Summary: A randomized clinical trial found that an eight-week mindfulness-based stress reduction program (MBSR) was as effective as the commonly prescribed antidepressant escitalopram for reducing symptoms in adults with anxiety disorders.
Source: Georgetown University Medical Center
In a first-of-its-kind randomized clinical trial, researchers at Georgetown University Medical Center report that a guided mindfulness-based stress reduction (MBSR) program produced reductions in anxiety symptoms comparable to those achieved with escitalopram, a widely used first-line antidepressant.
The results were published in JAMA Psychiatry on November 9, 2022, following new recommendations from the United States Preventive Services Task Force to screen more broadly for anxiety disorders because of their high prevalence and significant impact on health and functioning.
“These findings support offering MBSR as a legitimate, evidence-based treatment option for anxiety disorders,” says Elizabeth Hoge, MD, director of the Anxiety Disorders Research Program and associate professor of psychiatry at Georgetown, who led the study. “Mindfulness programs can be delivered outside medical settings and do not require clinicians with advanced clinical degrees to train facilitators, which helps expand access.”
Anxiety disorders—including generalized anxiety disorder, social anxiety disorder, panic disorder, and specific phobias—are common and often disabling. While pharmacological treatments like selective serotonin reuptake inhibitors (SSRIs) can be effective, barriers such as limited access, nonresponse for some patients, and medication side effects (for example, nausea, sexual dysfunction, and drowsiness) can limit their usefulness.
Standardized mindfulness interventions such as MBSR have been shown to reduce anxiety symptoms, but until this trial they had not been directly compared with a proven anti-anxiety medication in a randomized design.
Between June 2018 and February 2020, the research team enrolled 276 adults diagnosed with an anxiety disorder from three academic centers in Boston, New York City, and Washington, D.C. Participants were randomized to one of two treatments: an eight-week MBSR course or flexible-dose escitalopram (10–20 mg).
The MBSR course consisted of weekly in-person classes lasting two and a half hours, a full-day retreat held during week five or six, and a daily 45-minute home practice routine. Anxiety severity was assessed at baseline, at the eight-week endpoint, and again at 12 and 24 weeks. Trained evaluators who conducted outcome assessments were blinded to participants’ treatment assignments.
A total of 208 participants completed the primary phase of the trial: 102 in the MBSR group and 106 in the escitalopram group. The study population had a mean age of 33 years and was 75% female, reflecting the higher prevalence of anxiety disorders among women. Baseline severity on the Clinical Global Impression of Severity scale (CGI-S) averaged about 4.5 in both groups.
Both treatment groups experienced meaningful reductions in anxiety. At the eight-week endpoint, MBSR participants improved by a mean of 1.35 points on the CGI-S, while the escitalopram group improved by 1.43 points. The between-group difference (−0.07) was within the study’s predefined noninferiority margin, indicating that MBSR was statistically noninferior to escitalopram. This improvement represents roughly a 30% reduction in overall symptom severity for participants in both groups.
Adverse events differed between groups. Of those who began treatment, 10 participants (8%) discontinued escitalopram because of adverse effects, while no one discontinued the MBSR program for that reason. Study-related adverse events were reported in 78.6% of those randomized to escitalopram versus 15.4% in the MBSR group.
Participants reported practical benefits from MBSR. Olga Cannistraro, a study participant, described how the program changed her relationship to worrying: “MBSR taught me to notice my anxious reactions and then choose how to respond. It wasn’t an instant cure, but it was a lifelong skill that helped reverse the course of my anxiety.”
Hoge notes that MBSR requires participant commitment to attend sessions and practice between classes, which contributes to its effectiveness. She also observes that virtual delivery via videoconference may retain effectiveness if live interaction—such as group discussion and instructor-led Q&A—is maintained. The relative benefits of meditation phone apps compared with the structured, instructor-led MBSR course remain uncertain and require further study.
Most participants completed their eight-week treatment before the COVID-19 pandemic began. The research team later adapted both interventions for online delivery and plans additional analyses to evaluate outcomes from the videoconference phase. Future research will also examine how MBSR affects related conditions such as sleep problems and depression.
About this mindfulness and anxiety research news
Author: Press Office
Source: Georgetown University Medical Center
Contact: Press Office – Georgetown University Medical Center
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Original Research: Closed access. “Mindfulness-Based Stress Reduction vs Escitalopram for the Treatment of Adults With Anxiety Disorders: A Randomized Clinical Trial” by Elizabeth A. Hoge et al., JAMA Psychiatry
Abstract
Mindfulness-Based Stress Reduction vs Escitalopram for the Treatment of Adults With Anxiety Disorders: A Randomized Clinical Trial
Importance Anxiety disorders are common and often severely impairing. While effective treatments exist, many patients do not access or do not respond to them. Mindfulness-based interventions such as MBSR are popular and can lower anxiety, but how they compare with standard first-line pharmacological treatments was previously unknown.
Objective To determine whether an eight-week MBSR program is noninferior to escitalopram, a commonly used SSRI for anxiety disorders.
Design, Setting, and Participants The TAME randomized clinical trial enrolled participants from June 2018 to February 2020 at three urban academic medical centers in the United States. Blinded clinical evaluators assessed outcomes at baseline, week 8 (end point), and follow-ups at weeks 12 and 24. Of 430 individuals screened, 276 adults with a diagnosed anxiety disorder were randomized; 208 completed the primary phase of the trial.
Interventions Participants were randomized 1:1 to eight weeks of MBSR (weekly in-person group classes, a retreat day, and daily home practice) or escitalopram dosed flexibly from 10 to 20 mg.
Main Outcomes and Measures The primary outcome was anxiety severity measured with the Clinical Global Impression of Severity scale (CGI-S), with a prespecified noninferiority margin of −0.495 points.
Results The per-protocol analysis included 208 patients (102 MBSR, 106 escitalopram). Mean (SD) age was 33 (13) years; 75% were female. Baseline mean CGI-S scores were approximately 4.5 in both groups. At end point, mean CGI-S scores decreased by 1.35 (1.06) points for MBSR and 1.43 (1.17) points for escitalopram. The between-group difference met the prespecified criterion for noninferiority (difference −0.07; 95% CI, −0.38 to 0.23). Secondary intent-to-treat analyses with imputed data supported the noninferiority finding. Ten participants (8%) discontinued escitalopram because of adverse events; no participants discontinued MBSR for adverse events. Study-related adverse events were reported for 78.6% of those randomized to escitalopram and 15.4% of those randomized to MBSR.
Conclusions and Relevance In this randomized clinical trial, an evidence-based MBSR program was noninferior to escitalopram for reducing anxiety severity in adults with anxiety disorders, suggesting MBSR is a viable treatment option for many patients.
Trial Registration ClinicalTrials.gov Identifier: NCT03522844