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

NCT05814913 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2024-12-12

No results posted yet for this study

Summary

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

Interventions

BEHAVIORAL

CaCBT for psychosis

The CaCBT intervention is based on the intervention manual developed by David Kingdon and Douglas Turkington, and culturally adapted by our group. CaCBT aims to take a collaborative approach to gaining an understanding of the symptoms

BEHAVIORAL

Culturally adapted Family Intervention (CulFI) for psychosis

CulFI intervention comprises of Family psychoeducation; cognitive-behavioural skills training for stress-management, coping and problem solving; crisis intervention and suicide risk management; relapse prevention; education and support regarding the family environment, including communication training. The components are designed to facilitate an understanding about psychosis, the emotional impact of the illness on family relationships, to promote more adaptive coping strategies and minimize relapse risk.

Sponsors & Collaborators

  • Centre for Addiction and Mental Health

    collaborator OTHER

  • Pakistan Institute of Living and Learning

    lead OTHER

Principal Investigators

  • Omair Husain, MD · Centre for Addiction and Mental Health

  • Imran B Chaudhry, MD · Pakistan Institute of Living and Learning

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05814913 on ClinicalTrials.gov