Treating Major Depression With Yoga Mono-therapy

Not Applicable

Recruiting

• Conditions: Depression Mild; Depression Moderate
• Interventions: Behavioral: Education; Behavioral: Yoga practice

• Registration Number: NCT06091527
• Lead Sponsor: University of California, San Francisco

Brief Summary

The goal of this single-center, single-blind, randomized, controlled, parallel group, interventional trial is to evaluate antidepressant efficacy of yoga monotherapy of 12-weeks duration in 180 adults meeting diagnostic criteria for mild-to-moderate major depression at the Zuckerberg San Francisco General Hospital. Researchers will compare the yoga interventions to an education control intervention on holistic healthcare.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-10-13
• Study First Posted: 2023-10-19
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Study Start: 2024-09
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education	Education	Education module group
Yoga practice	Yoga practice	Yoga practice groups

Primary Outcome Measures

Name	Time	Method
Change in Beck Depression Inventory-II score	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks	The Beck Depression Inventory-II is one of the most commonly used instruments in psychiatric research; it has been translated and validated in many different languages, appearing in hundreds of studies worldwide. The Beck Depression Inventory-II is a 21-item validated instrument for the self-report of depressive symptoms; it can typically be completed in 5 minutes. Each item on the Beck Depression Inventory-II can be scored from 0 to 3, with the total score derived by summing the individual item scores. A total score of 14-19 suggests mild depression, 20-28 suggests moderate depression, and 29-63 suggests severe depression.

Secondary Outcome Measures

Name	Time	Method
Change in plasma interleukin-6 (IL-6) level	Baseline and 12 weeks	Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks.
Change in plasma brain-derived neurotropic factor (BDNF) level	Baseline and 12 weeks	Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks.
Change in methylation of the GrimAge epigenetic clock	Baseline and 12 weeks	Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks.
Change in Perceived Stress Scale score	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks	The Perceived Stress Scale is a commonly used instrument in psychiatric research; it has been translated and in many different languages, appearing in hundreds of studies worldwide. The Perceived Stress Scale is a 10-item validated questionnaire used to assess stress levels in individuals. It can typically be completed in 5 minutes and evaluates the degree to which an individual has perceived life as unpredictable, uncontrollable and overloading over the previous month. Each item on the Perceived Stress Scale can be scored 0 to 4, with the total score derived by summing the individual item scores. Higher scores indicate higher levels of perceived stress and there are no score cut-offs published by the developer.
Change in transcription of the nuclear factor kappa-B (NF-κB) pathway	Baseline and 12 weeks	Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks.
Change in telomere length of leukocytes	Baseline and 12 weeks	Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks.

Trial Locations

Locations (1)

Zuckerberg San Francisco General Hospital; 🇺🇸 San Francisco, California, United States