Depression Mild, Depression Moderate
Conditions
Keywords
yoga, ayurveda, depression
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.
Interventions
BEHAVIORALYoga practice
90-minute group yoga classes twice weekly for 12 weeks.
BEHAVIORALEducation
90-minute group education classes twice weekly for 12 weeks to learn holistic healthcare modules.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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. |
| 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 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. |
Countries
United States
Contacts
Primary ContactSudha Prathikanti, MD
Outcome results
None listed