. As meditation practices increasingly enter global popular culture, promoted for postulated health benefits, the driving question of this research--how meditation may perpetuate human resilience for women who have experienced trauma based on their own perspectives of meditation practices--is a critical addition to the literature.

Mindfulness-Based Stress Reduction for Low-Income, Predominantly African American Women With PTSD and a History of Intimate Partner Violence.

In this article, we consider the use of Mindfulness-Based Stress Reduction (MBSR) (Kabat-Zinn, 1991) as a community-based intervention to reduce health disparities for low-income, predominantly African American women with a history of intimate partner violence (IPV) and posttraumatic stress disorder (PTSD). This article presents our rationale for using MBSR as an intervention with this population, the details of its implementation, and a discussion of the feasibility and acceptability of the intervention based on participants' feedback and our observations. We conclude that the use of MBSR programs for low-income, predominantly African American women with PTSD and a history of IPV is both feasible (of initial interest to and completed by most participants) and acceptable (congruent with and relevant to their needs). Replication with larger samples and examination of mechanisms is warranted by these findings.

A qualitative analysis of beginning mindfulness experiences for women with post-traumatic stress disorder and a history of intimate partner violence.

This article presents the beginning mindfulness experiences of low income, minority women with a history of intimate partner violence. Ten women participated in a Mindfulness-Based Stress Reduction group, three interviews and a focus group over 15 months. Using an interpretive phenomenological analysis approach, we derived the following themes: struggles to practice meditation; a vision of growing and helping; personal improvements, and interpersonal improvements. We share recommendations for clinical practice.

Ethnic differences in battered women's formal help-seeking strategies: a focus on health, mental health, and spirituality.

The primary goal of this study was to identify ethnic differences in battered women's use of health, mental health, and spiritual coping strategies, as well as differences in the perceived helpfulness of each strategy. The authors recruited a sample of 376 African American and Caucasian victims of interpersonal violence from various sites. In comparison with Caucasian women in the sample, African American women were significantly more likely to report using prayer as a coping strategy and significantly less likely to seek help from mental health counselors. The 2 groups did not significantly differ in terms of the extent to which they sought help from clergy or medical professionals. African American women found prayer to be more helpful than did Caucasian women.