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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01210651
Study type Interventional
Source University of California, San Francisco
Contact
Status Completed
Phase N/A
Start date May 2010
Completion date January 2011

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