Try our beta test site

Treating Major Depression With Yoga: A Prospective, Randomized Controlled Pilot Trial

This study has been completed.
Sponsor:
Collaborators:
Mental Insight Foundation
Pritzker Family Foundation
Mount Zion Health Fund
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01210651
First received: September 21, 2010
Last updated: November 14, 2016
Last verified: November 2016
  Purpose
This was a randomized controlled pilot trial to evaluate clinical efficacy and feasibility of hatha yoga as a mono-therapy for major depression. Investigators recruited 38 adults in San Francisco meeting criteria for major depression of mild-to-moderate severity, per structured psychiatric interview and scores of 14-28 on Beck Depression Inventory-II (BDI). At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal/nutraceutical mood therapies, or mind-body practices were excluded. Twenty participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8 weeks. Eighteen participants were randomized to 90-minute attention control education groups twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a university clinic. Primary outcome was depression severity, measured by BDI scores every 2 weeks from intervention start at 0 weeks until finish at 8 weeks. Secondary outcomes were self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES) and Rosenberg Self-Esteem Scale (RSES) at 0 weeks and 8 weeks. Blinded assessors analyzed whether change in outcome measures would be statistically comparable between the two intervention groups.

Condition Intervention
Depression, Unipolar
Behavioral: Hatha Yoga Practice Group
Behavioral: Attention Control Education Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Major Depression With Yoga: A Prospective, Randomized Controlled Pilot Trial

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

Primary Outcome Measures:
  • Intent-to-Treat Analysis of Adjusted Mean Beck Depression Inventory-II Scores Over Intervention Period [ Time Frame: 0 wks, 2 wks, 4 wks, 6 wks, 8 wks ]
    The Beck Depression Inventory-II (BDI) is a 21-item validated instrument for the self-report of depressive symptoms, with individual item scores summed to yield a total possible BDI score that ranges from 0-63. BDI scores from 0-13 suggest absent to minimal depressive symptoms, from 14-19 mild symptoms, from 20-28 moderate symptoms, and from 29-63 severe symptoms. Regression analysis software examined the BDI scores measured in study participants every 2 wks from intervention start at 0 wks until intervention end at 8 wks, using maximum likelihood estimations to derive an adjusted mean BDI score for each intervention group at each measurement point.

  • Total Change Scores on Beck Depression Inventory-II Among Study Completers [ Time Frame: 0 wks and 8 wks ]
    The Beck Depression Inventory-II (BDI) is a 21-item validated instrument for the self-report of depressive symptoms, with individual item scores summed to yield a total possible BDI score that ranges from 0-63. BDI scores from 0-13 suggest absent to minimal depressive symptoms, from 14-19 mild symptoms, from 20-28 moderate symptoms, and from 29-63 severe symptoms. BDI scores of study completers were examined, and the total change score on BDI was calculated for each intervention group as the mean BDI score at 0 wks subtracted from the mean BDI score at 8 wks.

  • Number of Study Completers With Remitted Depression, Per Completers Analysis of BDI Scores at 8 Weeks [ Time Frame: 8 Weeks ]
    The Beck Depression Inventory-II (BDI) is a 21-item validated instrument for the self-report of depressive symptoms, with individual item scores summed to yield a total possible BDI score that ranges from 0-63. BDI scores from 0-13 suggest absent to minimal depressive symptoms, from 14-19 mild symptoms, from 20-28 moderate symptoms, and from 29-63 severe symptoms. Analysis examined BDI scores of study completers and identified in each intervention group the number of participants with an 8-wk BDI score ≤ 9, defined as remitted depression.


Secondary Outcome Measures:
  • Total Change Scores on General Self-Efficacy Scale (GSES) Among Study Completers [ Time Frame: 0 wks, 8 wks ]
    The General Self-Efficacy Scale (GSES) is a 10-item, self-administered, validated psychometric instrument to measure self-efficacy, defined as the belief that one's actions are responsible for successful outcomes in coping with difficult life demands. Each item is scored from 1 to 4, with a total GSES score derived by summing the individual item scores. Possible GSES scores range from 10 (no belief in one's self-efficacy) to 40 (strongest belief in one's self-efficacy). GSES scores of study completers were examined, and the total change score on GSES was calculated for each intervention group as the mean GSES score at 0 wks subtracted from the mean GSES score at 8 wks.

  • Total Change Scores on Rosenberg Self-Esteem Scale (RSES) Among Study Completers [ Time Frame: 0 wks, 8 wks ]
    The Rosenberg Self-Esteem Scale (RSES) is a 10-item, self-administered, validated psychometric instrument to measure self-esteem, defined as having an overall feeling of self-worth and self-acceptance. Each item is scored from 0 to 3, and individual item scores are summed to yield a total possible RSES ranging from 0-30. RSES scores from 0-14 suggest low self-esteem, from 15-25 normal self-esteem, and from 26-30 high self-esteem. RSES scores of study completers were examined, and the total change score on RSES was calculated for each intervention group as the mean RSES score at 0 wks subtracted from the mean RSES score at 8 wks.


