Treating Major Depression With Yoga Mono-therapy

November 4, 2025 updated by: University of California, San Francisco

Treating Major Depression With Yoga Mono-therapy: 12-Week Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • Recruiting
        • Zuckerberg San Francisco General Hospital
        • Contact:
        • Principal Investigator:
          • Sudha Prathikanti, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yoga practice
Yoga practice groups
Behavioral: Yoga practice
90-minute group yoga classes twice weekly for 12 weeks.
Active Comparator: Education
Education module group
Behavioral: Education
90-minute group education classes twice weekly for 12 weeks to learn holistic healthcare modules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Beck Depression Inventory-II score
Time Frame: 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.
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in methylation of the GrimAge epigenetic clock
Time Frame: Baseline and 12 weeks
Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks.
Baseline and 12 weeks
Change in transcription of the nuclear factor kappa-B (NF-κB) pathway
Time Frame: Baseline and 12 weeks
Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks.
Baseline and 12 weeks
Change in plasma interleukin-6 (IL-6) level
Time Frame: Baseline and 12 weeks
Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks.
Baseline and 12 weeks
Change in telomere length of leukocytes
Time Frame: Baseline and 12 weeks
Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks.
Baseline and 12 weeks
Change in plasma brain-derived neurotropic factor (BDNF) level
Time Frame: Baseline and 12 weeks
Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks.
Baseline and 12 weeks
Change in Perceived Stress Scale score
Time Frame: 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.
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Sudha Prathikanti, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

October 13, 2023

First Submitted That Met QC Criteria

October 13, 2023

First Posted (Actual)

October 19, 2023

Study Record Updates

Last Update Posted (Estimated)

November 6, 2025

Last Update Submitted That Met QC Criteria

November 4, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-38755

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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