Pilot Study of Adjunctive Yoga for Bipolar Depression

Bipolar Disorder Clinical Trial

Official title:

Pilot Study of Adjunctive Yoga for Bipolar Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02402010
• Other study ID #: IRB1401-001
• Status: Completed
• Phase: N/A
• First received: March 25, 2015
• Last updated: January 11, 2016
• Start date: January 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Behavioral:
• Adjunctive Yoga

• Enhanced Treatment as Usual

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	Butler Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quick Inventory of Depressive Symptomatology-Clinician Administered		10 weeks	No
Secondary	Altman Self-Rating Mania Scale		10 weeks	No
Secondary	World Health Organization (WHO) Disability Assessment Schedule-II		10 weeks	No