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

Abstract

BackgroundPsychotic 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.Methods/designCOSIMPO 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.DiscussionInformation 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.Trial registrationNational Institutes of Health Clinical Trial registry, ID: NCT02895269. Registered on 30 July 2016Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2187-x) contains supplementary material, which is available to authorized users.

Partnership for mental health development in Sub-Saharan Africa (PaM-D): a collaborative initiative for research and capacity building

“…In the second phase of the research component, a fully powered RCT of the collaborative intervention was implemented. The COllaborative Shared care to IMprove Psychosis Outcome (COSIMPO) is a single-blind cluster RCT being conducted in Nigeria and Ghana to compare the effectiveness of a CSC intervention program implemented by CAPs and PHCPs with care as usual (CAU) at improving the outcome of patients with psychosis (Gureje et al ., 2017). The CSC is based on a manualised intervention package, as previously described and consists of scheduled visits as well as response to unscheduled requests by the PHCPs to CAP facilities to assist with the management of trial participants.…”

“…Second, the research component had the inherent challenge of taking consent from persons with a severe mental disorder (psychosis) and of explaining to patients that they may be randomised to receive care that was judged by researchers not to be the gold standard. These were addressed through careful attention to them in the study protocols (Gureje et al ., 2017) as well as well-planned training in partnership building by those involved in the field work. For example, several informal meetings were organised between PHCPs and T&FHs during training and debriefing activities to encourage rapport building and mutual trust.…”

“…The PHCPs follow the specifications of the mhGAP-IG in offering treatment and initiating referral whenever indicated. The methods are described in full elsewhere (Gureje et al ., 2017).…”

Next steps for meeting the needs of people with severe mental illness in low- and middle-income countries

“…Engagement with traditional and faith healers is often recommended as an essential part of community provision of care for people with SMI, but this is rarely put into practice and even more rarely evaluated (Nortje et al 2016). In the COllaborative Shared care to IMprove Psychosis Outcome (COSIMPO) trial in Nigeria and Ghana, people with SMI will be allocated randomly to a collaborative care model between alternative care providers (Christian faith healers, Islamic faith healers and traditional healers) and primary health care providers or enhanced care as usual (Gureje, 2016). Impact will measure the experience of abusive practices as well as symptom reduction.…”

“…Underpinning efforts to improve the evidence base of care for people with SMI is the need for mental health professionals in LMICs to be trained in a public mental health perspective, with awareness of the need to expand mental health care and interest in identifying contextually appropriate and effective service approaches to achieving this goal. Efforts to build capacity to generate locally applicable evidence have been instrumental in many of the initiatives described in this paper (Lund et al 2012; Minoletti et al 2012; Gureje, 2016; Hanlon et al 2016).…”