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

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ClinicalTrials.gov Identifier: NCT01210651
Recruitment Status : Completed
First Posted : September 28, 2010
Results First Posted : January 11, 2017
Last Update Posted : January 11, 2017
Sponsor:
Collaborators:
Mental Insight Foundation
Pritzker Family Foundation
Mount Zion Health Fund
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Depression, Unipolar
Interventions Behavioral: Hatha Yoga Practice Group
Behavioral: Attention Control Education Group
Enrollment 38
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Hatha Yoga Practice Group Attention Control Education Group
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 20 [1] 18 [1]
Number Attending 1st Assigned Session 18 12
Completed 15 10
Not Completed 5 8
Reason Not Completed
Lost to Follow-up             1             1
schedule conflicts             1             5
Withdrawn by PI for disruptive behavior             0             1
Withdrawal by Subject             1             1
Injury outside study             2             0
[1]
Number randomized to intervention, but not number who started intervention by attending 1st session.
Arm/Group Title Hatha Yoga Practice Group Attention Control Education Group Total
Hide Arm/Group Description 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 of all reporting groups
Overall Number of Baseline Participants 20 18 38
Hide Baseline Analysis Population Description
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.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 18 participants 38 participants
43.1  (15.2) 43.8  (14.7) 43.4  (14.8)
[1]
Measure Description: Participant provided birthdate at the time of the office screening visit, and age was calculated as of the screening date.
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Years
Number Analyzed 20 participants 18 participants 38 participants
Lowest age among participants 22 23 22
Highest age among participants 64 72 72
[1]
Measure Description: Age range of participants, with ages calculated as of the screening visit date.
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 18 participants 38 participants
Female
15
  75.0%
11
  61.1%
26
  68.4%
Male
5
  25.0%
7
  38.9%
12
  31.6%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 18 participants 38 participants
European descent
13
  65.0%
9
  50.0%
22
  57.9%
Asian descent
2
  10.0%
4
  22.2%
6
  15.8%
Latino descent
2
  10.0%
2
  11.1%
4
  10.5%
African descent
1
   5.0%
2
  11.1%
3
   7.9%
Multi-ethnic descent
2
  10.0%
1
   5.6%
3
   7.9%
[1]
Measure Description: Participant provided self-described ethnic identity at the time of the office screening visit.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 18 participants 38 participants
20 18 38
Married   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 18 participants 38 participants
1
   5.0%
3
  16.7%
4
  10.5%
[1]
Measure Description: Participant provided information on marital status at the time of the office screening visit.
Highest Education   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 18 participants 38 participants
High school diploma
0
   0.0%
2
  11.1%
2
   5.3%
Two years of college
5
  25.0%
7
  38.9%
12
  31.6%
Four-year college degree or higher
15
  75.0%
9
  50.0%
24
  63.2%
[1]
Measure Description: Participant provided information on highest level of education attained at the time of the office screening visit.
Employment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 18 participants 38 participants
Employed
8
  40.0%
12
  66.7%
20
  52.6%
Student
2
  10.0%
2
  11.1%
4
  10.5%
Retired
3
  15.0%
2
  11.1%
5
  13.2%
Unemployed
7
  35.0%
2
  11.1%
9
  23.7%
Prior Yoga Exposure   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 18 participants 38 participants
10
  50.0%
14
  77.8%
24
  63.2%
[1]
Measure Description: Prior yoga exposure was defined as the report during screening of any past participation in any individual or group yoga classes/exercises.
Participants with Prior Depressive Episodes   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 18 participants 38 participants
Participants with 0 prior episodes
3
  15.0%
1
   5.6%
4
  10.5%
Participants with 1 prior episode
12
  60.0%
10
  55.6%
22
  57.9%
Participants with 2 prior episodes
4
  20.0%
5
  27.8%
9
  23.7%
Participants with 3 prior episodes
1
   5.0%
2
  11.1%
3
   7.9%
[1]
Measure Description: 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 Antidepressant Trials   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 18 participants 38 participants
Participants with 0 prior trials
10
  50.0%
3
  16.7%
13
  34.2%
Participants with 1 prior trial
5
  25.0%
10
  55.6%
15
  39.5%
Participants with 2 prior trials
2
  10.0%
3
  16.7%
5
  13.2%
Participants with 3 prior trials
3
  15.0%
1
   5.6%
4
  10.5%
Participants with 4+ prior trials
0
   0.0%
1
   5.6%
1
   2.6%
[1]
Measure Description: 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.
Screening Score on Beck Depression Inventory-II   [1] 
Mean (Standard Deviation)
Unit of measure:  Points on a scale
Number Analyzed 20 participants 18 participants 38 participants
22.8  (4.4) 22.4  (4.6) 22.4  (4.5)
[1]
Measure Description: 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 Folstein Mini Mental Status Exam   [1] 
Mean (Standard Deviation)
Unit of measure:  Points on a scale
Number Analyzed 20 participants 18 participants 38 participants
27.7  (1.8) 28.4  (1.2) 28.0  (1.6)
[1]
Measure Description: 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.
1.Primary Outcome
Title Intent-to-Treat Analysis of Adjusted Mean Beck Depression Inventory-II Scores Over Intervention Period
Hide Description 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.
