Cited by 95Anxiety, Depression, Psychometrics, Treatment, Cognitive ProcessesMindfulness and Compassion InterventionsPsychotherapy Techniques and Applications

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

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Simon, Naomi M., Hofmann, Stefan G., Rosenfield, David, Hoeppner, Susanne S., Hoge, Elizabeth A., Bui, Eric, Khalsa, Sat Bir S.·2021·JAMA Psychiatry

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.

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  • In Simon et al., at 6-month follow-up, the CBT response rate (76.7%) was significantly higher than the SE group (48%), with an NNT of 3.51.

    “At 6-month follow-up, the CBT response rate (76.7%) was significantly higher than the SE group (48%), with a NNT of 3.51.”
  • In Simon et al., the Kundalini yoga (KY) group had a significantly higher response rate (54.2%) than the stress education (SE) group (33%) at posttreatment, with a number needed to treat (NNT) of 4.59.

    “The KY group had a significantly higher response rate (54.2%) than the SE group (33%) at posttreatment, with a number needed to treat (NNT) of 4.59.”
  • CBT and KY were both more effective than SE as assessed by short-term response rates.

    “CBT and KY were both more effective than SE as assessed by short-term response rates.”
  • In Simon et al., at 6-month follow-up, the response rate in the KY group was not significantly higher than that of the SE group.

    “At 6-month follow-up, the response rate in the KY group was not significantly higher than that of the SE group.”
  • CBT appeared to have better long-term response outcomes compared to SE, while KY did not display a benefit in follow-up analyses.

    “CBT appeared to have better long-term response outcomes compared to SE, while KY did not display a benefit in follow-up analyses.”

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Authors
Simon, N. M., Hofmann, S. G., Rosenfield, D., Hoeppner, S. S., Hoge, E. A., Bui, E., & Khalsa, S. B. S.
Affiliations
  • New York University (US)
  • Boston University (US)
  • Southern Methodist University (US)
  • Harvard University (US)
  • Georgetown University Medical Center (US)
  • Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston
  • Brigham and Women's Hospital (US)
Corresponding author
Simon, Naomi M.
Venue
JAMA Psychiatry
Published
2021-01-01
Volume
78
Issue
1
Pages
13
ISSN
2168-622X (ISSN-L)
OpenAlex
W3048917165
Cited by
95
References
38
Citations by year
2026: 8 · 2025: 19 · 2024: 14 · 2023: 16 · 2022: 24 · 2021: 11 · 2020: 3
FWCI
13.06
Type
journal article
Language
en
Open access
Locations
  • JAMA Psychiatry (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • National Institutes of Health
  • National Center for Complementary and Integrative Health (R01AT007257, R01AT007258)
Topics
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
  • Social Sciences › Psychology › Clinical Psychology › Mindfulness and Compassion Interventions
  • Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
Keywords
generalized anxiety disorder, Kundalini yoga, cognitive behavioral therapy, stress education, non-inferiority, complementary and alternative medicine, treatment efficacy comparison, treatment completion rate, dropout rates, adverse events, patient-reported outcomes, treatment acceptability
MeSH terms
Adult, Anxiety Disorders, Female, Humans, Male, Middle Aged, Patient Education as Topic, Stress, Psychological, Yoga, Cognitive Behavioral Therapy, Single-Blind Method, Outcome Assessment, Health Care, Young Adult

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