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Are yoga and cognitive behavioral therapy (CBT) each more efficacious than a psychological control condition, and is yoga noninferior to CBT for the treatment of generalized anxiety disorder?
In this randomized clinical trial of 226 adults with generalized anxiety disorder, 12-week group treatment with either Kundalini yoga or CBT was more effective than the stress education control condition, but the noninferiority test did not find Kundalini yoga to be as effective as CBT.
Kundalini yoga can reduce anxiety for adults with generalized anxiety disorder, but study results support CBT remaining first-line treatment.
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.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT01912287
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Accepted for Publication: June 10, 2020.
Corresponding Author: Naomi M. Simon, MD, MSc, Department of Psychiatry, NYU Grossman School of Medicine, New York, NY 10016 (email@example.com).
Published Online: August 12, 2020. doi:10.1001/jamapsychiatry.2020.2496
Author Contributions: Drs Simon and Hofmann contributed equally to this work. Drs Simon and Hofmann had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Simon, Hofmann, Rosenfield, Hoge, Khalsa.
Acquisition, analysis, or interpretation of data: Simon, Hofmann, Rosenfield, Hoeppner, Hoge, Bui.
Drafting of the manuscript: Simon, Hofmann, Rosenfield, Khalsa.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Hofmann, Rosenfield, Hoeppner.
Obtained funding: Simon, Hofmann, Rosenfield, Khalsa.
Administrative, technical, or material support: Simon, Hofmann, Hoeppner, Hoge, Bui, Khalsa.
Supervision: Simon, Hofmann, Hoge, Bui, Khalsa.
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.
Funding/Support: This study was funded by grants 1R01AT007258 and 1R01AT007257 from the NCCIH, NIH (Drs Simon and Hofmann).
Role of the Funder/Sponsor: The NCCIH representatives gave feedback on the design and conduct of the study before study initiation and used a study monitor during the study. The NCCIH played no role in the collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 3.
Additional Contributions: We thank the practitioners, raters, research assistants, and study participants involved in this trial.
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