RecruitingRecruiting
Treating Major Depression With Yoga Mono-therapy
NCT06091527 · University of California, San Francisco
In plain English
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Official title
Treating Major Depression With Yoga Mono-therapy: 12-Week Randomized Controlled Trial
About this study
Consenting participants will be randomized equally to one of three in-person group interventions for 12 weeks: Standard yoga practice, Ayurvedic yoga practice, or educational attention-control modules. The primary outcome is depression severity, measured by Beck Depression Inventory-II (BDI) scores. Secondary outcomes include perceived stress, measured by Perceived Stress Scale (PSS) scores, and several biomarker assays associated with depression: methylation of the GrimAge epigenetic clock, nuclear factor kappa-B (NF-κB) transcription, leucocyte telomere length, interleukin-6 (IL-6) and brain-derived neurotropic factor (BDNF). Blinded assessors will conduct all outcome analyses at 12 weeks. The primary analysis will test whether the yoga groups combined achieve statistically greater change in BDI scores compared to the control group. Secondary analyses will test whether the yoga groups combined, compared to the control group, demonstrate statistically greater change in PSS scores and the aforementioned biomarker assays. In sub-analyses, investigators will assess whether Ayurvedic yoga participants, compared to Standard yoga participants, demonstrate statistically significant improvements in BDI scores, PSS scores, and depression biomarker assays over the 12-week intervention period.
Eligibility criteria
Inclusion criteria:
* 18 years of age or older
* Able to give voluntary, informed consent
* English-speaking
* Diagnosis of clinical depression
Exclusion criteria:
* Current use of antidepressant medication
* Current engagement in psychotherapy
* Current pregnancy
* Significant medical issues interfering with yoga practice
Study design
Enrollment target: 180 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2024-10-25
Estimated completion: 2026-06
Last updated: 2025-11-06
Interventions
Behavioral: Yoga practiceBehavioral: Education
Primary outcomes
- • Change in Beck Depression Inventory-II score (Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks)
Sponsor
University of California, San Francisco · other
Contacts & investigators
ContactSudha Prathikanti, MD · contact · sudha.prathikanti@ucsf.edu · 415-516-3867
InvestigatorSudha Prathikanti, MD · principal_investigator, University of California, San Francisco
All locations (1)
Zuckerberg San Francisco General HospitalRecruiting
San Francisco, California, United States