Back to resultsTreating Major Depression With Yoga Mono-therapy
Primary Purpose
Depression Mild, Depression Moderate
Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Yoga practice
Education
Sponsored by
About this trial
This is an interventional treatment trial for Depression Mild focused on measuring yoga, ayurveda, depression
Eligibility 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.
Sites / Locations
- University of California San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Yoga practice
Education
Arm Description
Yoga practice groups
Education module group
Outcomes
Primary Outcome Measures
Reduction in Beck Depression Inventory-II score
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
Reduction 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 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.
Reduction in methylation of the GrimAge epigenetic clock
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.
Reduction 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. 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.
Reduction in serum interleukin-6 (IL-6) level
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.
Increase in telomere length of leukocytes
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.
Increase in serum telomerase level
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.
Increase in serum brain-derived neurotropic factor (BDNF) level
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.
Full Information
NCT ID
NCT06091527
First Posted
October 13, 2023
Last Updated
October 13, 2023
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT06091527
Brief Title
Treating Major Depression With Yoga Mono-therapy
Official Title
Treating Major Depression With Yoga Mono-therapy: 12-Week Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression Mild, Depression Moderate
Keywords
yoga, ayurveda, depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Yoga practice
Arm Type
Experimental
Arm Description
Yoga practice groups
Arm Title
Education
Arm Type
Active Comparator
Arm Description
Education module group
Intervention Type
Behavioral
Intervention Name(s)
Yoga practice
Intervention Description
90-minute group yoga classes twice weekly for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
90-minute group education classes twice weekly for 12 weeks to learn holistic healthcare modules.
Primary Outcome Measure Information:
Title
Reduction in Beck Depression Inventory-II score
Description
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.
Time Frame
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks
Secondary Outcome Measure Information:
Title
Reduction in Perceived Stress Scale score
Description
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.
Time Frame
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks
Title
Reduction in methylation of the GrimAge epigenetic clock
Description
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.
Time Frame
Baseline and 12 weeks
Title
Reduction in transcription of the nuclear factor kappa-B (NF-κB) pathway
Description
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.
Time Frame
Baseline and 12 weeks
Title
Reduction in serum interleukin-6 (IL-6) level
Description
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.
Time Frame
Baseline and 12 weeks
Title
Increase in telomere length of leukocytes
Description
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.
Time Frame
Baseline and 12 weeks
Title
Increase in serum telomerase level
Description
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.
Time Frame
Baseline and 12 weeks
Title
Increase in serum brain-derived neurotropic factor (BDNF) level
Description
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.
Time Frame
Baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sudha Prathikanti, MD
Phone
415-516-3867
Email
sudha.prathikanti@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sudha Prathikanti, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28301561
Citation
Prathikanti S, Rivera R, Cochran A, Tungol JG, Fayazmanesh N, Weinmann E. Treating major depression with yoga: A prospective, randomized, controlled pilot trial. PLoS One. 2017 Mar 16;12(3):e0173869. doi: 10.1371/journal.pone.0173869. eCollection 2017.
Results Reference
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PubMed Identifier
37032928
Citation
Wu Y, Yan D, Yang J. Effectiveness of yoga for major depressive disorder: A systematic review and meta-analysis. Front Psychiatry. 2023 Mar 23;14:1138205. doi: 10.3389/fpsyt.2023.1138205. eCollection 2023.
Results Reference
background
PubMed Identifier
27174729
Citation
Naveen GH, Varambally S, Thirthalli J, Rao M, Christopher R, Gangadhar BN. Serum cortisol and BDNF in patients with major depression-effect of yoga. Int Rev Psychiatry. 2016 Jun;28(3):273-8. doi: 10.1080/09540261.2016.1175419. Epub 2016 May 13.
Results Reference
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PubMed Identifier
26677763
Citation
Deng W, Cheung ST, Tsao SW, Wang XM, Tiwari AF. Telomerase activity and its association with psychological stress, mental disorders, lifestyle factors and interventions: A systematic review. Psychoneuroendocrinology. 2016 Feb;64:150-63. doi: 10.1016/j.psyneuen.2015.11.017. Epub 2015 Nov 25.
Results Reference
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PubMed Identifier
31141465
Citation
Nugent NR, Brick L, Armey MF, Tyrka AR, Ridout KK, Uebelacker LA. Benefits of Yoga on IL-6: Findings from a Randomized Controlled Trial of Yoga for Depression. Behav Med. 2021 Jan-Mar;47(1):21-30. doi: 10.1080/08964289.2019.1604489. Epub 2019 May 29.
Results Reference
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PubMed Identifier
31675136
Citation
Pisanu C, Tsermpini EE, Skokou M, Kordou Z, Gourzis P, Assimakopoulos K, Congiu D, Meloni A, Balasopoulos D, Patrinos GP, Squassina A. Leukocyte telomere length is reduced in patients with major depressive disorder. Drug Dev Res. 2020 May;81(3):268-273. doi: 10.1002/ddr.21612. Epub 2019 Nov 1.
Results Reference
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PubMed Identifier
33820909
Citation
Protsenko E, Yang R, Nier B, Reus V, Hammamieh R, Rampersaud R, Wu GWY, Hough CM, Epel E, Prather AA, Jett M, Gautam A, Mellon SH, Wolkowitz OM. "GrimAge," an epigenetic predictor of mortality, is accelerated in major depressive disorder. Transl Psychiatry. 2021 Apr 6;11(1):193. doi: 10.1038/s41398-021-01302-0.
Results Reference
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PubMed Identifier
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Citation
Tolahunase MR, Sagar R, Faiq M, Dada R. Yoga- and meditation-based lifestyle intervention increases neuroplasticity and reduces severity of major depressive disorder: A randomized controlled trial. Restor Neurol Neurosci. 2018;36(3):423-442. doi: 10.3233/RNN-170810.
Results Reference
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PubMed Identifier
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Citation
Venditti S, Verdone L, Reale A, Vetriani V, Caserta M, Zampieri M. Molecules of Silence: Effects of Meditation on Gene Expression and Epigenetics. Front Psychol. 2020 Aug 11;11:1767. doi: 10.3389/fpsyg.2020.01767. eCollection 2020.
Results Reference
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Treating Major Depression With Yoga Mono-therapy
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