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
  Purpose

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.


Condition Intervention
Depression
Behavioral: Yoga Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Treating Depression With Yoga: A Randomized Controlled Pilot Trial With Adults and Adolescents

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: May 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Yoga Exercise
Yoga exercises performed during 90-minute sessions twice a week for a total of 8 weeks.
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.

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.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01210651

Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Mental Insight Foundation
Pritzker Family Foundation
Mount Zion Health Fund
Investigators
Principal Investigator: Sudha Prathikanti, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Sudha Prathikanti, MD, UCSF Department of Psychiatry
ClinicalTrials.gov Identifier: NCT01210651     History of Changes
Other Study ID Numbers: H49362-35940-01
Study First Received: September 21, 2010
Last Updated: January 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Yoga
Depression
Self-Efficacy
Self-Esteem

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014