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

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.

Study Overview

• Status: Recruiting
• Conditions: Individuals at Risk of First Episode Psychosis
• Intervention / Treatment: Behavioral: Cognitive Behavior Therapy for those at risk of first episode psychosis

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ameer B Khoso, PhD Fellow; Phone Number: 009235871845; Email: ameer.bukhsh@pill.org.pk

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Behavior Therapy for those at risk of first episode psychosis; 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; 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.; Other Names: CBT-FEP
No Intervention: Treatment as Usual; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Prodromal Questionnaire	A brief 16-item self-report screening questionnaire assesses the presence of attenuated psychotic symptoms on a two-point scale (true/false) followed by a 4-point distress rating for each item. A cut of 6 or above considered for further assessment to confirm at risk criteria	From baseline to 12th week (end of intervention)
Brief-Comprehensive Assessment of At-Risk Mental States	A semi-structured interview that assists in the identification of individuals at risk of developing a first-episode psychotic disorder.	From baseline to 12th week (end of intervention)
Client Satisfaction Questionnaire	The participants will rate their satisfaction with treatment at 3 months (after completion of the intervention) using the CSQ	From baseline to 12th week (end of intervention)
Calgary Depression Scale	The Calgary Depression Scale for Schizophrenia (CDSS) is a depression rating scale especially developed for assessing depression in schizophrenia. Higher score shows higher depression	From baseline to 12th week (end of intervention)
Health Related Quality of Life EQ-5D-5L	The EQ-5D is a generic instrument for describing and valuing health. It is based on a descriptive system that defines health in terms of 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response categories corresponding to no problems, some problems, and extreme problems	From baseline to 12th week (end of intervention)
Generalized Anxiety Disorder (GAD-7)	GAD-7 is a brief scale to identify probable cases of generalised anxiety and depression, as well as assessing symptom severity. Higher scores shows greator severity of anxiety	From baseline to 12th week (end of intervention)
Social and Occupational Functioning Scale (SOFAS)	SOFAS will be used to assess overall functioning in a single score (0-100). It is a global rating of current functioning; this instrument focuses on social and occupational functioning that is independent of the overall severity of the individual's psychological symptoms.	From baseline to 12th week (end of intervention)
Brief Illness Perception Questionnaire	a nine-item scale designed to rapidly assess the cognitive and emotional representations of illness	From baseline to 12th week (end of intervention)
Kessler Psychological Distress Scale	Level of distress will be assessed using a 10-item scale the "Kessler Psychological Distress Scale	From baseline to 12th week (end of intervention)

Collaborators and Investigators

• Sponsor: Pakistan Institute of Living and Learning
• Investigators: Principal Investigator: Ameer B Khoso, PhD, Pakistan Institute of Living and Learning

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: September 16, 2025
• First Submitted That Met QC Criteria: September 16, 2025
• First Posted (Actual): September 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy
• Other Study ID Numbers: PILL-CBT ARMS-FEP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No