Hanlon 2016.

Study name	Task sharing for the care of severe mental disorders in a low‐income country (TaSCS): study protocol for a randomised, controlled, non‐inferiority trial
Methods	Randomised controlled trial
Participants	Criteria Inclusion criteria for phase 1 1. 25 years of age and older 2. Participant in the ongoing Butajira, Ethiopia, 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 6 months and with a DSM‐IV (SCAN) diagnosis of schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder 3. Ongoing need for continuing mental health care due to a. Being on psychotropic medication at assessment or b. Not on medication but symptomatic at the time of assessment or c. Have experienced partial or full relapse within the 2 years preceding the assessment 4. Stable clinical condition: either in remission from SMD or with residual symptoms that have been stable over the preceding 3 months 5. Planning to stay resident in the area for 18 months 6. Able to communicate in Amharic, the official language of Ethiopia 7. Willing to be randomised to either of the service models as described in the protocol 8. Has capacity to consent to participation or permission given by guardian and not refusing to participate 9. Resident in catchment area of TaSCS health centres (excluding Butajira health centre) Exclusion criteria for phase 1 1. Suicide attempt within preceding 3 months 2. Current active suicide intent 3. Prescribed thioridazine, valproate, lithium, or second‐generation antipsychotic medications (risperidone and olanzapine), as these medications are not 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 4. Prescribed depot medication 5. Complex or unstable medical condition interfering with management of psychiatric disorder or requiring ongoing medical treatment from Butajira Hospital 6. Alcohol or khat dependence or abuse within the last 12 months 7. Pregnant or breast‐feeding 8. Restrained at home 9. 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 outpatient 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 outpatient clinic, the minimum age will be 25 years and participants should have had their first contact with specialist mental health services at least 2 years prior to recruitment into the trial to ensure comparability with the Butajira SMD cohort sample Exclusion criteria for phase 2 1. Current active suicide intent 2. Prescribed thioridazine, valproate, lithium or second‐generation antipsychotic medications (risperidone and olanzapine) 3. Pregnant or breast‐feeding and prescribed depot 4. Refusing to participate in the study 5. Medical condition requiring ongoing medical treatment from Butajira Hospital
Interventions	Intervention Integrated mental health in primary care A task‐shared model of collaborative mental health care integrated into the primary care setting. Participants in the intervention arm will receive a task‐sharing model of locally delivered mental health care integrated into primary health care. General health workers (health officers, nurses, and community‐based health extension workers) will be given brief training using the WHO mental health Gap Action Programme and ongoing supervision to deliver mental health care to people with severe mental disorders Control Psychiatric nurse‐led specialist care A centralised, psychiatric nurse‐led, hospital outpatient service with outreach from project outreach workers. Participants in the active control arm will receive an established model of centralised, specialist mental health care delivered by psychiatric nurses at an outpatient clinic within Butajira General Hospital and supported by outreach from project workers
Outcomes	Primary outcome Brief Psychiatric Rating Scale Secondary outcomes 1. WHODAS 2. Local functioning scale 3. Relapse of mental disorder (Life Chart Schedule) 4. Patient service satisfaction 5. Body mass index 6. Service utilisation (Client Service Receipt Inventory) 7. Medication side effects 8. Medication adherence 9. Stigma (Family Interview Schedule) 10. Restraint (proportion chained, restrained, or confined in the past month) 11. Adverse events 12. Quality of clinical care 13. Acceptance and feasibility
Starting date	March 2015
Contact information	Charlotte Hanlon, BM BS, PhD, Addis Ababa University and King's College London
Notes	Completed 16 November 2017, but not published yet ClinicalTrials.gov Identifier: NCT02308956