Enrollment: 38
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: Hatha Yoga Practice Group
Participants in this group practiced 90-minute sessions of hatha yoga exercises twice weekly for a total of 8 weeks.
Behavioral: Hatha Yoga Practice Group
The hatha yoga intervention was a sequence of classical yoga practices, comprised of breathing techniques, mindful body postures, and a final deep relaxation pose. The same sequence was used in all sessions. Yoga practices were broken down into component elements and taught progressively to each student in accordance with his or her ability. Participants were encouraged to remain within their range of motion or comfort. Accommodations were made for those with limitations in tolerance or flexibility for any exercise. Blocks, bolsters and other props were used to support participants in learning and holding yoga poses safely, particularly during back-bends or inverted poses. The intervention was delivered by a licensed, registered nurse, who was also a registered yoga teacher.
Other Name: Yoga Practice Group, Hatha Yoga Group, Yoga Exercise Group
Active Comparator: Attention Control Education Group
Participants in this group attended 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks.
Behavioral: Attention Control Education Group
The educational seminars taught to participants covered the history and philosophy of the main branches of yoga. Documentary films were used during the seminars to enhance lectures, and interactive dialogue was encouraged between instructor and participants. Seminars were designed to control for non-specific mood benefits of study participation, such as attention from instructors, peer interaction, time spent away from routine activities, and anticipation/interest related to mastering novel yoga-related information. Since participants would join the attention control group on a rolling basis, seminars were designed to function as stand-alone educational modules, rather than requiring presentation in a specific sequence. The instructor for the seminars was a registered yoga teacher.
Other Name: Attention Control Group, Education Group, Yoga History Group

Detailed Description:

This was a prospective, single-center, single-blind, randomized, controlled, parallel group, pilot trial of an 8-week hatha yoga program as mono-therapy in major depression. Recruitment occurred from May to October 2010, and the trial was concluded in January 2011.

We recruited 38 adults from the San Francisco community who met criteria for major depression of mild-to-moderate severity, as per screening diagnostic evaluation with the Mini International Neuropsychiatric Interview (MINI) and scores of 14 through 28 on the Beck Depression Inventory-II (BDI). At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal/nutraceutical mood remedies, or any mind-body practices were excluded.

Eligible participants were randomized in a 1:1 ratio to one of two instructor-led intervention groups: a hatha yoga practice group assigned to 90-minute hatha yoga practice sessions twice weekly for 8 weeks, versus an attention control education group assigned to 90-minute yoga history seminars twice weekly for 8 weeks. Participants in the hatha yoga group learned and practiced a specific sequence of classical yoga breathing techniques, mindful body postures, and a final deep relaxation pose. The attention control education group explored the history and philosophy of the main branches of yoga through seminars featuring lectures, documentary films, and interactive dialogue between instructor and participants; the seminars were designed to control for non-specific mood benefits of the hatha yoga intervention, such as attention from study personnel, peer interaction, time spent away from routine activities, and anticipation/interest related to mastering novel yoga-related information.

Stratified block randomization was undertaken to ensure that each intervention group had equal numbers of participants with mild depression (per screening BDI scores of 14 to 19) versus moderate depression (per screening BDI scores of 20 to 28).

Participants were informed at screening that anyone randomized to the education group would be offered 16 free hatha yoga classes, upon completion of the study, to learn and practice the same exercises taught to the hatha yoga practice group.

The primary outcome was depression severity, measured by BDI scores at 2-week intervals from intervention start at 0 weeks until intervention end at 8 weeks. Secondary outcomes were self-efficacy and self-esteem, measured respectively by scores on the General Self-Efficacy Scale (GSES) and the Rosenberg Self-Esteem Scale (RSES) at 0 weeks and at 8 weeks. Blinded assessors analyzed outcome data from both intervention groups, testing whether change in outcome measures would be statistically comparable between the two groups.

  Eligibility

Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals 14 years of age and older
  • English proficiency sufficient for study participation
  • Diagnosis of Axis I unipolar major depression, per screening Mini International Neuro-Psychiatric Interview (MINI)
  • Depressive symptoms of mild to moderate intensity, per score of 14-28 on screening Beck Depression Inventory-II (BDI)
  • Able to attend all required study sessions

Exclusion Criteria:

  • Cognitive Impairment, as per Folstein Mini-mental Status Exam Score < 24
  • Use of any antidepressant medication or herbal/nutraceutical mood therapy within the 2 months prior to screening, or during study period
  • Use of psychotherapy during study period
  • Use of any yoga or other mind-body practices during study period, other than study intervention
  • Per screening MINI, diagnosis of any Axis I disorder other than unipolar major depression, such as bipolar disorder, dysthymia or anxiety disorders
  • Per screening MINI, diagnosis of substance use disorders within prior 3 months
  • Per screening MINI, current suicidal ideation or past suicide attempts
  • Severe depressive symptoms, as per screening BDI score > 28
  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

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
The individual participant dataset includes de-identified demographic/clinical information obtained from all randomized participants at screening, as well as primary and secondary outcome measures obtained over the course of the 8-week intervention period.

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01210651     History of Changes
Other Study ID Numbers: H49362-35940-01 
Study First Received: September 21, 2010
Results First Received: June 7, 2016
Last Updated: November 14, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Individual participant data from this clinical trial have been de-identified of any protected health information, and made available for sharing with other researchers. The dataset includes demographic/clinical variables obtained from all randomized participants at screening, as well as primary and secondary outcome measures obtained from participants in both intervention groups over the course of the 8-week intervention period. The dataset is accessible as an Excel file via the following web link: http://prathikanti.com/studydata/

Keywords provided by University of California, San Francisco:
Yoga
Major Depression
Self-Efficacy
Self-Esteem
Hatha yoga
mind-body therapies
depression

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

ClinicalTrials.gov processed this record on February 23, 2017