Actively Recruiting

Phase Not Applicable
Age: 16Years - 35Years
All Genders
NCT07188597

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

Led by Pakistan Institute of Living and Learning · Updated on 2026-04-13

90

Participants Needed

2

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years - 35Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female help-seeking individual aged 16-35 years
  • Score 6 or above on PQ-16
  • Meet the at risk of first episode psychosis criteria using CAARMS Operationalized Intake Criteria based on vulnerability, attenuated psychosis, or brief limited intermittent psychotic symptoms groups
  • Assessed as competent to provide informed consent
  • Provide written informed consent
Not Eligible

You will not qualify if you...

  • Temporary resident unlikely to be available for follow-up
  • Unable to engage, participate, or respond to research questionnaires
  • 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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Commuity/Schools/Colleges

Karachi, Sindh, Pakistan

Actively Recruiting

2

Karwan e Hayat

Karachi, Sindh, Pakistan

Actively Recruiting

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Research Team

A

Ameer B Khoso, PhD Fellow

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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