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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: ameer.bukhsh@pill.org.pk
• Phone: 009235871845

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.