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.

Treating Major Depression With Yoga: A Prospective, Randomized Controlled Pilot Trial

Depression, Unipolar

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.

Hatha Yoga Practice Group

Attention Control Education Group

The Beck Depression Inventory-II (BDI) is a 21-item validated instrument for the self-report of depressive symptoms, with individual item scores summed to yield a total possible BDI score that ranges from 0-63. BDI scores from 0-13 suggest absent to minimal depressive symptoms, from 14-19 mild symptoms, from 20-28 moderate symptoms, and from 29-63 severe symptoms. Regression analysis software examined the BDI scores measured in study participants every 2 wks from intervention start at 0 wks until intervention end at 8 wks, using maximum likelihood estimations to derive an adjusted mean BDI score for each intervention group at each measurement point.

The Beck Depression Inventory-II (BDI) is a 21-item validated instrument for the self-report of depressive symptoms, with individual item scores summed to yield a total possible BDI score that ranges from 0-63. BDI scores from 0-13 suggest absent to minimal depressive symptoms, from 14-19 mild symptoms, from 20-28 moderate symptoms, and from 29-63 severe symptoms. BDI scores of study completers were examined, and the total change score on BDI was calculated for each intervention group as the mean BDI score at 0 wks subtracted from the mean BDI score at 8 wks.

The Beck Depression Inventory-II (BDI) is a 21-item validated instrument for the self-report of depressive symptoms, with individual item scores summed to yield a total possible BDI score that ranges from 0-63. BDI scores from 0-13 suggest absent to minimal depressive symptoms, from 14-19 mild symptoms, from 20-28 moderate symptoms, and from 29-63 severe symptoms. Analysis examined BDI scores of study completers and identified in each intervention group the number of participants with an 8-wk BDI score ≤ 9, defined as remitted depression.

The General Self-Efficacy Scale (GSES) is a 10-item, self-administered, validated psychometric instrument to measure self-efficacy, defined as the belief that one's actions are responsible for successful outcomes in coping with difficult life demands. Each item is scored from 1 to 4, with a total GSES score derived by summing the individual item scores. Possible GSES scores range from 10 (no belief in one's self-efficacy) to 40 (strongest belief in one's self-efficacy). GSES scores of study completers were examined, and the total change score on GSES was calculated for each intervention group as the mean GSES score at 0 wks subtracted from the mean GSES score at 8 wks.

The Rosenberg Self-Esteem Scale (RSES) is a 10-item, self-administered, validated psychometric instrument to measure self-esteem, defined as having an overall feeling of self-worth and self-acceptance. Each item is scored from 0 to 3, and individual item scores are summed to yield a total possible RSES ranging from 0-30. RSES scores from 0-14 suggest low self-esteem, from 15-25 normal self-esteem, and from 26-30 high self-esteem. RSES scores of study completers were examined, and the total change score on RSES was calculated for each intervention group as the mean RSES score at 0 wks subtracted from the mean RSES score at 8 wks.

Participants in this group practiced 90-minute sessions of hatha yoga exercises twice weekly for a total of 8 weeks.

Participants in this group attended 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks.

University of California San Francisco

Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks. week for a total of 8 weeks.

Yoga Practice Group

Participants in this group met for 90-minute education seminars on yoga history and philosophy twice a week for a total of 8 weeks.

Attention Control Group

Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.

Participants in this group met for 90-minute education seminars on yoga history twice a week for a total of 8 weeks.

Total

Participant provided birthdate at the time of the office screening visit, and age was calculated as of the screening date.

Age, Continuous

Lowest age among participants

Highest age among participants

Age range of participants, with ages calculated as of the screening visit date.

Age, Customized

Gender

European descent

Asian descent

Latino descent

African descent

Multi-ethnic descent

Participant provided self-described ethnic identity at the time of the office screening visit.

Race/Ethnicity, Customized

United States

Region of Enrollment

Participant provided information on marital status at the time of the office screening visit.

Married

High school diploma

Two years of college

Four-year college degree or higher

Participant provided information on highest level of education attained at the time of the office screening visit.

Highest Education

Employed

Student

Retired

Unemployed

Employment

Prior yoga exposure was defined as the report during screening of any past participation in any individual or group yoga classes/exercises.

Prior Yoga Exposure

Participants with 0 prior episodes

Participants with 1 prior episode

Participants with 2 prior episodes

Participants with 3 prior episodes

During the Mini International Neuro-Psychiatric Interview conducted at screening, participant was asked questions to ascertain the number of any prior discrete mood episodes meeting criteria for unipolar major depression.

