Culturally adapted psychoeducation for bipolar disorder: a multicentre, assessor-masked, randomised controlled trial

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.