Culturally adapted therapies for early psychosis in Pakistan
Culturally Adapted Psychosocial Interventions for Early Psychosis in a Low-resource Setting: a Large Multi-center Randomised Controlled Trial
This study is testing if specially adapted therapy programs can help people in Pakistan who are experiencing their first episode of psychosis feel better compared to standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 390 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pakistan Institute of Living and Learning Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Trial ID | NCT05814913 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of Culturally adapted Cognitive Behavioral Therapy (CaCBT) and Culturally adapted Family Intervention (CulFI) in reducing symptoms of psychosis in individuals experiencing their first episode of psychosis in Pakistan. The study will involve 390 participants who will be randomly assigned to receive either CaCBT, CulFI, or Treatment As Usual (TAU). Participants will undergo a series of therapy sessions delivered by trained psychologists, with assessments conducted at multiple time points to measure outcomes related to psychosis symptoms, quality of life, and caregiver wellbeing. The study also seeks to assess the economic impact of these interventions in a low-resource setting.
Who should consider this trial
Good fit: Ideal candidates include individuals over 18 years old with a confirmed diagnosis of schizophrenia or related disorders, experiencing their first episode of psychosis, and who have a supportive carer willing to participate.
Not a fit: Patients with active substance use disorders or severe cognitive disorganization may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective, culturally tailored interventions for individuals with early psychosis, improving their symptoms and overall quality of life.
How similar studies have performed: While there is limited evidence from low- and middle-income countries regarding the efficacy of these culturally adapted interventions, similar approaches have shown promise in other settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Karachi, Sindh
- Civil hospital — Karachi, Sindh, Pakistan (Recruiting)
Study contacts
- Principal investigator: Omair Husain, MD — Centre for Addiction and Mental Health
- Study coordinator: Ameer B Khoso
- Email: ameer.bukhsh@pill.org.pk
- Phone: 021-35371084
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.