COllaborative Shared care to IMprove Psychosis Outcome (COSIMPO): study protocol for a randomized controlled trial.

Journal: Trials

Volume: 18

Issue: 1

Year of Publication: 2018

Affiliated Institutions:  Department of Psychiatry, University of Ibadan, Ibadan, Nigeria. ogureje@com.ui.edu.ng. Department of Psychiatry, University of Ibadan, Ibadan, Nigeria. World Health Organization Collaborating Centre, Department of Psychiatry, University of Ibadan, Ibadan, Nigeria. Department of Epidemiology, Medical Statistics and Environmental Health, University of Ibadan, Ibadan, Nigeria. National Institute of Mental Health, Bethesda, MD, USA. Kwame Nkrumah University of Science and Technology, Kumasi, Ghana. University of Liberia, Monrovia, Liberia. University of Nairobi, Nairobi, Kenya. Stellenbosch University, Stellenbosch Central, Stellenbosch, South Africa.

Abstract summary 

Psychotic disorders are a group of severe mental disorders that cause considerable disability to sufferers and a high level of burden to families. In many low- and middle-income countries (LMIC), traditional and faith healers are the main providers of care to affected persons. Even though frequently canvassed as desirable for improved care delivery, collaboration between these complementary alternative health providers (CAPs) and conventional health providers has yet to be rigorously tested for feasibility and effectiveness on patient outcomes.COSIMPO is a single-blind, cluster randomized controlled trial (RCT) being conducted in Nigeria and Ghana to compare the effectiveness of a collaborative shared care (CSC) intervention program implemented by CAPs and primary health care providers (PHCPs) with care as usual (CAU) at improving the outcome of patients with psychosis. The study is designed to test the hypotheses that patients receiving CSC will have a better clinical outcome and experience fewer harmful treatment practices from the CAPs than patients receiving CAU at 6 months after study entry. An estimated sample of 296 participants will be recruited from across 51 clusters, with a cluster consisting of a primary care clinic and its neighboring CAP facilities. CSC is a manualized intervention package consisting of regular and scheduled visits of PHCPs to CAP facilities to assist with the management of trial participants. Assistance includes the administration of antipsychotic medications, management of comorbid physical condition, assisting the CAP to avoid harmful treatment practices, and engaging with CAPs, caregivers and participants in planning discharge and rehabilitation. The primary outcome, assessed at 6 months following trial entry, is improvement on the Positive and Negative Symptom Scale (PANSS). Secondary outcomes, assessed at 3 and 6 months, consist of levels of disability, experience of harmful treatment practices and of victimization, and levels of perceived stigma and of caregivers' burden.Information about whether collaboration between orthodox and complementary health providers is feasible and can lead to improved outcome for patients is important to formulating policies designed to formally engage the services of traditional and faith healers within the public health system.National Institutes of Health Clinical Trial registry, ID: NCT02895269 . Registered on 30 July 2016.

Authors & Co-authors:  Gureje Makanjuola Kola Yusuf Price Esan Oladeji Appiah-Poku Haris Othieno Seedat

Study Outcome 

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Statistics
Citations :  Murray C, Vos T, Lozano R, Naghavi M, Flaxman A, Michaud C, Ezzati M, Shibuya K, Salomon J, Abdalla S, et al. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990–2010: a systematic analysis for the Global Burden of Disease Study. Lancet. 2010;2012:2197–223.
Authors :  11
Identifiers
Doi : 462
SSN : 1745-6215
Study Population
Male,Female
Mesh Terms
Antipsychotic Agents
Other Terms
Collaboration;Complementary alternative providers;Primary care;psychosis
Study Design
Study Approach
Country of Study
Niger
Publication Country
England