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

NCT01210651 | Completed Results

• 1 other identifier: H49362-35940-01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression, Unipolar

Keywords

Yoga; Major Depression; Self-Efficacy; Self-Esteem; Hatha yoga; mind-body therapies; depression

Outcome Measures

Primary Outcomes (3)

• Intent-to-Treat Analysis of Adjusted Mean Beck Depression Inventory-II Scores Over Intervention Period

  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.

  0 wks, 2 wks, 4 wks, 6 wks, 8 wks

• Total Change Scores on Beck Depression Inventory-II Among Study Completers

  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.

  0 wks and 8 wks

• Number of Study Completers With Remitted Depression, Per Completers Analysis of BDI Scores at 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.

  8 Weeks

Secondary Outcomes (2)

• Total Change Scores on General Self-Efficacy Scale (GSES) Among Study Completers

  0 wks, 8 wks

• Total Change Scores on Rosenberg Self-Esteem Scale (RSES) Among Study Completers

  0 wks, 8 wks

Study Arms (2)

Hatha Yoga Practice Group

EXPERIMENTAL

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

Attention Control Education Group

ACTIVE COMPARATOR

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

Interventions

Hatha Yoga Practice Group BEHAVIORAL

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.

Also known as: Yoga Practice Group, Hatha Yoga Group, Yoga Exercise Group

Hatha Yoga Practice Group

Attention Control Education Group BEHAVIORAL

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.

Also known as: Attention Control Group, Education Group, Yoga History Group

Attention Control Education Group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Mental Insight Foundation: collaborator
• Pritzker Family Foundation: collaborator
• Mount Zion Health Fund: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94115, United States

Location

Related Publications (1)

• Prathikanti S, Rivera R, Cochran A, Tungol JG, Fayazmanesh N, Weinmann E. Treating major depression with yoga: A prospective, randomized, controlled pilot trial. PLoS One. 2017 Mar 16;12(3):e0173869. doi: 10.1371/journal.pone.0173869. eCollection 2017.

  PMID: 28301561 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

Small sample size; not possible to blind participants to intervention; sub-optimal adherence/completion rates, especially in attention control group; however, adherence/completion rates comparable to many exercise-based interventions for depression.

Results Point of Contact

• Title: Sudha Prathikanti, MD
• Organization: UCSF

sudha.prathikanti@gmail.com

415-516-3867

Study Officials

• Sudha Prathikanti, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2010
• First Posted: September 28, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: January 11, 2017
• Results First Posted: January 11, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)