Depression Clinical Trial
Official title:
Treating Depression With Yoga: A Randomized Controlled Pilot Trial With Adults and Adolescents
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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