Introduction
Mindfulness-based interventions, such as mindfulness-based stress reduction (MBSR), have shown efficacy for anxiety disorders.1 We previously demonstrated that 8 weeks of MBSR was noninferior to escitalopram for treatment of anxiety disorders in a fully powered, multisite, noninferiority parallel-group randomized clinical trial with a predetermined margin.2 We present secondary outcomes of the trial, including patient-reported anxiety, depression, and quality of life (QOL)..
Discussion
In our previous trial, MBSR was noninferior to escitalopram based on a transdiagnostic clinician-rated primary outcome.2 To our knowledge, this secondary analysis is the first to describe patient-reported anxiety and depression outcomes and disorder-specific clinician-rated anxiety measures comparing mindfulness with pharmacotherapy. Overall, we were unable to detect significant between-group differences in outcomes, and the effect sizes were small (d = 0.01-0.20), suggesting a lack of clinically meaningful differences in effectiveness between treatments. At midtreatment but not study end, scores on a few measures indicated greater symptom reduction with escitalopram. Overall, our findings are consistent with previous work demonstrating the efficacy of mindfulness for panic and social anxiety disorders.4
This study has some limitations. Recipients of MBSR had more face-to-face time with their meditation instructor and prescriber. Additionally, noninferiority testing was not feasible with our sample size due to multiple secondary outcomes. Taken together, these findings support clinical application of MBSR to treat anxiety disorders, with outcomes similar to antidepressant pharmacotherapy but with potentially fewer side effects.Groups were compared using bivariate statistics and in multivariable regression analyses. Adjusted analyses used linear mixed models that included all participants at baseline regardless of missing data on other time points, according to intent-to-treat principle. Models were adjusted for sex, age, self-reported race and ethnicity (collected per National Institutes of Health requirements),2 baseline anxiety severity (low vs high), and site; included time and treatment indicators and their interactions; and were estimated with participant-level random effects. Between-group mean differences (MDs) were estimated for each time point. Analyses were conducted with Stata, version 15 (StataCorp LLC).
Discussion
In our previous trial, MBSR was noninferior to escitalopram based on a transdiagnostic clinician-rated primary outcome.2 To our knowledge, this secondary analysis is the first to describe patient-reported anxiety and depression outcomes and disorder-specific clinician-rated anxiety measures comparing mindfulness with pharmacotherapy. Overall, we were unable to detect significant between-group differences in outcomes, and the effect sizes were small (d = 0.01-0.20), suggesting a lack of clinically meaningful differences in effectiveness between treatments. At midtreatment but not study end, scores on a few measures indicated greater symptom reduction with escitalopram. Overall, our findings are consistent with previous work demonstrating the efficacy of mindfulness for panic and social anxiety disorders.4
This study has some limitations. Recipients of MBSR had more face-to-face time with their meditation instructor and prescriber. Additionally, noninferiority testing was not feasible with our sample size due to multiple secondary outcomes. Taken together, these findings support clinical application of MBSR to treat anxiety disorders, with outcomes similar to antidepressant pharmacotherapy but with potentially fewer side effects.
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2824672
2 Medical News 