Efficacy of Yoga vs Cognitive Behavioral Therapy vs Stress Education for the Treatment of Generalized Anxiety Disorder: A Randomized Clinical Trial

Abstract

Importance: Generalized anxiety disorder (GAD) is common, impairing, and undertreated. Although many patients with GAD seek complementary and alternative interventions, including yoga, data supporting yoga's efficacy or how it compares to first-line treatments are lacking.

Objectives: To assess whether yoga (Kundalini yoga) and cognitive behavioral therapy (CBT) for GAD are each more effective than a control condition (stress education) and whether yoga is noninferior to CBT for the treatment of GAD.

Design, setting, and participants: For this randomized, 3-arm, controlled, single-blind (masked independent raters) clinical trial, participants were recruited from 2 specialty academic centers starting December 1, 2013, with assessment ending October 25, 2019. Primary analyses, completed by February 12, 2020, included superiority testing of Kundalini yoga and CBT vs stress education and noninferiority testing of Kundalini yoga vs CBT.

Interventions: Participants were randomized to Kundalini yoga (n = 93), CBT for GAD (n = 90), or stress education (n = 43), which were each delivered to groups of 4 to 6 participants by 2 instructors during twelve 120-minute sessions with 20 minutes of daily homework.

Main outcomes and measures: The primary intention-to-treat outcome was acute GAD response (Clinical Global Impression-Improvement Scale score of much or very much improved) after 12 weeks as assessed by trained independent raters.

Results: Of 538 participants who provided consent and were evaluated, 226 (mean [SD] age, 33.4 [13.5] years; 158 [69.9%] female) with a primary diagnosis of GAD were included in the trial. A total of 155 participants (68.6%) completed the posttreatment assessment. Completion rates did not differ (Kundalini yoga, 60 [64.5%]; CBT, 67 [74.4%]; and stress education, 28 [65.1%]: χ2 = 2.39, df = 2, P = .30). Response rates were higher in the Kundalini yoga group (54.2%) than in the stress education group (33.%) (odds ratio [OR], 2.46 [95% CI, 1.12-5.42]; P = .03; number needed to treat, 4.59 [95% CI, 2.52-46.19]) and in the CBT group (70.8%) compared with the stress education group (33.0%) (OR, 5.00 [95% CI, 2.12-11.82]; P < .001; number needed to treat, 2.62 [95% CI, 1.91-5.68]). However, the noninferiority test did not find Kundalini yoga to be as effective as CBT (difference, 16.6%; P = .42 for noninferiority).

Conclusions and relevance: In this trial, Kundalini yoga was efficacious for GAD, but the results support CBT remaining first-line treatment.

Trial registration: ClinicalTrials.gov Identifier: NCT01912287.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Simon reported receiving grants from the National Institutes of Health (NIH) during the conduct of the study; receiving grants from the US Department of Defense, American Foundation for Suicide Prevention, Patient-Centered Outcomes Research Institute, Highland Street Foundation, and Janssen; receiving personal fees from Vanda, Axovant Sciences, Springworks, Praxis Therapeutics, Aptinyx, Genomind, Wiley, and the Massachusetts General Hospital (MGH) Psychiatry Academy; performing grant reviews for American Foundation for Suicide Prevention; receiving royalties for UpToDate contributions from Wolters Kluwyer; and having spousal stock from G1 Therapeutics outside the submitted work. Dr Hofman reported receiving grants from the National Center for Complementary and Integrative Health (NCCIH), NIH during the conduct of the study. Dr Rosenfield reported receiving grants and personal fees from the NCCIH, NIH during the conduct of the study. Dr Hoeppner reported receiving grants from the NCCIH, NIH and nonfinancial support from Mark Pollack during the conduct of the study and receiving grants from the American Cancer Society, the Executive Committee on Research at MGH, Telefonica Alpha Inc, and National Institute on Drug Abuse outside the submitted work. Dr Hoge reported receiving grants from the NIH during the conduct of the study. Dr Bui reported receiving grants from the NIH during the conduct of the study and receiving royalties from Springer and grants from the US Department of Defense, Osher Center for Integrative Medicine, and Elizabeth Dole Foundation outside the submitted work. Dr Khalsa reported receiving grants from the NCCIH, NIH during the conduct of the study; receiving grants and personal fees from Kundalini Research Institute and grants from Kripalu Center for Yoga & Health outside the submitted work; and being a practitioner and certified instructor in Kundalini yoga as taught by Yogi Bhajan.

Figures

Figure 1.. CONSORT Flow Diagram

The trial was performed at 2 sites with randomization distribution within site as follows. Site 1: Kundalini yoga (KY), n = 49; cognitive behavior therapy (CBT), n = 42; and stress education (SE), n = 24. Site 2: KY, n = 44, CBT, n = 48; and SE, n = 19. All randomized participants were included in the primary analyses.

Figure 2.. Change in Treatment Response Rate Over Time

Response rates are based on a Clinical Global Impressions–Improvement Scale score of 1 or 2. CBT indicates cognitive behavioral therapy; KY, Kundalini yoga; and SE, stress education.

Figure 3.. Mediation Model

Response rates are based on a Clinical Global Impressions–Improvement Scale score of 1 or 2. Mean refers to the mean of that questionnaire over all its assessments during the treatment phase. Changes refer to the deviation of scores on that questionnaire from the mean on that questionnaire at each assessment point. We did not examine the mean level of Five Facet Mindfulness Questionnaire (FFMQ) or Metacognitions Questionnaire (MCQ) as mediators because mean levels were confounded by the third variable between-participant differences. Only significant path coefficients are shown. Absent path coefficients were not significant. CBT indicates cognitive behavioral therapy; KY, Kundalini yoga; and SE, stress education. aP < .05. bP < .01. cP < .005.