A Mindfulness Intervention Noninferior to Escitalopram Among Patients With Anxiety

An intervention of mindfulness-based stress reduction was found to be noninferior to escitalopram among patients with anxiety disorders.

A mindfulness-based stress reduction (MBSR) intervention was found to be noninferior to escitalopram among patients with anxiety disorders. These findings were published in JAMA Psychiatry.

The Treatments for Anxiety: Medication and Escitalopram (TAME) study was a prospective, randomly assigned, single-blind, 2-arm, parallel-group, controlled trial conducted at 3 sites in the United States from 2018 to 2020. Patients (N=276) with generalized anxiety disorder (GAD), social anxiety disorder (SAD), panic disorder, or agoraphobia were randomly assigned to receive 8 weeks of MBSR (n=136) or 10-20 mg escitalopram (n=140). The MBSR intervention comprised eight 2.5-hour sessions, a weekend retreat at week 5 or 6, and 45-minute daily home practice in which patients practiced mindfulness meditation techniques, such as breathing, focusing on body parts, and mindful movement. The primary outcome was the change in Clinical Global Impression of Severity scale (CGI-S) scores and the noninferiority margin was defined as -0.495 points.

The MBSR and escitalopram cohorts included patients with a mean [SD] age of 33 [12] and 33 [13] years, who were primarily women (74% and 76%), and had comorbidities, including high severity anxiety (50% and 50%), generalized anxiety disorder (62% and 61%), and SAD (21% and 32%), respectively. In patients with comorbid psychiatric conditions, MBSR was noninferior to escitalopram in patients with SAD (P =.03), but was not noninferior in patients with major depressive disorder (P =.24), panic disorder (P =.30), agoraphobia (P =.30), and generalized anxiety disorder.

The proportion of patients who completed at least 6 MBSR sessions was 75% and the proportion of patients who took at least 6 weeks of escitalopram was 76.5%.

In this trial, an MBSR was shown to be a well-tolerated treatment option with comparable effectiveness to a first-line medication for patients with anxiety disorders.

Compared with baseline, CGI-S scores had improved at week 8 by an average of 1.35 (SD, 1.06) points among the MBSR recipients compared with 1.43 (SD, 1.17) points among the escitalopram recipients. The between-group difference did not reach significance (mean difference [MD], -0.07; 95% CI, -0.38 to 0.23; P =.65) and was within the noninferiority threshold.

Similarly, no group differences in CGI-S scores were observed at 12 (MD, -0.07; standard error [SE], 0.15; P =.67) or 24 (MD, 0.00; SE, 0.16; P =1) weeks.

Outcomes did not differ from the main analysis in sensitivity analyses or after imputing missing data.

No serious adverse events were reported. However, more escitalopram recipients reported any study-related adverse event compared with MBSR recipients (78.6% vs 15.4%; P <.001), respectively. The most common events in the escitalopram cohort included sleep disturbance (41%), nausea (35%), fatigue (26%), headache (18%), somnolence (14%), and anorgasmia or delayed orgasm (11%).

This study may have been biased, as the MBSR group spent more time engaging in treatment-related activities.

Study authors concluded, “In this trial, an MBSR was shown to be a well-tolerated treatment option with comparable effectiveness to a first-line medication for patients with anxiety disorders. Problematic habitual thought patterns characterize anxiety disorders, and mindfulness training specifically focuses the mind on the present moment; thus, individuals practice seeing thoughts and sensations as merely transient mental phenomena and not necessarily accurate reflections of reality.”

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

References:

Hoge EA, Bui E, Mete M, Dutton MA, Baker AW, Simon NM. Mindfulness-based stress reduction vs escitalopram for the treatment of adults with anxiety disorders: a randomized clinical trial. JAMA Psychiatry. 2022;e223679. doi:10.1001/jamapsychiatry.2022.3679