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

Inclusion Criteria10

Individuals of all genders aged over 18 years; diagnosis of schizophrenia confirmed by Structured Clinical Interview for DSM (SCID) meeting DSM-5 criteria for schizophrenia, schizophreniform or schizoaffective psychosis
Scored at least 4 on the PANSS delusions or hallucinations items, or at least 5 on suspiciousness, persecution, or grandiosity items
stable on medication for the past four weeks
in contact with mental health services
within 3 years of diagnosis
able to demonstrate the capacity to provide informed consent to take part in the study
potential participants must have a carer or relative who is also willing to participate in the study to be eligible
Living with or spending at least 10 hours per week in face-to-face contact with an individual with early psychosis and assuming a caring role
Age\>18 years
Able to give informed written consent.

Exclusion Criteria9

Active DSM-5 substance use disorder (except nicotine or caffeine) or dependence within the last three months
A score of 5 or more on the PANSS conceptual disorganisation item
Individuals who have received structured psychological intervention within the past 3 months
Relevant CNS or other medical disorders that would impact participation
Diagnosis of intellectual disability
Unstable residential arrangements
Active DSM-5 substance use disorder
Received psychological intervention within the past 3 months
Unstable residential arrangements.

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.