Culturally Adapted Cognitive Behavior Therapy for Individuals At Risk of First Episode Psychosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Behavior Therapy for those at risk of first episode psychosis.
- Who it may be relevant to
- Registry conditions: Individuals at Risk of First Episode Psychosis. Basic parameters: 16 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Culturally Adapted Cognitive Behavior Therapy for Individuals At Risk of First Episode Psychosis: A Mixed Method Study
Overview
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
Interventions
- 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
Primary outcome measures
- Feasibility Indicator [Time frame: From baseline to 12th week (end of intervention)]
- Acceptability Indicator [Time frame: From baseline to 12th week (end of intervention)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Pakistan · 2 centers
- Commuity/Schools/Colleges — Karachi
- Karwan e Hayat — Karachi
Identifiers
NCT: NCT07188597 · PILL-CBT ARMS-FEP