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Randomized Controlled Trial
. 2023 Jan 1;80(1):13-21.
doi: 10.1001/jamapsychiatry.2022.3679.

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

Elizabeth A Hoge  1 , Eric Bui  2 , Mihriye Mete  3 , Mary Ann Dutton  1 , Amanda W Baker  4 , Naomi M Simon  5
Affiliations
Randomized Controlled Trial

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

Elizabeth A Hoge et al. JAMA Psychiatry. .

Abstract

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Bui reports grants from the National Institutes of Health and the US Department of Defense, licenses or royalties from Springer and Wolters Kluwyer, and consulting fees from Cereval Therapeutics. In the past 3 years, Dr Simon reports grants from the American Foundation for Suicide Prevention, the US Department of Defense, the Patient-Centered Outcomes Research Institute, the National Institutes of Health, and Cohen Veterans Network; grants from the New York University Innovation Fund (partial support for mindfulness-based stress reduction classes and escitalopram during the conduct of the study); consulting fees from Engrail Therapeutics, Bionomics Limited, BehavR LLC, Vanda Pharmaceuticals, Praxis Therapeutics, Cerevel, Genomind, and Wiley (deputy editor Depression and Anxiety); royalty fees from Wolters Kluwer (UpToDate), APA Publishing (Textbook of Anxiety, Trauma and OCD Related Disorders, 2020); and spousal equity in G1 Therapeutics and Zentalis outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Diagram
MBSR indicates mindfulness-based stress reduction.
Figure 2.
Figure 2.. Noninferiority Diagram
Effect sizes and noninferiority confidence intervals of primary outcome for mindfulness-based stress reduction (MBSR) vs escitalopram (week 8 end point). Difference is the improvement in MBSR minus improvement in escitalopram. Shaded region indicates region of noninferiority. ITT indicates intent-to-treat; PP, per-protocol.
Figure 3.
Figure 3.. Longitudinal Data
Predicted Clinical Global Impression Severity scale (CGI-S) score based on a linear mixed model adjusted by age, sex, race, site, and total number of secondary diagnoses. MBSR indicates mindfulness-based stress reduction.
See this image and copyright information in PMC

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