Culturally Adapted Cognitive Behavior Therapy for Individuals At Risk of First Episode Psychosis: A Mixed Method Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 35
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Pakistan
Commuity/Schools/Colleges
RECRUITING
Karachi
Karwan e Hayat
RECRUITING
Karachi
Contact Information
Primary
Ameer B Khoso, PhD Fellow
ameer.bukhsh@pill.org.pk
009235871845
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 90
Treatments
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
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.
Related Therapeutic Areas
Sponsors
Leads: Pakistan Institute of Living and Learning

This content was sourced from clinicaltrials.gov