Pilot Study of Adjunctive Yoga for Bipolar Depression

January 11, 2016 updated by: Lauren M. Weinstock, PhD, Brown University
As a practice that incorporates elements of physical exercise, controlled breathing, and meditation, yoga is gaining increasing acceptance as an adjunctive intervention for many psychiatric disorders. Although yoga has been frequently recommended as a symptom management strategy for bipolar disorder (BD), and although there is some preliminary evidence that yoga may be helpful in alleviating depressive symptoms, there are no systematic studies on the benefits - and potential risks - of the practice of yoga in BD. The primary aim of the proposed study is to develop and evaluate the feasibility, acceptability, and safety of an adjunctive yoga intervention for bipolar depression in a 10 week pilot randomized controlled trial (RCT).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Overcoming the burden of depression remains one of the most significant challenges in managing bipolar disorder. Compared to mania, depressive episodes in bipolar disorder are more frequent and considerably longer in length, with individuals spending roughly one-third to one-half of their lives suffering from depressive symptoms. Most of the difficulties with functioning at work, home, or school are due to depressive episodes, and most suicides occur in the context of a depressive (vs. manic) episode. Medication treatment of bipolar depression is not straightforward. Some individuals have a poor response to mood stabilizing medications, experience switches into mania as a result of antidepressant use, and have trouble taking their medications as prescribed. Thus, there remains a need for treatments that individuals with bipolar depression can use in addition to medication. As a practice that incorporates elements of physical exercise, controlled breathing, and meditation, hatha yoga has frequently been recommended as a way to manage bipolar disorder symptoms. There are numerous reasons why hatha yoga may be helpful for bipolar depression. First, there is some evidence that hatha yoga is useful for unipolar depression. Second, it is possible that yoga may help individuals with bipolar disorder regulate their daily routines, decrease negative depressive thoughts, and have a positive impact on biological mechanisms related to bipolar disorder. Yet to our knowledge, there have been no published studies on the benefits - and potential risks - of the practice of yoga in bipolar disorder. The primary aim of the proposed pilot study is to develop a 10 week yoga program specifically tailored to bipolar depression. We will develop an instructor manual for teaching classes and a scale for measuring instructor adherence to the manual. We will evaluate the feasibility, acceptability to patients, and safety of this program in a 10 week pilot randomized controlled trial (RCT). In this trial, we will enroll 36 participants with bipolar I/II depression, and randomly assign them to either: 1) the yoga intervention, delivered as an adjunct to treatment as usual; or 2) treatment as usual enhanced with a publicly-available bipolar disorder self-help book (ETAU). In a preliminary fashion, we will examine whether the yoga classes (compared to ETAU) appear promising in terms of reduced symptom severity and improved quality of life.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • DSM-IV diagnosis of bipolar I or II disorder
  • current major depressive episode
  • at least 4 weeks of stable medication treatment as usual
  • medical clearance for moderate exercise, as documented in a note from a primary care provider
  • ability to understand English sufficiently well to understand consent or assessment instruments

Exclusion Criteria:

  • presence of psychiatric symptoms severe enough to warrant inpatient hospitalization
  • current psychotic symptoms
  • active alcohol or substance use disorder
  • pregnancy or plans to become pregnant within the year
  • participation in more than 4 single sessions of yoga in the past 2 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adjunctive Yoga
Participants may be randomized to receive up to 10 weeks of group yoga class, as an adjunct to medication treatment as usual provided by community clinicians.
Behavioral: Adjunctive Yoga
Other: Enhanced Treatment as Usual
Those randomized to the Enhanced Treatment as Usual arm will follow their usual treatment plans in the community, with enhanced monitoring of symptoms and functioning through regular study assessments. With a release of information, we will provide community clinicians with a standardized report that summarizes level of symptom severity and risk, designed to aid in continuity of care.
Behavioral: Enhanced Treatment as Usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quick Inventory of Depressive Symptomatology-Clinician Administered
Time Frame: 10 weeks
10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Altman Self-Rating Mania Scale
Time Frame: 10 weeks
10 weeks
World Health Organization (WHO) Disability Assessment Schedule-II
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brown University

Collaborators

Butler Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

March 25, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimate)

March 30, 2015

Study Record Updates

Last Update Posted (Estimate)

January 12, 2016

Last Update Submitted That Met QC Criteria

January 11, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB1401-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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