Culturally Adapted Psychosocial Interventions for Early Psychosis in a Low-resource Setting
Recruiting · NCT05814913 · Interventional (participants receive a specific treatment) · Lead sponsor: Pakistan Institute of Living and Learning
View the official record on ClinicalTrials.gov →Interventions studied
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
Who can take part
Inclusion criteria
- for patient participants:
- 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
Exclusion criteria
- for patient participants:
- 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
- Family member/Carer participant inclusion criteria:
- 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.
- Family member/Carer participant exclusion criteria:
- Active DSM-5 substance use disorder
- Received psychological intervention within the past 3 months
- Unstable residential arrangements.
Where it is running
1 location listed.
- Civil hospital - Karachi, Sindh, Pakistan