NCT05814913Recruiting
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
Source: ClinicalTrials.gov · Last updated 12 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 390 (estimated)
- First submitted
- 3 Apr 2023
- Start date
- 15 Apr 2024
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Pakistan Institute of Living and Learning
- Diseases
- Schizophrenia
- NCT number
- NCT05814913
What you commit to
- Study type: Interventional
- Planned participants: 390
- From 15 Apr 2024 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals who have received structured psychological intervention within the past 3 months
- Received psychological intervention within the past 3 months
Other illness
- Active DSM-5 substance use disorder (except nicotine or caffeine) or dependence within the last three months
- Relevant CNS or other medical disorders that would impact participation
- Active DSM-5 substance use disorder
Age
- Age\>18 years
Other
- A score of 5 or more on the PANSS conceptual disorganisation item
- 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
- Able to give informed written consent.
- Family member/Carer participant exclusion criteria:
- Unstable residential arrangements.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Civil Hospital Coordinator of this site? Confirm its status | Karachi | Pakistan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.