Pilot Study of Adjunctive Yoga for Bipolar Depression

NCT ID: NCT02402010

Last Updated: 2016-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-01-31

Brief Summary

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).

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.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Adjunctive Yoga

Intervention Type: BEHAVIORAL

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.

Group Type: OTHER

Enhanced Treatment as Usual

Intervention Type: BEHAVIORAL

Interventions

Adjunctive Yoga

Intervention Type: BEHAVIORAL

Enhanced Treatment as Usual

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Butler Hospital

OTHER

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Lauren M. Weinstock, PhD

Associate Professor (Research)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Butler Hospital

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

IRB1401-001

Identifier Type: -

Identifier Source: org_study_id