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

NCT07188597 | Recruiting DMC

• 1 other identifier: PILL-CBT ARMS-FEP
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Individuals at Risk of First Episode Psychosis

Outcome Measures

Primary Outcomes (2)

• Feasibility Indicator

  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

  From baseline to 12th week (end of intervention)

• Acceptability Indicator

  Intervention acceptability will be assessed using data on attendance. Criterion for acceptability is a mean attendance rate of \>70%.

  From baseline to 12th week (end of intervention)

Other Outcomes (9)

• The Prodromal Questionnaire

  From baseline to 12th week (end of intervention)

• Brief-Comprehensive Assessment of At-Risk Mental States

  From baseline to 12th week (end of intervention)

• Client Satisfaction Questionnaire

  From baseline to 12th week (end of intervention)

Study Arms (2)

Cognitive Behavior Therapy for those at risk of first episode psychosis

EXPERIMENTAL

The participants in the intervention group will receive a culturally adapted manualised cognitive behavioral therapy (CBT). The interventions aim to reduce symptoms, normalises psychosis-like experiences and prevents a catastrophic appraisal of the psychotic-like symptoms from occurring

Behavioral: Cognitive Behavior Therapy for those at risk of first episode psychosis

Treatment as Usual

NO INTERVENTION

Treatment As Usual (TAU): Local medical, psychiatric and primary care services provide standard routine care according to their clinical judgment and available resources. These participants will receive an initial assessment along with TAU as ascertained by their treating doctor at the hospital. In current practice, individuals with ARMS (at risk of first episode psychosis) are not routinely referred to any psychological service in Pakistan. TAU in Pakistan largely comprises of pharmacotherapy. Research staff will record the nature and intensity of the routine care delivered for each participant.

Interventions

Cognitive Behavior Therapy for those at risk of first episode psychosis BEHAVIORAL

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.

Also known as: CBT-FEP

Cognitive Behavior Therapy for those at risk of first episode psychosis

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead

Study Sites (2)

Commuity/Schools/Colleges

Karachi, Sindh, Pakistan

RECRUITING

Karwan e Hayat

Karachi, Sindh, Pakistan

RECRUITING

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ameer B Khoso, PhD

  Pakistan Institute of Living and Learning

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ameer B Khoso, PhD Fellow

CONTACT

009235871845; ameer.bukhsh@pill.org.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Researchers conducting outcome assessments will be blind to treatment allocations
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cognitive Behavior Therapy for those at risk of first episode psychosis- "evidence-based therapy for people with ARMS" (Van der Gaag, et al., 2013). The participants in the intervention group will receive a culturally adapted manualised cognitive behavioral therapy (CBT). The interventions aim to reduce symptoms, normalises psychosis-like experiences and prevents a catastrophic appraisal of the psychotic-like symptoms from occurring.

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 23, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

PA (2)