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Culturally Adapted Psychosocial Interventions for Early Psychosis in a Low-resource Setting
Sponsor: Pakistan Institute of Living and Learning
Summary
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 total of N=390 participants with FEP
Official title: Culturally Adapted Psychosocial Interventions for Early Psychosis in a Low-resource Setting: a Large Multi-center Randomised Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
390
Start Date
2024-04-15
Completion Date
2026-12-31
Last Updated
2024-12-12
Healthy Volunteers
Yes
Conditions
Interventions
CaCBT for psychosis
The CaCBT intervention is based on the intervention manual developed by David Kingdon and Douglas Turkington, and culturally adapted by our group. CaCBT aims to take a collaborative approach to gaining an understanding of the symptoms
Culturally adapted Family Intervention (CulFI) for psychosis
CulFI intervention comprises of Family psychoeducation; cognitive-behavioural skills training for stress-management, coping and problem solving; crisis intervention and suicide risk management; relapse prevention; education and support regarding the family environment, including communication training. The components are designed to facilitate an understanding about psychosis, the emotional impact of the illness on family relationships, to promote more adaptive coping strategies and minimize relapse risk.
Locations (1)
Civil hospital
Karachi, Sindh, Pakistan