Partnership for Mental Health Development in Sub-Saharan Africa: COllaborative Shared Care to IMprove Psychosis Outcome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Ibadan
- Enrollment
- 307
- Locations
- 2
- Primary Endpoint
- Reduction in symptoms of psychosis
Study Overview
Brief Summary
COSIMPO is a randomised controlled trial in which a collaborative shared care for psychosis implemented by complementary alternative providers (traditional and faith healers) and conventional primary health care providers (PHCP) is compared with care as usual in which no formal collaboration takes place between the two groups of health providers. COSIMPO is therefore a test of a complex task sharing approach for the care of patients with severe mental disorders.
Detailed Description
Most patients with psychotic disorders receive care from traditional and faith healers (complementary alternative providers, CAPs) in the setting of COSIMPO (Nigeria, Ghana). Treatment modalities by the healers include the use of herbs and rituals but may also involve potentially harmful practices such as shackling and scarification. The objective of COSIMPO is to compare the effectiveness of a collaborative shared care program between the CAPs and PHCP in improving the outcome of patients with psychosis under the care of CAPs facilities compared with that of usual care. A cluster randomized control trial design is implemented in Nigeria and Ghana. Patients in the control arm receives usual care enhanced through the training of PHCP in the arm, but no structured or formal collaboration is implemented.
Primary hypothesis: Patients presenting to CAPs facilities engaged in collaborative shared care with PHCP will have better outcome of psychosis compared to patients in enhanced usual care at 6 months following entry into the trial as measured by a significant mean reduction in symptoms as rated with the Positive and Negative Syndrome scale (PANSS). For the purpose of this study, a 7-point difference on the PANSS total outcome scores between the two groups will be regarded as a clinically meaningful difference.
Secondary hypotheses:
- Persons with psychosis receiving treatment from CAPs in the collaborative care program will be less likely to receive harmful treatment or be subject to human rights abuses (such as chaining, beating, starving, scarification, isolation, forced and prolonged fasting) than those receiving care as usual.
- Persons in the intervention arm will be less likely to experience victimization and abuse from caregivers. Victimisation is defined as an act or action that exploits or treats a patient unfairly.
- The patients in the intervention arm will have significantly less disability than those in the control arm
- The providers (both CAPs and PHCPs) in the collaborative care program will have better attitudes to and knowledge of psychosis than those in the (enhanced) care as usual.
- Collaborative share care will be more cost effective than usual care. Setting and location of RCT Nigeria: The study site in Nigeria is Ibadan, one of the largest cities in Africa. The inhabitants are mostly Yoruba with a mix of religious practices being prevalent. Ibadan is a cosmopolitan city with five of its eleven local governments (districts) being urban while the remaining six are rural or semi-urban. The population of Ibadan as of the last census in 2006 was 1,338,659, (Census 2006). There are on the average about 10 PHCs in each of the local governments and traditional health practice facilities are ubiquitous. All eleven local government areas in and around Ibadan are included in the study
Ghana: The Ashanti Region is located in south Ghana and third largest of 10 administrative regions. With a population of 3,612,950, the region accounts for 19.1 percent of Ghana's total population (2010 census) (Awuah-Nyamekye, Samuel, and Paul Sarfo-Mensah, 2012). Seven districts were selected for the study in Ashanti on the basis of having the size of population required for the study and being accessible to the research center.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 18 and over and who speak the study language of Yoruba (Nigeria) or Kwi (Ghana). Only patients who speak the languages of the study will be included.
- •All patients presenting to the CAPs in the selected clusters with a confirmed diagnosis of non-organic psychosis as assessed by research interviewers using the Structured Clinical Interview for DSM (SCID).
- •Patients must be on admission at the CAP facility and must be symptomatic at the time of recruitment as indicated by a minimum total PANSS score of
- •Patients must have a caregiver who is willing to give consent to participate in the study.
Exclusion Criteria
- •Those with serious physical illness in need of urgent medical attention (this could be a serious infection, injury, etc.).
- •Serious cognitive impairment that may interfere with assessment by the research team.
- •Those who will not be in the study area for at least six month following recruitment.
- •Women who are pregnant or will attempt to become pregnant during the study period.
Outcomes
Primary Outcomes
Reduction in symptoms of psychosis
Time Frame: 6 months
The primary outcome will be improvement of psychosis as determined by a 7-point difference on the PANSS total scores between the two groups at 6 months after study entry, controlling for baseline scores.
Secondary Outcomes
- Disability(3, and 6 months)
- Stigma(3,and 6 months)
- Victimisation(3, and 6 months)
- Harmful treatment practices(3,and 6 months)
Investigators
Prof Oye Gureje
Professor of Psychiatry
University of Ibadan