Pilot Study of Adjunctive Yoga for Bipolar Depression

NCT02402010 | Completed

• 1 other identifier: IRB1401-001
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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).

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Quick Inventory of Depressive Symptomatology-Clinician Administered

  10 weeks

Secondary Outcomes (2)

• Altman Self-Rating Mania Scale

  10 weeks

• World Health Organization (WHO) Disability Assessment Schedule-II

  10 weeks

Study Arms (2)

Adjunctive Yoga

EXPERIMENTAL

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

Enhanced Treatment as Usual

OTHER

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

Interventions

Adjunctive Yoga BEHAVIORAL

Adjunctive Yoga

Enhanced Treatment as Usual BEHAVIORAL

Enhanced Treatment as Usual

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown University: lead
• Butler Hospital: collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Research)

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: March 30, 2015
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

US (1)