Community-based Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE): study protocol for a cluster randomised controlled trial

Abstract

BackgroundCare for most people with schizophrenia is best delivered in the community and evidence-based guidelines recommend combining both medication and a psychosocial intervention, such as community-based rehabilitation. There is emerging evidence that community-based rehabilitation for schizophrenia is effective at reducing disability in middle-income country settings, yet there is no published evidence on the effectiveness in settings with fewer mental health resources. This paper describes the protocol of a study that aims to evaluate the effectiveness of community-based rehabilitation as an adjunct to health facility-based care in rural Ethiopia.MethodsThis is a cluster randomised trial set in a rural district in Ethiopia, with sub-district as the unit of randomisation. Participants will be recruited from an existing cohort of people with schizophrenia receiving treatment in primary care. Fifty-four sub-districts will be randomly allocated in a 1:1 ratio to facility-based care plus community-based rehabilitation (intervention arm) or facility-based care alone (control arm). Facility-based care consists of treatment by a nurse or health officer in primary care (antipsychotic medication, basic psychoeducation and follow-up) with referral to a psychiatric nurse-led outpatient clinic or psychiatric hospital when required. Trained community-based rehabilitation workers will deliver a manualised community-based rehabilitation intervention, with regular individual and group supervision. We aim to recruit 182 people with schizophrenia and their caregivers. Potential participants will be screened for eligibility, including enduring or disabling illness. Participants will be recruited after providing informed consent or, for participants without decision-making capacity, after the primary caregiver gives permission on behalf of the participant. The primary outcome is disability measured with the 36-item WHO Disability Assessment Schedule (WHODAS) version 2.0 at 12 months. The sample size will allow us to detect a 20 % difference in WHODAS 2.0 scores between treatment arms with 85 % power. Secondary outcomes include change in symptom severity, economic activity, physical restraint, discrimination and caregiver burden.DiscussionThis is the first trial of community-based rehabilitation for schizophrenia and will determine, as a proof of concept, the added value of community-based rehabilitation compared to facility-based care alone in a low-income country with scarce mental health resources.Trial registrationClinical Trials.gov Identifier NCT02160249. Registered on 3 June 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1427-9) contains supplementary material, which is available to authorized users.

Food insecurity among people with severe mental disorder in a rural Ethiopian setting: a comparative, population-based study

“…Our findings suggest that interventions to address food insecurity need to include both expanded access to mental health care (to reduce disability) and strategies to alleviate poverty, particularly for vulnerable individuals living with SMD. Through the PRIME project, and in keeping with the policy of the Federal Ministry of Health of Ethiopia, access to mental health care is being increased through integration into PHC in this district (Fekadu et al, 2016).…”

“…People with probable SMD were identified by community-based health extension workers, community leaders and project outreach workers who had received half a day of training on common presentations of SMD for the setting (Fekadu et al, 2016). This key informant method has been shown to be an effective means of community ascertainment of SMD for this setting (Shibre et al, 2002).…”

Challenges and Opportunities in Global Mental Health: a Research-to-Practice Perspective

“…Still, while the effectiveness of interventions for schizophrenia in LMICs is evident, implementation research is needed on how interventions can be integrated into existing services, including attention to human resource constraints and insurance coverage [49•]. For example, Asher et al (e.g., [50]) piloted an intervention for community-based rehabilitation in Ethiopia, and a collaborative study in Brazil and Chile is now examining the implementation of the Critical Time Intervention delivered by lay health workers [51]. Additional research on early intervention for schizophrenia in LMICs is needed [52], and, similar to research addressing common mental disorders, greater efforts are necessary to link research with policy-making such that EBPs are adopted and scaled up.…”

The World Health Organization Disability Assessment Schedule 2 (WHODAS 2.0): remarks on the need to revise the WHODAS

“…Several papers with clinical approach can also be found. Reports of researches on evaluating mental functions in individuals with Huntington disease 39 ; on assessing disability in men referred for treatment with work-related primary mental health care problems 40 ; on researching the effect of a community-based rehabilitation intervention for people with schizophrenia 41 ; on investigating disability in patients undergoing neurosurgical procedures 42 ; on the knee posture during gait and global functioning post-stroke 43 ; could be examples.…”