Mindfulness-Based Stress Reduction vs Escitalopram for the Treatment of Adults With Anxiety Disorders

Abstract

ImportanceAnxiety 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.ObjectiveTo determine whether MBSR is noninferior to escitalopram, a commonly used first-line psychopharmacological treatment for anxiety disorders.Design, Setting, and ParticipantsThis 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.InterventionsParticipants 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 MeasuresThe 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.ResultsThe 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 RelevanceThe 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 RegistrationClinicalTrials.gov Identifier: NCT03522844

Anxiety Disorders

“…MBCT and MBSR have significant short-term effects (defined as 2 months after randomization) on patient-rated anxiety, but may not be as effective as CBT . MBSR has been shown to be noninferior to the SSRI escitalopram on the Clinical Global Impression–Severity scale in a recent clinical trial of 276 adults with anxiety disorders (group difference, −0.07 [95% CI, −0.38 to 0.23], P = .65) . In 2 clinical trials, MBCT was associated with an SMD of −0.89 and in 4 clinical trials, MBSR was associated with an SMD of −1.42 compared with usual care …”

“…78 MBSR has been shown to be noninferior to the SSRI escitalopram on the Clinical Global Impression-Severity scale in a recent clinical trial of 276 adults with anxiety disorders (group difference, −0.07 [95% CI, −0.38 to 0.23], P = .65). 91 In 2 clinical trials, MBCT was associated with an SMD of −0.89 and in 4 clinical trials, MBSR was associated with an SMD of −1.42 compared with usual care. 89,90 Self-help and Mobile App-Based Interventions | Digital mental health (eg, internet-delivered therapy), mobile phone apps, and self-help interventions are increasingly available and may improve access to anxiety disorder treatment.…”

Healthcare Workers' Well-Being: A Systematic Review of Positive Psychology Interventions

“…These may be administered via different methods and have demonstrated effectiveness in multiple RCTs. One RCT found that an eight-week mindfulness-based stress reduction (MBSR) intervention was well-tolerated and of comparable effectiveness as the medication escitalopram in the treatment of generalized anxiety disorder [ 26 ].…”

Potential of Control Conditions for Nonspecific Treatment-Effects in Noninferiority Trials—Reply

“…In Reply We thank Budde et al for their important comment on our article and their suggestion to use a control condition to separate out the specific effects of mindfulness meditation in mindfulness-based stress reduction (MBSR) . We agree that MBSR probably has nonspecific treatment effects due to factors such as attention from the instructor, attention from the study team, time spent doing treatment-related activities, and social support and that these nonspecific treatment effects should be controlled for when examining efficacy.…”