Culturally adapted therapies for early psychosis in Pakistan

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of Culturally adapted Cognitive Behavioral Therapy (CaCBT) and Culturally adapted Family Intervention (CulFI) in reducing symptoms of psychosis in individuals experiencing their first episode of psychosis in Pakistan. The study will involve 390 participants who will be randomly assigned to receive either CaCBT, CulFI, or Treatment As Usual (TAU). Participants will undergo a series of therapy sessions delivered by trained psychologists, with assessments conducted at multiple time points to measure outcomes related to psychosis symptoms, quality of life, and caregiver wellbeing. The study also seeks to assess the economic impact of these interventions in a low-resource setting.

Why it matters

Who can join: the full rules

Inclusion Criteria for patient participants:

* Individuals of all genders aged over 18 years; diagnosis of schizophrenia confirmed by Structured Clinical Interview for DSM (SCID) meeting DSM-5 criteria for schizophrenia, schizophreniform or schizoaffective psychosis
* Scored at least 4 on the PANSS delusions or hallucinations items, or at least 5 on suspiciousness, persecution, or grandiosity items
* stable on medication for the past four weeks
* in contact with mental health services
* within 3 years of diagnosis
* able to demonstrate the capacity to provide informed consent to take part in the study
* potential participants must have a carer or relative who is also willing to participate in the study to be eligible

Exclusion Criteria for patient participants:

* Active DSM-5 substance use disorder (except nicotine or caffeine) or dependence within the last three months
* A score of 5 or more on the PANSS conceptual disorganisation item
* Individuals who have received structured psychological intervention within the past 3 months
* Relevant CNS or other medical disorders that would impact participation
* Diagnosis of intellectual disability
* Unstable residential arrangements

Family member/Carer participant inclusion criteria:

* Living with or spending at least 10 hours per week in face-to-face contact with an individual with early psychosis and assuming a caring role
* Age\>18 years
* Able to give informed written consent.

Family member/Carer participant exclusion criteria:

* Active DSM-5 substance use disorder
* Received psychological intervention within the past 3 months
* Unstable residential arrangements.

Where it's running

• Civil hospital
  Karachi, Sindh, Pakistan Recruiting

Study contacts

• Principal investigator: Omair Husain, MD — Centre for Addiction and Mental Health
• Study coordinator: Ameer B Khoso
• Email: ameer.bukhsh@pill.org.pk
• Phone: 021-35371084

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.