Status:
COMPLETED
Task Sharing for the Care of Severe Mental Disorders in a Low-income Country
Lead Sponsor:
University of Cape Town
Collaborating Sponsors:
Addis Ababa University
King's College London
Conditions:
Schizophrenia
Bipolar Disorder
Eligibility:
All Genders
25+ years
Phase:
PHASE3
Brief Summary
Task sharing mental health care through integration of mental health into primary health care (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in low-income countries....
Detailed Description
Background and rationale Task sharing mental health care through integration of mental health into primary health care (PHC) is advocated as a means of narrowing the treatment gap for mental disorders...
Eligibility Criteria
Inclusion
- Inclusion criteria for phase 1
- Participant in the ongoing Butajira SMD cohort study (at baseline (between 1998 and 2001), cohort participants were aged between 15 and 49 years, resident in the area for at least six months and had a DSM-IV (SCAN) diagnosis of schizophrenia or schizoaffective disorder, bipolar disorder or major depressive disorder)
- Ongoing need for continuing mental health care due to:
- being on psychotropic medication at assessment or,
- not on medication but symptomatic at the time of assessment, or
- have experienced partial or full relapse within the two years preceding the assessment
- Stable clinical condition: either in remission from SMD or with residual symptoms that have been stable over the preceding three months.
- Planning to stay resident in the area for 18 months.
- Able to communicate in Amharic, the official language of Ethiopia.
- Willing to be randomised to either of the service models as described in the protocol.
- Has capacity to consent to participation or permission given by guardian and not refusing to participate
- Resident in catchment area of TaSCS health centres (excluding Butajira health centre)
- Exclusion criteria for phase 1
- Suicide attempt within the preceding three months
- Current active suicide intent
- Prescribed Thioridazine, Valproate, Lithium or second generation antipsychotic medications (Risperidone and Olanzapine), as these medications are not be available in psychiatric nurse-led units or PHC settings in Ethiopia. Within the Butajira SMD cohort, only people who have received care from psychiatrist-led units in the capital city, Addis Ababa, might be receiving these medications. At present, fewer than 10 patients are known to be taking one of these medications.
- Prescribed depot medication
- Complex or unstable medical condition interfering with management of psychiatric disorder or requiring ongoing medical treatment from Butajira hospital
- Alcohol or khat dependence or abuse within the last 12 months
- Pregnant or breast-feeding
- Restrained at home
- Refusing to participate in the study
- Inclusion criteria for Phase 2 As for Phase 1, but if we are unable to recruit enough participants from the existing Butajira SMD cohort then we will expand recruitment to people with SMD attending the psychiatric out-patient clinic at Butajira hospital. A semi-structured diagnostic interview will be carried out to determine diagnostic eligibility (DSM-IV diagnosis of schizophrenia or schizoaffective disorder, bipolar disorder or major depressive disorder). For participants recruited from Butajira hospital psychiatric out-patient clinic, the minimum age will be 25 years and the participants should have had their first contact with specialist mental health services at least two years prior to recruitment into the trial to ensure comparability with the Butajira SMD cohort sample.
- Exclusion criteria for Phase 2
- Current active suicide intent
- Prescribed Thioridazine, Valproate, Lithium or second generation antipsychotic medications (Risperidone and Olanzapine).
- Pregnant or breast-feeding and prescribed depot
- Refusing to participate in the study
- Medical condition requiring ongoing medical treatment from Butajira hospital
Exclusion
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2017
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT02308956
Start Date
March 1 2015
End Date
November 16 2017
Last Update
November 29 2017
Active Locations (1)
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1
Butajira mental health research office
Butajīra, Ethiopia