Abstract
BackgroundTask sharing mental health care through integration into primary health care (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in low-income countries. However, the effectiveness, acceptability, feasibility and sustainability of this service model for people with a severe mental disorder (SMD) have not been evaluated in a low-income country.Methods/DesignA randomised, controlled, non-inferiority trial will be carried out in a predominantly rural area of Ethiopia. A sample of 324 people with SMD (diagnoses of schizophrenia, schizoaffective disorder, bipolar disorder or major depressive disorder) with an ongoing need for mental health care will be recruited from 1) participants in a population-based cohort study and 2) people attending a psychiatric nurse-led out-patient clinic. The intervention is a task-sharing model of locally delivered mental health care for people with SMD integrated into PHC delivered over 18 months. Participants in the active control arm will receive the established and effective model of specialist mental health care delivered by psychiatric nurses at an out-patient clinic within a centrally located general hospital. The hypothesis is that people with SMD who receive mental health care integrated into PHC will have a non-inferior clinical outcome, defined as a mean symptom score on the Brief Psychiatric Rating Scale, expanded version, of no more than six points higher, compared to participants who receive the psychiatric nurse-led service, after 12 months. The primary outcome is change in symptom severity. Secondary outcomes are functional status, relapse, service use costs, service satisfaction, drop-out and medication adherence, nutritional status, physical health care, quality of care, medication side effects, stigma, adverse events and cost-effectiveness. Sustainability and cost-effectiveness will be further evaluated at 18 months. Randomisation will be stratified by health centre catchment area using random permuted blocks. The outcome assessors and investigators will be masked to allocation status.DiscussionEvidence about the effectiveness of task sharing mental health care for people with SMD in a rural, low-income African country will inform the World Health Organisation’s mental health Gap Action Programme to scale-up mental health care globally.Trial registrationNCT02308956 (ClinicalTrials.gov). Date of registration: 3 December 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1191-x) contains supplementary material, which is available to authorized users.
Highlights
Task sharing mental health care through integration into primary health care (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in low-income countries
Rationale for a non-inferiority trial In this trial, we propose to investigate the non-inferiority of a task-sharing model of mental health care in PHC compared to the established alternative service model within Ethiopia: a less accessible, but more specialist, psychiatric nurse-led model of care
A pressing need exists to scale up evidence-based packages of mental health care in LMICs and thereby improve the clinical, functional and social outcomes of people with mental disorders
Summary
Task sharing mental health care through integration into primary health care (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in low-income countries. Task-sharing care to alleviate the burden of severe mental disorders in Africa The unmet need for mental health care is high in all countries of the world but is acute in low-income countries [1]. Ethiopia is typical of most low-income countries, with fewer than 10 % of people with severe mental disorders (SMD) receiving mental health care [2]. Centralised services, a critical shortage of specialist mental health workers and an absence of mental health care in general health care settings are the main causes of this large treatment gap for SMDs in the low-income countries of sub-Saharan Africa [15]. It is advocated that primary care and general health care workers be given brief training to deliver circumscribed aspects of care for prioritised mental, neurological and substance-use disorders, with the support of specialist mental health workers who provide supervision, consultation, refresher training and referral [21]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
