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Treating Major Depression With Yoga Mono-therapy

ConditionsDepression MildDepression Moderate
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older

Able to give voluntary, informed consent

English-speaking

Diagnosis of clinical depression

Disqualifiers

Current use of antidepressant medication

Current engagement in psychotherapy

Current pregnancy

Significant medical issues interfering with yoga practice

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Yoga practiceExperimental treatment 1 intervention
Group B: EducationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Beck Depression Inventory-II score

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.

Time frame
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks

Secondary outcomes

1

Change in Perceived Stress Scale score

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.

Time frame
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks
2

Change in methylation of the GrimAge epigenetic clock

Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks.

Time frame
Baseline and 12 weeks
3

Change in transcription of the nuclear factor kappa-B (NF-κB) pathway

Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks.

Time frame
Baseline and 12 weeks
4

Change in plasma interleukin-6 (IL-6) level

Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks.

Time frame
Baseline and 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Source ClinicalTrials.gov
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