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| Name | Class |
|---|---|
| Mental Insight Foundation | UNKNOWN |
| Pritzker Family Foundation | OTHER |
| Mount Zion Health Fund | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hatha Yoga Practice Group | Experimental | Participants in this group practiced 90-minute sessions of hatha yoga exercises twice weekly for a total of 8 weeks. |
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| Attention Control Education Group | Active Comparator | Participants in this group attended 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hatha Yoga Practice Group | Behavioral | The hatha yoga intervention was a sequence of classical yoga practices, comprised of breathing techniques, mindful body postures, and a final deep relaxation pose. The same sequence was used in all sessions. Yoga practices were broken down into component elements and taught progressively to each student in accordance with his or her ability. Participants were encouraged to remain within their range of motion or comfort. Accommodations were made for those with limitations in tolerance or flexibility for any exercise. Blocks, bolsters and other props were used to support participants in learning and holding yoga poses safely, particularly during back-bends or inverted poses. The intervention was delivered by a licensed, registered nurse, who was also a registered yoga teacher. |
| Measure | Description | Time Frame |
|---|---|---|
| Intent-to-Treat Analysis of Adjusted Mean Beck Depression Inventory-II Scores Over Intervention Period | 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. | 0 wks, 2 wks, 4 wks, 6 wks, 8 wks |
| Total Change Scores on Beck Depression Inventory-II Among Study Completers | 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. | 0 wks and 8 wks |
| Number of Study Completers With Remitted Depression, Per Completers Analysis of BDI Scores at 8 Weeks | 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. | 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total Change Scores on General Self-Efficacy Scale (GSES) Among Study Completers | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sudha Prathikanti, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28301561 | Derived | 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. |
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Individual participant data from this clinical trial have been de-identified of any protected health information, and made available for sharing with other researchers. The dataset includes demographic/clinical variables obtained from all randomized participants at screening, as well as primary and secondary outcome measures obtained from participants in both intervention groups over the course of the 8-week intervention period. The dataset is accessible as an Excel file via the following web link: http://prathikanti.com/studydata/
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Participants were recruited via consecutive sampling of eligible individuals responding to ads approved by the Institutional Review Board of the University of California, San Francisco. Ads were posted in San Francisco libraries, shopping areas, community centers, outpatient clinics, local newspapers, online classifieds & clinical trials websites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hatha Yoga Practice Group | Participants in this group met for 90-minute yoga practice sessions twice a weekly for a total of 8 weeks. |
| FG001 | Attention Control Education Group | Participants in this group met for 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Hatha Yoga Practice Group | Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks. |
| BG001 | Attention Control Education Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participant provided birthdate at the time of the office screening visit, and age was calculated as of the screening date. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intent-to-Treat Analysis of Adjusted Mean Beck Depression Inventory-II Scores Over Intervention Period | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | points on a scale | 0 wks, 2 wks, 4 wks, 6 wks, 8 wks |
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Adverse event data were collected continuously over the 8 month period from recruitment to completion of all interventions (May 2010 through Jan 2011).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Yoga Practice Group | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal soreness or discomfort | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sudha Prathikanti, MD | UCSF | 415-516-3867 | sudha.prathikanti@gmail.com |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Attention Control Education Group | Behavioral | The educational seminars taught to participants covered the history and philosophy of the main branches of yoga. Documentary films were used during the seminars to enhance lectures, and interactive dialogue was encouraged between instructor and participants. Seminars were designed to control for non-specific mood benefits of study participation, such as attention from instructors, peer interaction, time spent away from routine activities, and anticipation/interest related to mastering novel yoga-related information. Since participants would join the attention control group on a rolling basis, seminars were designed to function as stand-alone educational modules, rather than requiring presentation in a specific sequence. The instructor for the seminars was a registered yoga teacher. |
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| 0 wks, 8 wks |
| Total Change Scores on Rosenberg Self-Esteem Scale (RSES) Among Study Completers | 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. | 0 wks, 8 wks |
| Withdrawn by PI for disruptive behavior |
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| Withdrawal by Subject |
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| Injury outside study |
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Participants in this group met for 90-minute education seminars on yoga history twice a week for a total of 8 weeks.
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Age, Customized | Age range of participants, with ages calculated as of the screening visit date. | Number | years |
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| Gender | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Participant provided self-described ethnic identity at the time of the office screening visit. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Married | Participant provided information on marital status at the time of the office screening visit. | Count of Participants | Participants |
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| Highest Education | Participant provided information on highest level of education attained at the time of the office screening visit. | Count of Participants | Participants |
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| Employment | Count of Participants | Participants |
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| Prior Yoga Exposure | Prior yoga exposure was defined as the report during screening of any past participation in any individual or group yoga classes/exercises. | Count of Participants | Participants |
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| Participants with Prior Depressive 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. | Count of Participants | Participants |
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| Participants with Prior Antidepressant 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. | Count of Participants | Participants |
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| Screening Score on Beck Depression Inventory-II | 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. | Mean | Standard Deviation | points on a scale |
|
| Screening Score on Folstein Mini Mental Status Exam | 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. | Mean | Standard Deviation | points on a scale |
|
| Description |
|---|
| OG000 | Hatha Yoga Practice Group | Participants in this group practiced 90-minute sessions of hatha yoga exercises twice weekly for a total of 8 weeks. |
| OG001 | Attention Control Education Group | Participants in this group attended 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks. |
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| Primary | Total Change Scores on Beck Depression Inventory-II Among Study Completers | 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. | 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. | Posted | Mean | Standard Deviation | points on a scale | 0 wks and 8 wks |
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| Primary | Number of Study Completers With Remitted Depression, Per Completers Analysis of BDI Scores at 8 Weeks | 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. | 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. | Posted | Number | participants | 8 Weeks |
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| Secondary | Total Change Scores on General Self-Efficacy Scale (GSES) Among Study Completers | 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. | 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. | Posted | Mean | Standard Deviation | points on a scale | 0 wks, 8 wks |
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| Secondary | Total Change Scores on Rosenberg Self-Esteem Scale (RSES) Among Study Completers | 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. | 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. | Posted | Mean | Standard Deviation | points on a scale | 0 wks, 8 wks |
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| 0 |
| 18 |
| 5 |
| 18 |
| EG001 | Attention Control 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. | 0 | 12 | 0 | 12 |
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| Total Change Score on BDI |
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| Total Change Score on GSES |
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| Total Change Score on RSES |
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