CognIFied: protocol for a pilot randomised controlled trial of a culturally adapted, task-shifted compensatory cognitive training intervention for young adults with first-episode psychosis in Nigeria

TL;DR

This study tests a culturally adapted cognitive training program for young adults with first-episode psychosis in Nigeria to improve cognitive function and reduce disability.

Contribution

The study introduces a culturally adapted, task-shifted compensatory cognitive training intervention for psychosis in a low-income country context.

Findings

CognIFied will assess feasibility and acceptability of a new cognitive training approach in Nigeria.

The study will evaluate cognitive and functional outcomes over 12 months in young adults with psychosis.

Qualitative and economic evaluations will inform implementation strategies and cost-effectiveness.

Abstract

Cognitive impairment is present in the majority of individuals with first-episode psychosis (FEP) and is a strong predictor of long-term functional disability. Despite this, evidence-based cognitive interventions are rarely available in routine mental healthcare in low-income and middle-income countries, where most young people with psychosis reside. This protocol describes the CognIFied study, a pilot randomised controlled trial evaluating the feasibility and acceptability of a culturally adapted, task-shifted compensatory cognitive training (CCT) intervention for young adults with FEP in Nigeria.

CognIFied is a multicentre, assessor-blind, parallel-group pilot randomised controlled trial with an embedded mixed-methods process evaluation. The study will recruit 180 young adults aged 18–30 years with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)-defined FEP (onset within the past 5 years) and objective cognitive impairment from three public psychiatric hospitals in Nigeria. Participants will be randomised 1:1 to receive either culturally adapted CCT or an active control condition, Enhanced Recreational Therapy. Both interventions comprise 12 weekly group sessions lasting 60–90 min. CCT is delivered by trained psychiatric social workers using a manualised curriculum co-designed with young people with lived experience. Primary outcomes assess feasibility (recruitment, retention, intervention adherence), acceptability (Client Satisfaction Questionnaire-8) and intervention fidelity. Secondary outcomes include preliminary signals of effectiveness on global cognitive functioning (Brief Assessment of Cognition in Schizophrenia) and functional capacity (University of California, San Diego [UCSD] Performance-Based Skills Assessment), assessed at baseline and at 3, 6 and 12 months. Quantitative analyses will be descriptive and exploratory, supplemented by qualitative inquiry guided by Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) and Consolidated Framework for Implementation Research frameworks and an exploratory economic evaluation.

Ethical approval has been obtained from relevant institutional review boards. Findings will be disseminated through open-access publications, policy-focused stakeholder engagement and community dissemination co-led by a Youth Research Team.

ISRCTN44794154.

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