Pilot Study of Adjunctive Yoga for Bipolar Depression



Status:Completed
Conditions:Psychiatric, Bipolar Disorder
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2014
End Date:January 2016

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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).

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.

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
We found this trial at
1
site
345 Blackstone Blvd
Providence, Rhode Island 02906
(401) 455-6200
Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
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mi
from
Providence, RI
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