We propose to conduct two complementary randomized controlled trials (RCTs) of task shifting to primary health care (PHC), one in Ethiopia on the care of severe mental disorders (SMDs) (n=690), and one in South Africa (SA) on the care of maternal depression (n=380). In two complementary sets of disorders (SMD and maternal depression) and two country contexts (Ethiopia and South Africa) our specific alms are: 1. To determine the effectiveness and cost-effectiveness of task shifting care to PHC, compared to specialist mental health care in Ethiopia and enhanced usual care in SA, on both primary outcome measures(of effectiveness and cost-effectiveness) and on a series of secondary outcome measures. 2. To examine factors influencing the implementation of the task shifting intervention and future scale up, by assessing feasibility, sustainability, quality, and safety, and by qualitative exploration of the experience of task shifting from the perspectives of both PHC workers and patients. 3. To evaluate locally relevant but generalizable measures, including both symptom severity measures and functioning/quality of life measures, for evaluating the effectiveness and cost-effectiveness of task shifting care to PHC In Ethiopia, the intervention will be task shifting of care of stabilised persons with SMD to PHC, through 2 weeks of training and ongoing supervision by a psychiatric nurse, and refresher training. In South Africa, PHC staff will be trained (1 week of training with ongoing weekly supervision from the mental health specialist and emergency consultation) to routinely screen women attending antenatal clinics for maternal depression using the Edinburgh Postnatal Depression Scale. Community health workers (CHWs) servicing the area will also be trained to deliver the adapted IPT intervention under the supervision of the mental health specialist. Primary outcome measures will be symptom severity, measured on the Brief Psychiatric Rating Scale in Ethiopia at 12 months, and the Hamilton Depression Scale in SA at 6 months postnatal. Both of the trials will also calculate cost per Disability Adjusted Life, and include a qualitative component.
Centralized services and critical shortages of specialist mental health workers are the main causes of the large treatment gap for mental disorders In sub-Saharan Africa. The proposed trials will be the first RCTs evaluating task-shifting models of delivering care for persons with SMD and maternal depression in sub-Saharan Africa. Evidence from these trials will have major implications for other LMICs in sub-Saharan Africa which face similar challenges of limited specialist mental health workers and rapidly urbanizing populations.
|De Silva, Mary J; Breuer, Erica; Lee, Lucy et al. (2014) Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions. Trials 15:267|