Actively Recruiting
Culturally Adapted Psychosocial Interventions for Early Psychosis in a Low-resource Setting
Led by Pakistan Institute of Living and Learning · Updated on 2024-12-12
390
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
Sponsors
P
Pakistan Institute of Living and Learning
Lead Sponsor
C
Centre for Addiction and Mental Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Culturally Adapted Psychosocial Interventions for Early Psychosis in a Low-resource Setting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals of all genders aged over 18 years
- Diagnosis of schizophrenia, schizophreniform, or schizoaffective psychosis confirmed by Structured Clinical Interview for DSM (SCID) meeting DSM-5 criteria
- 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
- Currently in contact with mental health services
- Within 3 years of diagnosis
- Able to provide informed consent to participate
- Must have a carer or relative willing to participate in the study
- Family members/carers must be aged over 18 years
- Family members/carers must live with or spend at least 10 hours per week in face-to-face contact with the participant and assume a caring role
- Family members/carers must be able to provide informed written consent
You will not qualify if you...
- Active DSM-5 substance use disorder (except nicotine or caffeine) or dependence within the last three months
- Score of 5 or more on the PANSS conceptual disorganisation item
- Received structured psychological intervention within the past 3 months
- Relevant central nervous system or other medical disorders impacting participation
- Diagnosis of intellectual disability
- Unstable residential arrangements
- Family members/carers with active DSM-5 substance use disorder
- Family members/carers who received psychological intervention within the past 3 months
- Family members/carers with unstable residential arrangements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Civil hospital
Karachi, Sindh, Pakistan, 75600
Actively Recruiting
Research Team
A
Ameer B Khoso
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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