title: Task sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trial.
abstract: BACKGROUND
  Task sharing mental health care through integration into primary health care (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in low-income countries. However, the effectiveness, acceptability, feasibility and sustainability of this service model for people with a severe mental disorder (SMD) have not been evaluated in a low-income country.
  
  
  METHODS
  A randomised, controlled, non-inferiority trial will be carried out in a predominantly rural area of Ethiopia. A sample of 324 people with SMD (diagnoses of schizophrenia, schizoaffective disorder, bipolar disorder or major depressive disorder) with an ongoing need for mental health care will be recruited from 1) participants in a population-based cohort study and 2) people attending a psychiatric nurse-led out-patient clinic. The intervention is a task-sharing model of locally delivered mental health care for people with SMD integrated into PHC delivered over 18 months. Participants in the active control arm will receive the established and effective model of specialist mental health care delivered by psychiatric nurses at an out-patient clinic within a centrally located general hospital. The hypothesis is that people with SMD who receive mental health care integrated into PHC will have a non-inferior clinical outcome, defined as a mean symptom score on the Brief Psychiatric Rating Scale, expanded version, of no more than six points higher, compared to participants who receive the psychiatric nurse-led service, after 12 months. The primary outcome is change in symptom severity. Secondary outcomes are functional status, relapse, service use costs, service satisfaction, drop-out and medication adherence, nutritional status, physical health care, quality of care, medication side effects, stigma, adverse events and cost-effectiveness. Sustainability and cost-effectiveness will be further evaluated at 18 months. Randomisation will be stratified by health centre catchment area using random permuted blocks. The outcome assessors and investigators will be masked to allocation status.
  
  
  CONCLUSIONS
  Evidence about the effectiveness of task sharing mental health care for people with SMD in a rural, low-income African country will inform the World Health Organisation's mental health Gap Action Programme to scale-up mental health care globally.
  
  
  BACKGROUND
  NCT02308956 (ClinicalTrials.gov). Date of registration: 3 December 2014.
authors: Addis Ababa University, College of Health Sciences, School of Medicine, Department of Psychiatry, Addis Ababa, Ethiopia. charlotte.hanlon@kcl.ac.uk.|Institute of Psychiatry, Psychology and Neuroscience, Centre for Global Mental Health, King's College, London, UK. charlotte.hanlon@kcl.ac.uk.
authors: Charlotte
authors: C
authors: Hanlon
authors: Addis Ababa University, College of Health Sciences, School of Medicine, Department of Psychiatry, Addis Ababa, Ethiopia. atalay.alem@gmail.com.
authors: Atalay
authors: A
authors: Alem
authors: Aklilu Lemma Institute of Pathobiology, Addis Ababa University, Addis Ababa, Ethiopia. gtmedhin@yahoo.com.
authors: Girmay
authors: G
authors: Medhin
authors: Horizon Health Network, Dr Everett Chalmers Regional Hospital, Psychiatry, Fredericton, New Brunswick, Canada. teshome.kelkile@gmail.com.
authors: Teshome
authors: T
authors: Shibre
authors: Department of Pharmacology, St Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia. daejigu@gmail.com.
authors: Dawit A
authors: DA
authors: Ejigu
authors: Addis Ababa University, College of Health Sciences, School of Medicine, Department of Psychiatry, Addis Ababa, Ethiopia. movsic@yahoo.com.
authors: Hanna
authors: H
authors: Negussie
authors: Institute of Psychiatry, Psychology and Neuroscience, Centre for Global Mental Health, King's College, London, UK. michael.dewey@kcl.ac.uk.
authors: Michael
authors: M
authors: Dewey
authors: Department of Health, Behaviour and Society, Johns Hopkins School of Public Health, Baltimore, MD, USA. lwissow@jhmi.edu.
authors: Lawrence
authors: L
authors: Wissow
authors: Institute of Psychiatry, Psychology and Neuroscience, Centre for Global Mental Health, King's College, London, UK. martin.prince@kcl.ac.uk.
authors: Martin
authors: M
authors: Prince
authors: Mailman School of Public Health, Columbia University, New York, USA. ess8@cumc.columbia.edu.|New York State Psychiatric Institute, New York, USA. ess8@cumc.columbia.edu.
authors: Ezra
authors: E
authors: Susser
authors: Institute of Psychiatry, Psychology and Neuroscience, Centre for Global Mental Health, King's College, London, UK. crick.lund@uct.ac.za.|Department of Psychiatry and Mental Health, Alan J. Flisher Centre for Public Mental Health, University of Cape Town, 46 Sawkins Road, Rondebosch, Cape Town, South Africa. crick.lund@uct.ac.za.
authors: Crick
authors: C
authors: Lund
authors: Addis Ababa University, College of Health Sciences, School of Medicine, Department of Psychiatry, Addis Ababa, Ethiopia. abe.wassie@kcl.ac.uk.|Department of Psychological Medicine, Institute of Psychiatry, King's College London, Psychology and Neuroscience, Centre for Affective Disorders, London, UK. abe.wassie@kcl.ac.uk.
authors: Abebaw
authors: A
authors: Fekadu
mesh_terms: D006801:Humans; D002985:Clinical Protocols; D003627:Data Interpretation, Statistical; D005002:Ethiopia; D001523:Mental Disorders / Q000628:therapy; D008605:Mental Health Services; D017063:Outcome Assessment, Health Care; D011203:Poverty; D011320:Primary Health Care; D000074099:Equivalence Trials as Topic