Treating Major Depression With Yoga Mono-therapy

Official title

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

Overview

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

• Behavioral Yoga practice
  90-minute group yoga classes twice weekly for 12 weeks.
• Behavioral Education
  90-minute group education classes twice weekly for 12 weeks to learn holistic healthcare modules.

Primary outcome measures

• Change in Beck Depression Inventory-II score [Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks]

Secondary outcome measures (6)

• Change in Perceived Stress Scale score [Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks]
• Change in methylation of the GrimAge epigenetic clock [Time frame: Baseline and 12 weeks]
• Change in transcription of the nuclear factor kappa-B (NF-κB) pathway [Time frame: Baseline and 12 weeks]
• Change in plasma interleukin-6 (IL-6) level [Time frame: Baseline and 12 weeks]
• Change in telomere length of leukocytes [Time frame: Baseline and 12 weeks]
• Change in plasma brain-derived neurotropic factor (BDNF) level [Time frame: Baseline and 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Zuckerberg San Francisco General Hospital — San Francisco

Publications

• 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. PMID 28301561
• 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. PMID 37032928
• 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. PMID 27174729
• 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. PMID 26677763
• 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. PMID 31141465
• 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. PMID 31675136
• 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. PMID 33820909
• 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. PMID 29614706

Identifiers

NCT: NCT06091527 · 23-38755

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