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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-35
SponsorPakistan Institute of Living and Learning

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Cognitive Behavior Therapy for those at risk of first episode psychosisExperimental treatment 1 intervention
Group B: Treatment as UsualNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
From baseline to 12th week (end of intervention)
2

Acceptability Indicator

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

Time frame
From baseline to 12th week (end of intervention)

Secondary outcomes

Other outcomes

1

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

Time frame
From baseline to 12th week (end of intervention)
2

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.

Time frame
From baseline to 12th week (end of intervention)
3

Client Satisfaction Questionnaire

The participants will rate their satisfaction with treatment at 3 months (after completion of the intervention) using the CSQ

Time frame
From baseline to 12th week (end of intervention)
4

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

Time frame
From baseline to 12th week (end of intervention)

Sponsors and contacts

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