Culturally Adapted Cognitive Behavior Therapy for Individuals At Risk of First Episode Psychosis

Not Applicable

Recruiting

• Conditions: Individuals at Risk of First Episode Psychosis

• Registration Number: NCT07188597
• Lead Sponsor: Pakistan Institute of Living and Learning

Brief Summary

Young people constitute nearly half of Pakistan's population and are highly vulnerable to risk factors for mental illness, including poverty, inequality, abuse, and violence. Estimates suggest that 19-34% of children and adolescents experience emotional or behavioural disorders, though this is likely underestimated. In recent years, research has focused on those at imminent risk of developing serious conditions such as first episode psychosis. The concept of an At-Risk Mental State (ARMS) has highlighted the urgent need for interventions that address current symptoms, improve functioning, and reduce transition to psychosis.

Up to 80% of young people with ARMS have another diagnosable condition, and almost half show poor psychosocial outcomes even six years after initial help-seeking. Evidence demonstrates that early identification and treatment can delay or prevent psychosis, including severe and enduring illnesses like schizophrenia. Cognitive Behaviour Therapy (CBT) is among the most effective evidence-based approaches for this group. However, existing evidence comes largely from high-income countries, raising concerns about cultural applicability in low-resource settings.

This study will culturally adapt and field test a manualised CBT intervention for young people at risk of first episode psychosis. To our knowledge, this is the first such study in a low-income country. Findings will inform scalable, culturally relevant interventions for Pakistan and similar contexts.

Detailed Description

Aims and Objectives:

The study has following aims and objectives:

1. To culturally adapt the existing Cognitive Behavior Therapy for those at risk of first episode psychosis- "evidence-based therapy for people with ARMS" (Van der Gaag, et al., 2013).

2. To field test the culturally adapted intervention in a randomised controlled trial

3. To check whether adapted intervention reduces or delay the rates or incidence of transition from ARMS to first episode psychosis;

4. To check whether adapted intervention improves other symptoms such as depression, anxiety and/or level of functioning in ARMS

5. To explore the pereceived usefulness of intervention including perceived barriers and facilitators from different stakeholders' perspective.

Feasibility and acceptability of the intervention is defined as:

* Recruitment rates, attendance (attending more than 70% of intervention sessions)

* Acceptability of the intervention (based on participants satisfaction, attendance, attrition rates)

* Completeness of assessment tools and the assessment schedule by participants

* Preliminary efficacy of the intervention

Study Timeline

• Study Start: 2025-01-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-16
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-23
• Last Update Posted: 2025-09-23
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility Indicator	From baseline to 12th week (end of intervention)	feasibility will be determined by collecting data on recruitment and retention rates, The success criterion of feasibility will be to recruit \> 50% of eligible participants
Acceptability Indicator	From baseline to 12th week (end of intervention)	Intervention acceptability will be assessed using data on attendance. Criterion for acceptability is a mean attendance rate of \>70%.

Trial Locations

Locations (2)

Commuity/Schools/Colleges; 🇵🇰 Karachi, Sindh, Pakistan

Karwan e Hayat; 🇵🇰 Karachi, Sindh, Pakistan