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The aim of this study is to evaluate the clinical and economic impact of culturally adapted CBT (CaCBT) and culturally adapted family intervention (CulFI) in the context of Pakistan.
This is a multi-center, three-arm randomized controlled trial (RCT) involving 390 participants with first episode psychosis. Participants are being recruited from multiple clinical centres across Pakistan and randomized to one of three study arms: CaCBT, CulFI, or treatment as usual (TAU). The primary objective of the trial is to assess the reduction in overall psychotic symptomatology. Secondary aims include evaluating improvements in patient-specific outcomes—such as positive and negative symptoms, general psychopathology, depressive symptoms, cognitive functioning, insight, and quality of life—as well as carer related outcomes including carer experience, psychological wellbeing, illness perceptions, and symptoms of anxiety and depression. This trial will provide robust evidence on the clinical efficacy and cost-effectiveness of culturally tailored psychosocial interventions for FEP in a low-resource setting.
The findings have the potential to inform policy and practice by supporting the scalable implementation of these interventions across South Asia and other LMICs, ultimately improving clinical and functional outcomes for individuals
with early psychos is in underserved populations.