NCT05814913: CaPSI

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

Recruiting now NA Last updated 12 December 2024

What this trial tests

NA trial testing CaCBT for psychosis in Psychosis in 390 participants. Currently enrolling.

Timeline

15 April 2024

Primary endpoint
30 June 2026

31 December 2026

Quick facts

Lead sponsor	Pakistan Institute of Living and Learning
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	390
Start date	15 April 2024
Primary completion	30 June 2026
Estimated completion	31 December 2026
Sites	1 location across Pakistan

Drugs / interventions tested

• CaCBT for psychosis
• Culturally adapted Family Intervention (CulFI) for psychosis

Conditions studied

• Psychosis — all drugs for Psychosis →

Sponsor

Pakistan Institute of Living and Learning

Who can join

18 and older, any sex, with Psychosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Family-based interventions versus standard care for people with schizophrenia.
   Chien WT, Ma DCF, Bressington D, Mou H. · · 2024 · cited 13× · PMID 39364773 · DOI 10.1002/14651858.cd013541.pub2
2. Culturally adapted psychosocial interventions (CaPSI) for early psychosis in a low-resource setting: study protocol for a large multi-center RCT.
   Husain MO, Khoso AB, Kiran T, Chaudhry N, et al · · 2023 · cited 1× · PMID 37328751 · DOI 10.1186/s12888-023-04904-8