An interventional study of Cognitive Behavior Therapy for those at risk of first episode psychosis in Individuals at Risk of First Episode Psychosis, sponsored by Pakistan Institute of Living and Learning. Recruiting at 2 sites in Pakistan. Open to participants aged 16 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Pakistan Institute of Living and Learning · Not applicable, Interventional, and Treatment
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.
Aims and Objectives:
The study has following aims and objectives:
Feasibility and acceptability of the intervention is defined as:
Completeness of assessment tools and the assessment schedule by participants
Exclusion Criteria:
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 (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.
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
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)
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)
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)
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)
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)
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)
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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: From baseline to 12th week (end of intervention)
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Pakistan Institute of Living and Learning