Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT05814913

Culturally Adapted Psychosocial Interventions for Early Psychosis in a Low-resource Setting

Led by Pakistan Institute of Living and Learning · Updated on 2024-12-12

390

Participants Needed

1

Research Sites

141 weeks

Total Duration

On this page

Sponsors

P

Pakistan Institute of Living and Learning

Lead Sponsor

C

Centre for Addiction and Mental Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

Primary Aims: To determine the clinical efficacy of Culturally adapted Cognitive Behavioral Therapy (CaCBT) and Culturally adapted Family Intervention (CulFI) compared to Treatment As Usual (TAU) on reducing overall symptoms of psychosis in patients with First Episode Psychosis (FEP) in Pakistan. Secondary Aims: 1. To determine the efficacy of CaCBT and CulFI compared to TAU on positive and negative symptoms of psychosis, general psychopathology, depressive symptoms, quality of life, general functioning, and insight in patients with FEP in Pakistan. 2. To determine the efficacy of CaCBT and CulFI compared to TAU on improving carer experience, carer wellbeing, carer illness attitudes and symptoms of depression and anxiety in family and carers of patients with FEP in Pakistan. 3. To determine the comparative effect of CaCBT and CulFI in improving patient and carer related outcomes in individuals with FEP in Pakistan. 4. To estimate the economic impact of delivering culturally appropriate psychosocial interventions in low-resource settings 5. To explore delivery and reach of each intervention, tolerability of intervention components, acceptability of interventions, understanding mechanism of change and developing an understanding of barriers and facilitators to future adoption using process evaluation. Study design and setting: This will be a multi-centre, assessor masked, individual, three-arm randomised controlled trial (RCT). Sample Size: The study aims to recruit a total of N=390 participants with FEP

CONDITIONS

Official Title

Culturally Adapted Psychosocial Interventions for Early Psychosis in a Low-resource Setting

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals of all genders aged over 18 years
  • Diagnosis of schizophrenia, schizophreniform, or schizoaffective psychosis confirmed by Structured Clinical Interview for DSM (SCID) meeting DSM-5 criteria
  • 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
  • Currently in contact with mental health services
  • Within 3 years of diagnosis
  • Able to provide informed consent to participate
  • Must have a carer or relative willing to participate in the study
  • Family members/carers must be aged over 18 years
  • Family members/carers must live with or spend at least 10 hours per week in face-to-face contact with the participant and assume a caring role
  • Family members/carers must be able to provide informed written consent
Not Eligible

You will not qualify if you...

  • Active DSM-5 substance use disorder (except nicotine or caffeine) or dependence within the last three months
  • Score of 5 or more on the PANSS conceptual disorganisation item
  • Received structured psychological intervention within the past 3 months
  • Relevant central nervous system or other medical disorders impacting participation
  • Diagnosis of intellectual disability
  • Unstable residential arrangements
  • Family members/carers with active DSM-5 substance use disorder
  • Family members/carers who received psychological intervention within the past 3 months
  • Family members/carers with unstable residential arrangements

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Civil hospital

Karachi, Sindh, Pakistan, 75600

Actively Recruiting

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Research Team

A

Ameer B Khoso

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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