Participants with Prior Depressive Episodes

Participants with 0 prior trials

Participants with 1 prior trial

Participants with 2 prior trials

Participants with 3 prior trials

Participants with 4+ prior trials

During the Mini International Neuro-Psychiatric Interview conducted at screening, participant reported on the total number of anti-depressant medication trials, if any, received as treatment during any prior depressive episodes.

Participants with Prior Antidepressant Trials

The Beck Depression Inventory-II (BDI) is a 21-item validated instrument for the self-report of depressive symptoms, with individual item scores summed to yield a total possible BDI score that ranges from 0-63. BDI scores from 0-13 suggest absent to minimal depressive symptoms, from 14-19 mild symptoms, from 20-28 moderate symptoms, and from 29-63 severe symptoms.

Screening Score on Beck Depression Inventory-II

The Folstein Mini Mental Status Exam (MMSE) is a validated, clinician-administered instrument for assessing cognition via tests of orientation, attention, calculation, memory, and both written and spoken language. Scores from each cognitive test are summed to derive a total score ranging from 0 (worst score) to 30 (best score). Cognitive performance as measured by the MMSE varies within the population by age and educational level, but scores below 24 may suggest cognitive impairment.

Screening Score on Folstein Mini Mental Status Exam

Baseline population comprised of all participants randomized to the 2 intervention groups, regardless of whether participants subsequently began intervention by attending the first assigned session at 0 weeks.

Small sample size; not possible to blind participants to intervention; sub-optimal adherence/completion rates, especially in attention control group; however, adherence/completion rates comparable to many exercise-based interventions for depression.

Sudha Prathikanti, MD

A random-effects, generalized least squares (GLS) regression model for depression severity was used to analyze participant BDI scores measured just before 1st assigned session at 0 wks, and just after assigned sessions at 2 wks, 4 wks, 6 wks and 8 wks. BDI Scores were modeled as correlated within participants but independent between participants. The GLS regression model tested the null hypothesis that no significant effects on BDI scores would be found by intervention and intervention-by-time.

Adjusted Mean BDI Score at 0 wks

Adjusted Mean BDI Score at 2 wks

Adjusted Mean BDI Score at 4 wks

Adjusted Mean BDI Score at 6 wks

Adjusted Mean BDI Score at 8 wks

Intent-to-Treat population was comprised of all randomized participants in both intervention groups, regardless of adherence to protocol or premature dropout. BDI scores of any participants missing at 0 wks were imputed by carrying forward their BDI scores from screening.

Intent-to-Treat Analysis of Adjusted Mean Beck Depression Inventory-II Scores Over Intervention Period

Statistical analysis examined Total Change Scores on BDI, using two sample t-test to evaluate the null hypothesis that the Total Change Score on BDI for each intervention group would be statistically comparable.

Mean BDI Score at 0 wks

Mean BDI Score at 8 wks

Total Change Score on BDI

Population of study completers was comprised of participants in both intervention groups who provided study measures at intervention start at 0 wks and at intervention end at 8 wks.

Total Change Scores on Beck Depression Inventory-II Among Study Completers

Fisher's Exact test evaluated null hypothesis that the proportion of study completers with remitted depression would be statistically comparable in the 2 intervention groups.

Number of Study Completers with 8-wk BDI score ≤ 9

Number of Study Completers with 8-wk BDI score > 9

Participants in this group met for 90-minute educational seminars on yoga history twice a week for a total of 8 weeks.

Population of study completers with remitted depression was comprised of participants in both intervention groups who provided study measures at 0 wks and 8 wks, and achieved an 8-wk BDI score ≤ 9.

Number of Study Completers With Remitted Depression, Per Completers Analysis of BDI Scores at 8 Weeks

Statistical analysis examined Total Change Scores on GSES, using an independent samples t-test to evaluate null hypothesis that Total Change Score on GSES for each intervention group would be statistically comparable.

Mean GSES Score at 0 wks

Mean GSES Score at 8 wks

Total Change Score on GSES

Population of study completers was comprised of participants in both intervention groups who provided study measures at intervention start at 0 wks and at intervention finish at 8 wks.

Total Change Scores on General Self-Efficacy Scale (GSES) Among Study Completers

Statistical analysis examined Total Change Scores on RSES, using an independent samples t-test to evaluate null hypothesis that Total Change Score on RSES for each intervention group would be statistically comparable.

Mean RSES Score at 0 wks

Mean RSES Score at 8 wks

Total Change Score on RSES

Total Change Scores on Rosenberg Self-Esteem Scale (RSES) Among Study Completers

Participants in this group met for 90-minute yoga practice sessions twice a weekly for a total of 8 weeks.

Participants in this group met for 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks.

Treating Major Depression With Yoga: A Prospective, Randomized Controlled Pilot Trial

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?