RecruitingNot ApplicableNCT05814913

Culturally Adapted Psychosocial Interventions for Early Psychosis in a Low-resource Setting

Culturally Adapted Psychosocial Interventions for Early Psychosis in a Low-resource Setting: a Large Multi-center Randomised Controlled Trial

Sponsor

Pakistan Institute of Living and Learning

Enrollment

390 participants

Start Date

Apr 15, 2024

Study Type

INTERVENTIONAL

Conditions

Psychosis

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a culturally adapted psychosocial program for people in a low-resource setting who are in the early stages of psychosis, to help them recover, maintain their medications, and reintegrate into daily life alongside standard psychiatric care. **You may be eligible if (patient)...** - You are over 18 years old, of any gender - You have a confirmed diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder (per DSM-5) - You are experiencing active psychotic symptoms (hallucinations or delusions rated at moderate severity or above) - You have been stable on medication for at least 4 weeks - You are connected with mental health services **You may NOT be eligible if...** - You are under 18 - You have not been on stable medication for at least 4 weeks - You have a severe medical condition preventing participation - You are not in contact with mental health services Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCaCBT 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

BEHAVIORALCulturally 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.