NCT07188597

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Pakistan Institute of Living and Learning · Academic / Other
• Sex: All
• Age: 16 Years – 35 Years
• Healthy volunteers: Not accepted

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

Conditions

• Individuals at Risk of First Episode Psychosis

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavior Therapy for those at risk of first episode psychosis	Participants will receive a culturally adapted manualised Cognitive Behavioural Therapy (CBT) for those at risk of first episode psychosis (FEP). The intervention aims to reduce symptoms, normalise psychosis-like experiences, and prevent catastrophic appraisals that may lead to delusions. It integrates psychoeducation, behavioural experiments, and techniques addressing cognitive biases. By reframing unusual experiences as perceptual or reasoning biases, distress and emotional arousal are reduced, lowering the chance of fixed, frightening beliefs. Homework tasks further support coping. CBT for At-Risk Mental States has shown effectiveness in reducing transition to psychosis and improving recovery. This study will adapt and field test the manual, with potential for remote delivery via phone, video, or AI tools to enhance accessibility.

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-06-30
• Completion: 2026-12-30
• First posted: 2025-09-23
• Last updated: 2026-04-13

Locations

2 sites across 1 country: Pakistan