Culturally Adapted Psychosocial Interventions (CaPSI) for Early Psychosis in Low-Resource Settings: Study Protocol for a Multi-Center Randomized Controlled Trial (RCT)

Overview

This study explores the effectiveness of culturally adapted Cognitive Behavioural Therapy (CaCBT) and Family Intervention (CulFI) for individuals with first-episode psychosis (FEP) in Pakistan. With a focus on low-resource settings, the trial aims to determine if these culturally adapted therapies improve outcomes over the standard treatment as usual (TAU).

Background

Psychosis is a significant cause of disability worldwide, especially in low- and middle-income countries (LMICs), where resources are limited. While Cognitive Behavioural Therapy (CBT) and Family Intervention (FI) are recommended globally for psychosis, there is little evidence supporting their use in LMICs. This study addresses the need for culturally adapted interventions for FEP, an early stage of psychosis, in Pakistan.

Objectives

The study has six primary objectives:

  1. Assess the clinical effectiveness of CaCBT and CulFI in reducing psychosis symptoms.
  2. Evaluate their impact on positive and negative symptoms, quality of life, and general functioning.
  3. Measure improvements in carer experiences and mental health.
  4. Compare the efficacy of CaCBT and CulFI in achieving patient and carer-related outcomes.
  5. Conduct a cost-effectiveness analysis for implementing these interventions.
  6. Identify facilitators and barriers to the adoption of these interventions through process evaluation.

Methods

The trial is a three-arm RCT with 390 participants recruited across ten major centers in Pakistan. Participants are randomly assigned to CaCBT, CulFI, or TAU. Assessments are conducted at baseline, three, six, and twelve months post-intervention.

Interventions

– CaCBT: Tailored CBT sessions focusing on psychosis-specific symptoms, delivered over 12 weeks by trained psychologists, integrating cultural aspects like religious teachings.

– CulFI: Family-focused therapy sessions involving the patient and family members, covering psychoeducation, stress management, crisis intervention, and relapse prevention.

– TAU (Control: Standard antipsychotic medication without additional psychosocial support.

Outcome Measures

The primary outcome is the reduction in psychosis symptoms, measured by the Positive and Negative Syndrome Scale (PANSS). Secondary measures include quality of life, general psychopathology, and carer wellbeing.

Statistical Analysis

The study will use linear mixed-effects models to assess treatment effects. Both endpoint and longitudinal analyses will be conducted to understand the interventions’ short- and long-term effects.

Ethical Considerations

Ethical approval was obtained from the National Bioethics Committee of Pakistan and the Centre for Addiction and Mental Health in Toronto, Canada. All participants provide informed consent, and privacy is strictly maintained.

Significance

This study could pave the way for scalable, culturally sensitive interventions in LMICs, improving clinical and social outcomes for individuals with psychosis in Pakistan and similar settings.