Clinical trial NCT01210651: Treating Major Depression With Yoga: A Prospective, Randomized Controlled Pilot Trial
Official title: Treating Major Depression With Yoga: A Prospective, Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Unipolar
Keywords: Yoga
Major Depression
Self-Efficacy
Self-Esteem
Hatha yoga
mind-body therapies
depression
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Mental Insight Foundation
name: Pritzker Family Foundation
name: Mount Zion Health Fund
First posted: 2010-09-28
Enrollment: 38
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a randomized controlled pilot trial to evaluate clinical efficacy and feasibility of hatha yoga as a mono-therapy for major depression. Investigators recruited 38 adults in San Francisco meeting criteria for major depression of mild-to-moderate severity, per structured psychiatric interview and scores of 14-28 on Beck Depression Inventory-II (BDI). At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal/nutraceutical mood therapies, or mind-body practices were excluded. Twenty participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8 weeks. Eighteen participants were randomized to 90-minute attention control education groups twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a university clinic. Primary outcome was depression severity, measured by BDI scores every 2 weeks from intervention start at 0 weeks until finish at 8 weeks. Secondary outcomes were self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES) and Rosenberg Self-Esteem Scale (RSES) at 0 weeks and 8 weeks. Blinded assessors analyzed whether change in outcome measures would be statistically comparable between the two intervention groups.

Detailed description: This was a prospective, single-center, single-blind, randomized, controlled, parallel group, pilot trial of an 8-week hatha yoga program as mono-therapy in major depression. Recruitment occurred from May to October 2010, and the trial was concluded in January 2011.

We recruited 38 adults from the San Francisco community who met criteria for major depression of mild-to-moderate severity, as per screening diagnostic evaluation with the Mini International Neuropsychiatric Interview (MINI) and scores of 14 through 28 on the Beck Depression Inventory-II (BDI). At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal/nutraceutical mood remedies, or any mind-body practices were excluded.

Eligible participants were randomized in a 1:1 ratio to one of two instructor-led intervention groups: a hatha yoga practice group assigned to 90-minute hatha yoga practice sessions twice weekly for 8 weeks, versus an attention control education group assigned to 90-minute yoga history seminars twice weekly for 8 weeks. Participants in the hatha yoga group learned and practiced a specific sequence of classical yoga breathing techniques, mindful body postures, and a final deep relaxation pose. The attention control education group explored the history and philosophy of the main branches of yoga through seminars featuring lectures, documentary films, and interactive dialogue between instructor and participants; the seminars were designed to control for non-specific mood benefits of the hatha yoga intervention, such as attention from study personnel, peer interaction, time spent away from routine activities, and anticipation/interest related to mastering novel yoga-related information.

Stratified block randomization was undertaken to ensure that each intervention group had equal numbers of participants with mild depression (per screening BDI scores of 14 to 19) versus moderate depression (per screening BDI scores of 20 to 28).

Participants were informed at screening that anyone randomized to the education group would be offered 16 free hatha yoga classes, upon completion of the study, to learn and practice the same exercises taught to the hatha yoga practice group.

The primary outcome was depression severity, measured by BDI scores at 2-week intervals from intervention start at 0 weeks until intervention end at 8 weeks. Secondary outcomes were self-efficacy and self-esteem, measured respectively by scores on the General Self-Efficacy Scale (GSES) and the Rosenberg Self-Esteem Scale (RSES) at 0 weeks and at 8 weeks. Blinded assessors analyzed outcome data from both intervention groups, testing whether change in outcome measures would be statistically comparable between the two groups.

Eligibility criteria: Inclusion Criteria:

* Individuals 14 years of age and older
* English proficiency sufficient for study participation
* Diagnosis of Axis I unipolar major depression, per screening Mini International Neuro-Psychiatric Interview (MINI)
* Depressive symptoms of mild to moderate intensity, per score of 14-28 on screening Beck Depression Inventory-II (BDI)
* Able to attend all required study sessions

Exclusion Criteria:

* Cognitive Impairment, as per Folstein Mini-mental Status Exam Score \< 24
* Use of any antidepressant medication or herbal/nutraceutical mood therapy within the 2 months prior to screening, or during study period
* Use of psychotherapy during study period
* Use of any yoga or other mind-body practices during study period, other than study intervention
* Per screening MINI, diagnosis of any Axis I disorder other than unipolar major depression, such as bipolar disorder, dysthymia or anxiety disorders
* Per screening MINI, diagnosis of substance use disorders within prior 3 months
* Per screening MINI, current suicidal ideation or past suicide attempts
* Severe depressive symptoms, as per screening BDI score \> 28

Primary outcomes:
measure: Intent-to-Treat Analysis of Adjusted Mean Beck Depression Inventory-II Scores Over Intervention Period
timeFrame: 0 wks, 2 wks, 4 wks, 6 wks, 8 wks
measure: Total Change Scores on Beck Depression Inventory-II Among Study Completers
timeFrame: 0 wks and 8 wks
measure: Number of Study Completers With Remitted Depression, Per Completers Analysis of BDI Scores at 8 Weeks
timeFrame: 8 Weeks
Secondary outcomes:
measure: Total Change Scores on General Self-Efficacy Scale (GSES) Among Study Completers
timeFrame: 0 wks, 8 wks
measure: Total Change Scores on Rosenberg Self-Esteem Scale (RSES) Among Study Completers
timeFrame: 0 wks, 8 wks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sudha Prathikanti, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.