Treating Depression With Yoga

Depression Clinical Trial

Official title:

Treating Depression With Yoga: A Randomized Controlled Pilot Trial With Adults and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01210651
• Other study ID #: H49362-35940-01
• Status: Completed
• Phase: N/A
• First received: September 21, 2010
• Last updated: January 31, 2011
• Start date: May 2010
• Est. completion date: January 2011

Study information

• Verified date: August 2010
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Yoga Exercise
Yoga exercises performed during 90-minute sessions twice a week for a total of 8 weeks.

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Mental Insight Foundation, Mount Zion Health Fund, Pritzker Family Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory (BDI-II)	Measure the depression severity of the study participants.	Baseline, +2 weeks, +4 weeks, +6 weeks, +8 weeks	Yes
Secondary	General Self-Efficacy Scale (GSES)	Measure the participants self-efficacy before and after the intervention.	Baseline and +8 weeks	No
Secondary	Rosenberg Self-Esteem Scale (RSES)	Measure participants self-esteem before and after the study intervention.	Baseline and +8 weeks	No