Culturally adapted psychoeducation for bipolar disorder: a multicentre, assessor-masked, randomised controlled trial
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M Ishrat Husain1,2,3, Muqaddas Asif4, Ameer B Khoso4
1Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada.
Background:
Adjunctive psychoeducation can reduce recurrence of mood episodes in bipolar disorder (BD), but evidence from low-resource settings is scarce. We evaluated whether culturally adapted psychoeducation (CaPE) plus treatment-as-usual (TAU) prolongs time to recurrence in adults with BD in remission in Pakistan, a lower-middle-income country.
Methods:
In this multi-centre, assessor-masked randomised controlled trial, adults with remitted bipolar I or II disorder at seven urban centres in Pakistan were randomly assigned to CaPE plus TAU or TAU alone. CaPE comprised 12 weekly individual sessions delivered by master's-level psychologists. The primary outcome was time to recurrence of any mood episode over 48 weeks, assessed with the Longitudinal Interval Follow-up Evaluation. Secondary outcomes included recurrence of depressive and manic/hypomanic episodes and clinical and quality-of-life measures. The trial is registered with ClinicalTrials.gov (NCT05223959).
Findings:
Between June 2022 and March 2025, 303 participants were randomly assigned (148 TAU, 155 CaPE plus TAU); 12-month data were available for 284 of 303 (93.7%). Over 48 weeks, CaPE prolonged time to recurrence of any mood episode versus TAU (adjusted hazard ratio 0.54, 95% CI 0.42-0.69; p < 0.001). At 12 months, CaPE improved recovery (measured with the Bipolar Recovery Questionnaire, on which higher scores indicate greater recovery; adjusted difference 144.8, 95% CI 51.5-238.1; p = 0.002), knowledge and attitudes (78.2, 22.6-133.8; p = 0.006), medication adherence (-0.4, -0.8 to -0.1; p = 0.013), and depressive symptoms (-5.3, -7.8 to -2.7; p < 0.0001). All adjusted estimates account for age, sex assigned at birth, marital status, weeks since diagnosis, and weeks in treatment.
Interpretation:
Individual culturally adapted psychoeducation added to routine care reduced recurrence risk and improved clinical outcomes in Pakistani adults with BD, and could optimise maintenance treatment in Pakistan and other low-resource settings.
Funding:
Canadian Institutes of Health Research.
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Bipolar Disorder
Blinding