Treating Depression With Yoga

This study has been completed.
Sponsor:
Collaborators:
Mental Insight Foundation
Pritzker Family Foundation
Mount Zion Health Fund
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01210651
First received: September 21, 2010
Last updated: January 31, 2011
Last verified: August 2010

September 21, 2010
January 31, 2011
May 2010
January 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01210651 on ClinicalTrials.gov Archive Site
  • General Self-Efficacy Scale (GSES) [ Time Frame: Baseline and +8 weeks ] [ Designated as safety issue: No ]
    Measure the participants self-efficacy before and after the intervention.
  • Rosenberg Self-Esteem Scale (RSES) [ Time Frame: Baseline and +8 weeks ] [ Designated as safety issue: No ]
    Measure participants self-esteem before and after the study intervention.
Same as current
Not Provided
Not Provided
 
Treating Depression With Yoga
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Depression
Behavioral: Yoga Exercise
Yoga exercises performed during 90-minute sessions twice a week for a total of 8 weeks.
  • Experimental: Yoga Exercise Group
    Participants in this group will meet for 90-minute sessions of yoga exercises twice a week for a total of 8 weeks. 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 by the General Self-Efficacy Scale (GSES) and the Rosenberg Self-Esteem Scale (RSES), respectively; the GSES and the RSES will be administered at baseline and again at 8 weeks.
    Intervention: Behavioral: Yoga Exercise
  • No Intervention: Control Group
    Participants in this group will meet for 90-minute sessions learning yoga philosophy twice a week for a total of 8 weeks. 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 by the General Self-Efficacy Scale (GSES) and the Rosenberg Self-Esteem Scale (RSES), respectively; the GSES and the RSES will be administered at baseline and again at 8 weeks.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Individuals 14 years of age and older
  • English proficiency sufficient for study participation
  • Depressive symptoms of mild to moderate severity

Exclusion Criteria:

  • Cognitive Impairment
  • Use of antidepressant medication within the 2 months prior to screening, or during study period
  • Use of psychotherapy during study period
  • Use of any yoga, other than study intervention, during study period
  • Diagnosis of bipolar disorder or Axis I anxiety disorders per screening psychiatric interview
  • Diagnosis of substance use disorders within prior 3 months per screening psychiatric
  • Severe major depression, as per screening BDI-II score > 28
  • Current suicidal ideation or past suicide attempts
Both
14 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01210651
H49362-35940-01
No
Sudha Prathikanti, MD, UCSF Department of Psychiatry
University of California, San Francisco
  • Mental Insight Foundation
  • Pritzker Family Foundation
  • Mount Zion Health Fund
Principal Investigator: Sudha Prathikanti, MD University of California, San Francisco
University of California, San Francisco
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP