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NCT Number: NCT06091527

Treating Major Depression With Yoga Mono-therapy

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.

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Key information

Conditions

Depression Mild Behavior Behavioral Symptoms Depression Depression Moderate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location status: Recruiting

Location contact

Sudha Prathikanti, MD

CONTACT

[email protected]

415-516-3867

Sudha Prathikanti, MD

PRINCIPAL_INVESTIGATOR

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yoga practice

Behavioral

90-minute group yoga classes twice weekly for 12 weeks.

Education

Behavioral

90-minute group education classes twice weekly for 12 weeks to learn holistic healthcare modules.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sudha Prathikanti, MD

CONTACT

[email protected]

415-516-3867

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 19, 2023
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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