Trial Outcomes & Findings for Treating Major Depression With Yoga: A Prospective, Randomized Controlled Pilot Trial (NCT NCT01210651)
NCT ID: NCT01210651
Last Updated: 2017-01-11
Results Overview
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.
COMPLETED
NA
38 participants
0 wks, 2 wks, 4 wks, 6 wks, 8 wks
2017-01-11
Participant Flow
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.
Participant milestones
| Measure |
Hatha Yoga Practice Group
Participants in this group met for 90-minute yoga practice sessions twice a weekly for a total of 8 weeks.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
18
|
|
Overall Study
Number Attending 1st Assigned Session
|
18
|
12
|
|
Overall Study
COMPLETED
|
15
|
10
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
| Measure |
Hatha Yoga Practice Group
Participants in this group met for 90-minute yoga practice sessions twice a weekly for a total of 8 weeks.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
schedule conflicts
|
1
|
5
|
|
Overall Study
Withdrawn by PI for disruptive behavior
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Injury outside study
|
2
|
0
|
Baseline Characteristics
Treating Major Depression With Yoga: A Prospective, Randomized Controlled Pilot Trial
Baseline characteristics by cohort
| Measure |
Hatha Yoga Practice Group
n=20 Participants
Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
|
Attention Control Education Group
n=18 Participants
Participants in this group met for 90-minute education seminars on yoga history twice a week for a total of 8 weeks.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.1 years
STANDARD_DEVIATION 15.2 • n=99 Participants
|
43.8 years
STANDARD_DEVIATION 14.7 • n=107 Participants
|
43.4 years
STANDARD_DEVIATION 14.8 • n=206 Participants
|
|
Age, Customized
Lowest age among participants
|
22 years
n=99 Participants
|
23 years
n=107 Participants
|
22 years
n=206 Participants
|
|
Age, Customized
Highest age among participants
|
64 years
n=99 Participants
|
72 years
n=107 Participants
|
72 years
n=206 Participants
|
|
Gender
Female
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Gender
Male
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
European descent
|
13 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian descent
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Latino descent
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African descent
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multi-ethnic descent
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
18 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Married
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Highest Education
High school diploma
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Highest Education
Two years of college
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Highest Education
Four-year college degree or higher
|
15 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Employment
Employed
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Employment
Student
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Employment
Retired
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Employment
Unemployed
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Prior Yoga Exposure
|
10 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Participants with Prior Depressive Episodes
Participants with 0 prior episodes
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Participants with Prior Depressive Episodes
Participants with 1 prior episode
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Participants with Prior Depressive Episodes
Participants with 2 prior episodes
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Participants with Prior Depressive Episodes
Participants with 3 prior episodes
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Participants with Prior Antidepressant Trials
Participants with 0 prior trials
|
10 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Participants with Prior Antidepressant Trials
Participants with 1 prior trial
|
5 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Participants with Prior Antidepressant Trials
Participants with 2 prior trials
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Participants with Prior Antidepressant Trials
Participants with 3 prior trials
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Participants with Prior Antidepressant Trials
Participants with 4+ prior trials
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Screening Score on Beck Depression Inventory-II
|
22.8 points on a scale
STANDARD_DEVIATION 4.4 • n=99 Participants
|
22.4 points on a scale
STANDARD_DEVIATION 4.6 • n=107 Participants
|
22.4 points on a scale
STANDARD_DEVIATION 4.5 • n=206 Participants
|
|
Screening Score on Folstein Mini Mental Status Exam
|
27.7 points on a scale
STANDARD_DEVIATION 1.8 • n=99 Participants
|
28.4 points on a scale
STANDARD_DEVIATION 1.2 • n=107 Participants
|
28.0 points on a scale
STANDARD_DEVIATION 1.6 • n=206 Participants
|
PRIMARY outcome
Timeframe: 0 wks, 2 wks, 4 wks, 6 wks, 8 wksPopulation: 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.
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.
Outcome measures
| Measure |
Hatha Yoga Practice Group
n=20 Participants
Participants in this group practiced 90-minute sessions of hatha yoga exercises twice weekly for a total of 8 weeks.
|
Attention Control Education Group
n=18 Participants
Participants in this group attended 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks.
|
|---|---|---|
|
Intent-to-Treat Analysis of Adjusted Mean Beck Depression Inventory-II Scores Over Intervention Period
Adjusted Mean BDI Score at 0 wks
|
20.98 points on a scale
Interval 18.45 to 23.51
|
19.92 points on a scale
Interval 17.26 to 22.58
|
|
Intent-to-Treat Analysis of Adjusted Mean Beck Depression Inventory-II Scores Over Intervention Period
Adjusted Mean BDI Score at 2 wks
|
15.15 points on a scale
Interval 12.17 to 18.12
|
13.06 points on a scale
Interval 8.91 to 17.2
|
|
Intent-to-Treat Analysis of Adjusted Mean Beck Depression Inventory-II Scores Over Intervention Period
Adjusted Mean BDI Score at 4 wks
|
14.35 points on a scale
Interval 11.28 to 17.41
|
14.66 points on a scale
Interval 10.76 to 18.56
|
|
Intent-to-Treat Analysis of Adjusted Mean Beck Depression Inventory-II Scores Over Intervention Period
Adjusted Mean BDI Score at 6 wks
|
13.04 points on a scale
Interval 9.46 to 16.62
|
12.72 points on a scale
Interval 7.82 to 17.62
|
|
Intent-to-Treat Analysis of Adjusted Mean Beck Depression Inventory-II Scores Over Intervention Period
Adjusted Mean BDI Score at 8 wks
|
11.51 points on a scale
Interval 8.69 to 14.33
|
16.93 points on a scale
Interval 13.56 to 20.3
|
PRIMARY outcome
Timeframe: 0 wks and 8 wksPopulation: 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.
