Development Validation and Feasibility testing of a yoga based intervention for bipolar affective disorder

This prospective study is designed to develop, validate, and assess the feasibility of a structured yoga-based intervention tailored for individuals with Bipolar Affective Disorder (BPAD). The yoga module will be developed through a comprehensive review of both classical and contemporary yoga literature. Following its development, the draft module will be subjected to expert validation. Qualified yoga experts meeting predefined inclusion criteria will be invited to review the module and rate each practice for its relevance and appropriateness. Content Validity Ratio for each practice will be calculated using Lawshe’s formula. Practices meeting the required CVR threshold will be retained in the final version of the module. Feasibility testing will be conducted on a cohort of 20 patients diagnosed with BPAD, as per DSM-5 diagnostic criteria, confirmed by a qualified psychiatrist. The feasibility phase will follow a single-group, pre-post design, with baseline assessments conducted prior to the intervention and post-assessments following its completion. Participants will undergo a total of 10 yoga sessions over 2 weeks.

This will be followed by efficacy testing of the developed module on (a) time to recurrence of an episode of bipolar disorder of sufficient severity to reach DSM–V criteria for major depressive, hypomania, mania or mixed episode, based on the SCID interview

(b) a longitudinal severity rating of overall symptom levels for each week since the last assessment interview (2 months), based on the Longitudinal Interval Follow-up Evaluation (LIFE–II; Keller et al, Reference Keller, Lavori and Friedman1987, Reference Keller, Lavori and Kane1992). Two LIFE scores will be included, one for mania and one for depression and both employed a six-point scale (1=no symptoms, through to 6=DSM–V major depressive episode or mania with psychotic symptoms or severe impairment of function); secondary outcome variables of social adjustment and quality of life and yoga performance scale.