Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Sudha Prathikanti, MD (ucsf)
Headshot of Sudha Prathikanti
Sudha Prathikanti

Description

Summary

The goal of this single-center, single-blind, randomized, controlled, parallel group, interventional trial 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 a an education control intervention on holistic healthcare.

Official Title

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

Details

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 severity: methylation of the GrimAge epigenetic clock, nuclear factor kappa-B (NF-κB) transcription, leucocyte telomere length, and serum levels of telomerase, 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 reduction 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: reduction in PSS scores, reduction in methylation of the GrimAge epigenetic clock, reduction in NF-κB transcription, reduction in serum IL-6, increase in leucocyte telomere length, increase in serum telomerase, and increase in serum BDNF. In sub-analyses, we 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.

Keywords

Depression Mild, Depression Moderate, yoga, ayurveda, depression, Depressive Disorder, Yoga practice, Education

Eligibility

You can join if…

Open to people ages 18 years and up

  • 18 years of age or older
  • All gender identities
  • All ethnicities
  • Able to give voluntary, informed consent
  • English proficiency sufficient for study participation
  • Living near San Francisco during study, and able to attend all required visits for study participation
  • Clinical diagnosis of major depression per screening Mini International Neuro-psychiatric Interview
  • Depression symptoms of mild to moderate severity, per score of 14-28 on screening Beck
  • Depression Inventory-II

You CAN'T join if...

  • Use of antidepressant medication during the study period, or during the 2 months prior to study period (at screening, individuals who report being in treatment with antidepressant medication will not be asked to discontinue medication; instead, these individuals will be excluded from study participation)
  • Use of psychotherapy during the study period (at screening, individuals who report being in psychotherapy will not be asked to discontinue psychotherapy; instead, these individuals will be excluded from study participation)
  • Use of any yoga exercises, other than study intervention, during the study period
  • Cognitive Impairment (score < 24 on screening Folstein Mental Status Exam)
  • Diagnosis of active substance use disorder currently or during the 2 months prior to screening interview
  • Diagnosis of bipolar disorder or any other serious mental illness, other than major depression, per screening Mini International Neuro-psychiatric Interview
  • Severe major depression, per score > 28 on screening Beck Depression Inventory-II
  • History of suicide attempts, suicidal ideation, or psychosis
  • Pregnancy
  • Seizure disorder
  • Carotid artery stenosis
  • Uncontrolled hypertension
  • Severe pulmonary disease
  • Severe musculoskeletal problems likely to interfere with 12 weeks of study participation.
  • Other medical conditions with acute somatic or constitutional symptoms (such as fever, vertigo, nausea, severe fatigue, severe pain) present at the time of screening and likely to interfere with 12 weeks of study participation.

Location

  • University of California San Francisco
    San Francisco California 94115 United States

Lead Scientist at University of California Health

  • Sudha Prathikanti, MD (ucsf)
    Sudha Prathikanti, MD, is Board-certified in Adult Psychiatry, a diplomate of the American Board of Integrative Holistic Medicine, and a certified Ayurvedic practitioner. At the UCSF Osher Center for Integrative Medicine, she founded both the Integrative Psychiatry and the Ayurveda consultation services, and currently directs the Integrative Psychiatry Teaching Clinic at this site.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06091527
Phase
Phase 2 Depression Research Study
Study Type
Interventional
Participants
Expecting 180 study participants
Last Updated