Time Frame 0 wks, 2 wks, 4 wks, 6 wks, 8 wks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Hatha Yoga Practice Group Attention Control Education Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 20 18
Least Squares Mean (95% Confidence Interval)
Unit of Measure: points on a scale
Adjusted Mean BDI Score at 0 wks
20.98
(18.45 to 23.51)
19.92
(17.26 to 22.58)
Adjusted Mean BDI Score at 2 wks
15.15
(12.17 to 18.12)
13.06
(8.91 to 17.20)
Adjusted Mean BDI Score at 4 wks
14.35
(11.28 to 17.41)
14.66
(10.76 to 18.56)
Adjusted Mean BDI Score at 6 wks
13.04
(9.46 to 16.62)
12.72
(7.82 to 17.62)
Adjusted Mean BDI Score at 8 wks
11.51
(8.69 to 14.33)
16.93
(13.56 to 20.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hatha Yoga Practice Group, Attention Control Education Group
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments Analysis performed via Stata v14.1. Alpha was 2-tailed. P-value was calculated, with p-value < 0.05 required a priori to reject the null hypothesis.
Method Regression, Generalized Least Squares
Comments [Not Specified]
2.Primary Outcome
Title Total Change Scores on Beck Depression Inventory-II Among Study Completers
Hide Description 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.
Time Frame 0 wks and 8 wks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Hatha Yoga Practice Group Attention Control Education Group
Hide Arm/Group Description:
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 attended 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks.
Overall Number of Participants Analyzed 15 10
Mean (Standard Deviation)
Unit of Measure: points on a scale
Mean BDI Score at 0 wks 20.47  (6.00) 18.00  (6.43)
Mean BDI Score at 8 wks 11.00  (10.01) 16.30  (7.63)
Total Change Score on BDI -9.47  (8.85) -1.70  (6.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hatha Yoga Practice Group, Attention Control Education Group
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments Analysis performed via Stata v14.1, with P-value calculated using a t-distribution and assuming unequal variances in the two samples. Alpha was two-tailed. P-value < 0.05 was required a priori to reject the null hypothesis.
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Number of Study Completers With Remitted Depression, Per Completers Analysis of BDI Scores at 8 Weeks
Hide Description 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.
Time Frame 8 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Hatha Yoga Practice Group Attention Control Education Group
Hide Arm/Group Description:
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 educational seminars on yoga history twice a week for a total of 8 weeks.
Overall Number of Participants Analyzed 15 10
Measure Type: Number
Unit of Measure: participants
Number of Study Completers with 8-wk BDI score ≤ 9 9 1
Number of Study Completers with 8-wk BDI score > 9 6 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hatha Yoga Practice Group, Attention Control Education Group
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments Analysis performed via Stata v14.1. Alpha was 2-tailed. P-value was calculated, with a p-value < 0.05 required a priori to reject the null hypothesis.
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Total Change Scores on General Self-Efficacy Scale (GSES) Among Study Completers
Hide Description 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.
Time Frame 0 wks, 8 wks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Hatha Yoga Practice Group Attention Control Education Group
Hide Arm/Group Description:
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 educational seminars on yoga history twice a week for a total of 8 weeks.
Overall Number of Participants Analyzed 15 10
Mean (Standard Deviation)
Unit of Measure: points on a scale
Mean GSES Score at 0 wks 26.87  (3.09) 28.50  (4.33)
Mean GSES Score at 8 wks 29.00  (3.89) 30.00  (2.67)
Total Change Score on GSES 2.13  (2.07) 1.50  (2.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hatha Yoga Practice Group, Attention Control Education Group
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments Analysis performed via Stata v14.1, with P-value calculated using a t-distribution and assuming unequal variances in the two samples. Alpha was two-tailed. P-value < 0.05 was required a priori to reject the null hypothesis.
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Total Change Scores on Rosenberg Self-Esteem Scale (RSES) Among Study Completers
Hide Description 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.
Time Frame 0 wks, 8 wks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Yoga Practice Group Attention Control Group
Hide Arm/Group Description:
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 educational seminars on yoga history twice a week for a total of 8 weeks.
Overall Number of Participants Analyzed 15 10
Mean (Standard Deviation)
Unit of Measure: points on a scale
Mean RSES Score at 0 wks 14.6  (3.48) 16.0  (3.77)
Mean RSES Score at 8 wks 17.47  (3.87) 16.2  (3.88)
Total Change Score on RSES 2.87  (3.42) 0.20  (3.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Yoga Practice Group, Attention Control Group
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
Comments Analysis performed via Stata v14.1, with P-value calculated using a t-distribution and assuming unequal variances in the two samples. Alpha was two-tailed. P-value < 0.05 was required a priori to reject the null hypothesis.
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Adverse event data were collected continuously over the 8 month period from recruitment to completion of all interventions (May 2010 through Jan 2011).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Yoga Practice Group Attention Control Group
Hide Arm/Group Description 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. Participants in this group met for 90-minute education seminars on yoga history and philosophy twice a week for a total of 8 weeks.
All-Cause Mortality
Yoga Practice Group Attention Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Yoga Practice Group Attention Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Yoga Practice Group Attention Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/18 (27.78%)      0/12 (0.00%)    
Musculoskeletal and connective tissue disorders     
Musculoskeletal soreness or discomfort *  5/18 (27.78%)  10 0/12 (0.00%)  0
*
Indicates events were collected by 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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Sudha Prathikanti, MD
Organization: UCSF
Phone: 415-516-3867
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01210651     History of Changes
Other Study ID Numbers: H49362-35940-01
First Submitted: September 21, 2010
First Posted: September 28, 2010
Results First Submitted: June 7, 2016
Results First Posted: January 11, 2017
Last Update Posted: January 11, 2017