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Treating Major Depression With Yoga Mono-therapy

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ClinicalTrials.gov Identifier: NCT06091527
Recruitment Status : Not yet recruiting
First Posted : October 19, 2023
Last Update Posted : October 19, 2023
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Depression Mild Depression Moderate Behavioral: Yoga practice Behavioral: Education Phase 2

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 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Major Depression With Yoga Mono-therapy: 12-Week Randomized Controlled Trial
Estimated Study Start Date : November 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Reduction in Beck Depression Inventory-II score [ Time Frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks ]
    The BDI 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 BDI 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 BDI 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 Outcome Measures :
  1. Reduction 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 originally developed by Cohen et al in 1983. It is widely 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. Reduction 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. The methylation level of the GrimAge epigenetic clock will be measured in a specimen of whole blood that has been collected in acid citrate dextrose (ACD) yellow top tube. The estimated blood volume needed is 8.5 ml per participant and measurement.

  3. Reduction 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. The transcription level of the nuclear factor kappa-B (NF-κB) pathway will be measured in a specimen of whole blood that has been collected in a PAXgene tube with reagent for stabilization of intracellular RNA. The estimated blood volume needed is 2.5 ml per participant and measurement.

  4. Reduction in serum 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. The serum level of Interleukin-6 (IL-6) will be measured in a specimen of whole blood that has been collected in a Serum Separator Tube (SST) Gold Top vs plain Red Top. The estimated blood volume needed is 6-7 ml per participant and measurement.

  5. Increase 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. The telomere length of leukocytes will be measured in a specimen of whole blood that has been collected in a EDTA anticoagulant Lavender top tube. The estimated blood volume needed is 3 ml per participant and measurement.

  6. Increase in serum telomerase level [ Time Frame: Baseline and 12 weeks ]
    Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks. The serum telomerase level will be measured in a specimen of whole blood that has been collected in a EDTA anticoagulant Lavender top tube. The estimated blood volume needed is 3 ml per participant and measurement.

  7. Increase in serum 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. The serum level of brain-derived neurotropic factor (BDNF) will be measured in a specimen of whole blood that has been collected in Serum Separator Tube (SST) Gold Top vs plain Red Top. The estimated blood volume needed is 6-7 ml per participant and measurement.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06091527


Contacts
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Contact: Sudha Prathikanti, MD 415-516-3867 sudha.prathikanti@ucsf.edu

Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Sudha Prathikanti, MD University of California, San Francisco
More Information
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Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT06091527    
Other Study ID Numbers: 23-38755
First Posted: October 19, 2023    Key Record Dates
Last Update Posted: October 19, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
yoga
ayurveda
depression
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders