Treating Depression With Yoga
| Tracking Information | |||||
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| First Received Date ICMJE | September 21, 2010 | ||||
| Last Updated Date | January 31, 2011 | ||||
| Start Date ICMJE | May 2010 | ||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Beck Depression Inventory (BDI-II) [ Time Frame: Baseline, +2 weeks, +4 weeks, +6 weeks, +8 weeks ] [ Designated as safety issue: Yes ] Measure the depression severity of the study participants. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01210651 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treating Depression With Yoga | ||||
| Official Title ICMJE | Treating Depression With Yoga: A Randomized Controlled Pilot Trial With Adults and Adolescents | ||||
| Brief Summary | This study is a single-center, single-blind, randomized, controlled, parallel group, pilot trial involving 40 participants with mild to moderate depression. The main study hypothesis is that compared to depressed participants randomized to the classroom control group, depressed participants randomized to the yoga exercise group will achieve statistically significant reduction in depression severity, as measured by scores on the Beck Depression Inventory (BDI-II). Individuals meeting all eligibility criteria will be randomized equally to one of two intervention groups: an active intervention group assigned to practice yoga exercises, versus a classroom control group assigned to attend a yoga philosophy course. Participants in both interventions groups will meet for 90-minute sessions 2 times per week for 8 weeks total. Upon completion of the assigned study intervention, any participant randomized to the classroom control group will have the option of attending free yoga sessions at UCSF to learn and practice the yoga exercises used in the active intervention. |
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| Detailed Description | The primary outcome measure will be depression severity, as measured by BDI-II scores; the BDI-II will be administered at baseline, and again at 2 weeks, 4 weeks, 6 weeks, and 8 weeks. Secondary outcome measures will be participant self-efficacy and self-esteem, as measured respectively by the General Self-Efficacy Scale (GSES) and the Rosenberg Self-Esteem Scale (RSES; the GSES and the RSES will be administered at baseline and again at 8 weeks. At the end of the study, blinded outcome assessors will evaluate whether participants in the yoga exercise group, in comparison to those in the classroom control group, achieve the following: (a) statistically significant reduction in depression severity, as measured by scores on the BDI-II, and (b) statistically significant increase in self-efficacy and self-esteem, as measured by scores on the GSES and the RSES, respectively. Investigators will also assess demographic and other characteristics of all participants responding to recruitment efforts, and determine recruitment response rates, as well as rates of enrollment, adherence and attrition. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Depression | ||||
| Intervention ICMJE | Behavioral: Yoga Exercise
Yoga exercises performed during 90-minute sessions twice a week for a total of 8 weeks. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Completion Date | January 2011 | ||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 14 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01210651 | ||||
| Other Study ID Numbers ICMJE | H49362-35940-01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Sudha Prathikanti, MD, UCSF Department of Psychiatry | ||||
| Study Sponsor ICMJE | University of California, San Francisco | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of California, San Francisco | ||||
| Verification Date | August 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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