Culturally adapted cognitive behavioral therapy for people at risk of a first episode psychosis

Culturally Adapted Cognitive Behavior Therapy for Individuals At Risk of First Episode Psychosis: A Mixed Method Study

This project will try a culturally adapted form of cognitive behavioral therapy to see if it helps young people in Pakistan who are at high risk of a first episode of psychosis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 16 Years to 35 Years
• Sex: All
• Sponsor: Pakistan Institute of Living and Learning (Academic / other)
• Locations: 2 sites (Karachi, Sindh and 1 other locations)
• Trial ID: NCT07188597 on ClinicalTrials.gov

What this trial studies

The project will culturally adapt an evidence-based CBT package for At-Risk Mental State (ARMS) and then field-test the adapted intervention in a randomized controlled trial among help-seeking 16–35-year-olds in Karachi. Eligible participants (PQ-16 ≥6 and meeting CAARMS ARMS criteria) will be randomized to receive the adapted CBT plus usual care or usual care alone, with follow-up to measure transition to psychosis, mood and anxiety symptoms, and functioning. Feasibility and acceptability will be tracked via recruitment rates, session attendance (target >70%), assessment completion, participant satisfaction, and attrition. The study will also collect qualitative feedback from patients, families, and clinicians about perceived usefulness and barriers to delivery.

Who should consider this trial

Good fit: Ideal candidates are help-seeking males or females aged 16–35 in Karachi who score ≥6 on the PQ-16, meet CAARMS criteria for ARMS, can provide informed consent, and are able to attend therapy and follow-up.

Not a fit: People with a prior history of treated or untreated psychotic illness, prior antipsychotic or mood-stabilizer treatment, recent substance dependence (except nicotine or caffeine), temporary residents unlikely to complete follow-up, or those unable to engage with therapy are unlikely to benefit.

Why it matters

Potential benefit: If successful, this intervention could reduce or delay transition to psychosis and improve symptoms and functioning while offering a culturally acceptable therapy option for young people in Pakistan.

How similar studies have performed: Previous randomized trials have shown that CBT can delay or reduce transition to psychosis in ARMS populations, but culturally adapted CBT in Pakistan is novel and less well studied.

Eligibility criteria

Inclusion Criteria:

* Male or female help-seeking individual aged 16-35 years;
* Score 6 or above on PQ-16
* Meet the at risk of FEP criteria using CAARMS Operationalized Intake Criteria based on three groups (vulnerability, attenuated psychosis or brief limited intermittent psychotic symptoms group);
* Assessed as competent to provide informed consent.
* Give written informed consent.

Exclusion Criteria:

* Temporary resident unlikely to be available for follow up.
* Unable to engage, participate or respond to research questionnaires.
* a history of psychotic illness (treated or untreated).
* previous treatment with an antipsychotic or mood-stabilising agent.
* active substance abuse (except nicotine or caffeine) or dependence within the last three months, according to DSM-V criteria.

Where this trial is running

Karachi, Sindh and 1 other locations

• Commuity/Schools/Colleges — Karachi, Sindh, Pakistan (Recruiting)
• Karwan e Hayat — Karachi, Sindh, Pakistan (Recruiting)

Study contacts

• Principal investigator: Ameer B Khoso, PhD — Pakistan Institute of Living and Learning
• Study coordinator: Ameer B Khoso, PhD Fellow

Conditions Individuals at Risk of First Episode Psychosis