Condition: Psychosis · Sponsor: Pakistan Institute of Living and Learning
Primary Aims: To determine the clinical efficacy of Culturally adapted Cognitive Behavioral Therapy (CaCBT) and Culturally adapted Family Intervention (CulFI) compared to Treatment As Usual (TAU) on reducing overall symptoms of psychosis in patients with First Episode Psychosis (FEP) in Pakistan. Secondary Aims: 1. To determine the efficacy of CaCBT and CulFI compared to TAU on positive and negative symptoms of psychosis, general psychopathology, depressive symptoms, quality of life, general functioning, and insight in patients with FEP in Pakistan. 2. To determine the efficacy of CaCBT and CulFI compared to TAU on improving carer experience, carer wellbeing, carer illness attitudes and symptoms of depression and anxiety in family and carers of patients with FEP in Pakistan. 3. To determine the comparative effect of CaCBT and CulFI in improving patient and carer related outcomes in individuals with FEP in Pakistan. 4. To estimate the economic impact of delivering culturally appropriate psychosocial interventions in low-resource settings 5. To explore delivery and reach of each intervention, tolerability of intervention components, acceptability of interventions, understanding mechanism of change and developing an understanding of barriers and facilitators to future adoption using process evaluation. Study design and setting: This will be a multi-centre, assessor masked, individual, three-arm randomised controlled trial (RCT). Sample Size: The study aims to recruit a to…
This description comes directly from the study's public registry record.
Ameer B Khoso · 021-35371084 · ameer.bukhsh@pill.org.pk
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| Civil hospital | Karachi, Sindh, Pakistan | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05814913