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.
Outcome measures
| Measure |
Hatha Yoga Practice Group
n=15 Participants
Participants in this group practiced 90-minute sessions of hatha yoga exercises twice weekly for a total of 8 weeks.
|
Attention Control Education Group
n=10 Participants
Participants in this group attended 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks.
|
|---|---|---|
|
Total Change Scores on Beck Depression Inventory-II Among Study Completers
Mean BDI Score at 0 wks
|
20.47 points on a scale
Standard Deviation 6.00
|
18.00 points on a scale
Standard Deviation 6.43
|
|
Total Change Scores on Beck Depression Inventory-II Among Study Completers
Mean BDI Score at 8 wks
|
11.00 points on a scale
Standard Deviation 10.01
|
16.30 points on a scale
Standard Deviation 7.63
|
|
Total Change Scores on Beck Depression Inventory-II Among Study Completers
Total Change Score on BDI
|
-9.47 points on a scale
Standard Deviation 8.85
|
-1.70 points on a scale
Standard Deviation 6.67
|
PRIMARY outcome
Timeframe: 8 WeeksPopulation: 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.
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.
Outcome measures
| Measure |
Hatha Yoga Practice Group
n=15 Participants
Participants in this group practiced 90-minute sessions of hatha yoga exercises twice weekly for a total of 8 weeks.
|
Attention Control Education Group
n=10 Participants
Participants in this group attended 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks.
|
|---|---|---|
|
Number of Study Completers With Remitted Depression, Per Completers Analysis of BDI Scores at 8 Weeks
Number of Study Completers with 8-wk BDI score ≤ 9
|
9 participants
|
1 participants
|
|
Number of Study Completers With Remitted Depression, Per Completers Analysis of BDI Scores at 8 Weeks
Number of Study Completers with 8-wk BDI score > 9
|
6 participants
|
9 participants
|
SECONDARY outcome
Timeframe: 0 wks, 8 wksPopulation: 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.
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.
Outcome measures
| Measure |
Hatha Yoga Practice Group
n=15 Participants
Participants in this group practiced 90-minute sessions of hatha yoga exercises twice weekly for a total of 8 weeks.
|
Attention Control Education Group
n=10 Participants
Participants in this group attended 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks.
|
|---|---|---|
|
Total Change Scores on General Self-Efficacy Scale (GSES) Among Study Completers
Mean GSES Score at 0 wks
|
26.87 points on a scale
Standard Deviation 3.09
|
28.50 points on a scale
Standard Deviation 4.33
|
|
Total Change Scores on General Self-Efficacy Scale (GSES) Among Study Completers
Mean GSES Score at 8 wks
|
29.00 points on a scale
Standard Deviation 3.89
|
30.00 points on a scale
Standard Deviation 2.67
|
|
Total Change Scores on General Self-Efficacy Scale (GSES) Among Study Completers
Total Change Score on GSES
|
2.13 points on a scale
Standard Deviation 2.07
|
1.50 points on a scale
Standard Deviation 2.37
|
SECONDARY outcome
Timeframe: 0 wks, 8 wksPopulation: 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.
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.
Outcome measures
| Measure |
Hatha Yoga Practice Group
n=15 Participants
Participants in this group practiced 90-minute sessions of hatha yoga exercises twice weekly for a total of 8 weeks.
|
Attention Control Education Group
n=10 Participants
Participants in this group attended 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks.
|
|---|---|---|
|
Total Change Scores on Rosenberg Self-Esteem Scale (RSES) Among Study Completers
Mean RSES Score at 0 wks
|
14.6 points on a scale
Standard Deviation 3.48
|
16.0 points on a scale
Standard Deviation 3.77
|
|
Total Change Scores on Rosenberg Self-Esteem Scale (RSES) Among Study Completers
Mean RSES Score at 8 wks
|
17.47 points on a scale
Standard Deviation 3.87
|
16.2 points on a scale
Standard Deviation 3.88
|
|
Total Change Scores on Rosenberg Self-Esteem Scale (RSES) Among Study Completers
Total Change Score on RSES
|
2.87 points on a scale
Standard Deviation 3.42
|
0.20 points on a scale
Standard Deviation 3.01
|
Adverse Events
Yoga Practice Group
Attention Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Yoga Practice Group
n=18 participants at risk
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.
|
Attention Control Group
n=12 participants at risk
Participants in this group met for 90-minute education seminars on yoga history and philosophy twice a week for a total of 8 weeks.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal soreness or discomfort
|
27.8%
5/18 • Number of events 10 • Adverse event data were collected continuously over the 8 month period from recruitment to completion of all interventions (May 2010 through Jan 2011).
|
0.00%
0/12 • Adverse event data were collected continuously over the 8 month period from recruitment to completion of all interventions (May 2010 through Jan 2011).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place