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

This study has been completed.
Sponsor:
Collaborators:
Mental Insight Foundation
Pritzker Family Foundation
Mount Zion Health Fund
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01210651
First received: September 21, 2010
Last updated: November 14, 2016
Last verified: November 2016
Results First Received: June 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depression, Unipolar
Interventions: Behavioral: Hatha Yoga Practice Group
Behavioral: Attention Control Education Group

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Hatha Yoga Practice Group   Attention Control Education Group
STARTED   20 [1]   18 [1] 
Number Attending 1st Assigned Session   18   12 
COMPLETED   15   10 
NOT COMPLETED   5   8 
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Withdrawn by PI for disruptive behavior                0                1 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.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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.
Attention Control Education Group Participants in this group met for 90-minute education seminars on yoga history twice a week for a total of 8 weeks.
Total Total of all reporting groups

Baseline Measures
   Hatha Yoga Practice Group   Attention Control Education Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   18   38 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 43.1  (15.2)   43.8  (14.7)   43.4  (14.8) 
[1] Participant provided birthdate at the time of the office screening visit, and age was calculated as of the screening date.
Age, Customized [1] 
[Units: Years]
     
Lowest age among participants   22   23   22 
Highest age among participants   64   72   72 
[1] Age range of participants, with ages calculated as of the screening visit date.
Gender 
[Units: Participants]
Count of 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] 
[Units: Participants]
Count of Participants
     
European descent   13   9   22 
Asian descent   2   4   6 
Latino descent   2   2   4 
African descent   1   2   3 
Multi-ethnic descent   2   1   3 
[1] Participant provided self-described ethnic identity at the time of the office screening visit.
Region of Enrollment 
[Units: Participants]
     
United States   20   18   38 
Married [1] 
[Units: Participants]
Count of Participants
 1   3   4 
[1] Participant provided information on marital status at the time of the office screening visit.
Highest Education [1] 
[Units: Participants]
Count of Participants
     
High school diploma   0   2   2 
Two years of college   5   7   12 
Four-year college degree or higher   15   9   24 
[1] Participant provided information on highest level of education attained at the time of the office screening visit.
Employment 
[Units: Participants]
Count of Participants
     
Employed   8   12   20 
Student   2   2   4 
Retired   3   2   5 
Unemployed   7   2   9 
Prior Yoga Exposure [1] 
[Units: Participants]
Count of Participants
 10   14   24 
[1] 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] 
[Units: Participants]
Count of Participants
     
Participants with 0 prior episodes   3   1   4 
Participants with 1 prior episode   12   10   22 
Participants with 2 prior episodes   4   5   9 
Participants with 3 prior episodes   1   2   3 
[1] 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] 
[Units: Participants]
Count of Participants
     
Participants with 0 prior trials   10   3   13 
Participants with 1 prior trial   5   10   15 
Participants with 2 prior trials   2   3   5 
Participants with 3 prior trials   3   1   4 
Participants with 4+ prior trials   0   1   1 
[1] 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] 
[Units: Points on a scale]
Mean (Standard Deviation)
 22.8  (4.4)   22.4  (4.6)   22.4  (4.5) 
[1] 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] 
[Units: Points on a scale]
Mean (Standard Deviation)
 27.7  (1.8)   28.4  (1.2)   28.0  (1.6) 
[1] 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.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Intent-to-Treat Analysis of Adjusted Mean Beck Depression Inventory-II Scores Over Intervention Period   [ Time Frame: 0 wks, 2 wks, 4 wks, 6 wks, 8 wks ]

2.  Primary:   Total Change Scores on Beck Depression Inventory-II Among Study Completers   [ Time Frame: 0 wks and 8 wks ]

3.  Primary:   Number of Study Completers With Remitted Depression, Per Completers Analysis of BDI Scores at 8 Weeks   [ Time Frame: 8 Weeks ]

4.  Secondary:   Total Change Scores on General Self-Efficacy Scale (GSES) Among Study Completers   [ Time Frame: 0 wks, 8 wks ]

5.  Secondary:   Total Change Scores on Rosenberg Self-Esteem Scale (RSES) Among Study Completers   [ Time Frame: 0 wks, 8 wks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: sudha.prathikanti@gmail.com



Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01210651     History of Changes
Other Study ID Numbers: H49362-35940-01
Study First Received: September 21, 2010
Results First Received: June 7, 2016
Last Updated: November 14, 2016