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.

Facets of Mindfulness in Adults with Generalized Anxiety Disorder and Impact of Co-occurring Depression.

Anxiety and depressive symptoms are associated with lower levels of mindfulness, yet few studies to date have examined facets of mindfulness in adults with Generalized Anxiety Disorder (GAD). In this study, we examined differences in mindfulness between individuals with GAD with and without concurrent Major Depressive Disorder (MDD) and/or Dysthymic Disorder (DD). We also examined the associations of anxiety and depressive symptoms with facets (subscales) of mindfulness. We hypothesized that individuals with primary GAD and co-occurring MDD/DD would exhibit lower mindfulness than those without a concurrent depressive disorder. We also hypothesized that mindfulness would be negatively correlated with worry and depressive symptom severity. Subjects were 140 adults (M (SD) age = 33.4 (12.9); 73% female) with a primary diagnosis of GAD; 30.8% (n = 43) also met criteria for current MDD/DD as determined by a structured clinical interview for DSM-IV. Current worry and depressive symptoms were assessed using self-report measures at baseline of a 12-week treatment study. Individuals with GAD and co-occurring MDD/DD exhibited significantly lower mindfulness than those without a depressive disorder diagnosis and specifically lower scores on the Awareness sub-scale compared to individuals with primary GAD and no comorbid depression. In terms of the dimensional impact of worry and depression ratings, depression symptoms independently predicted lower Awareness scores and worry independently predicted lower levels of Nonreacting and Nonjudging sub-scales. This may have direct treatment implications.