A cluster randomized controlled trial of a STEPped CARE intervention for depression in primary care

There is now considerable evidence in support of a stepped care approach to expanding mental health service. In this model, non-physician primary care providers deliver the bulk of essential mental health service under the supervision and support of physicians and of more highly trained mental health specialists. This process, commonly described as task-shifting, facilitates the delivery of needed care even in the context of extreme shortage of specialists as seen in most LMIC. The WHO recently produced a set of guidelines, the mhGAP Intervention Guide (mhGAP-IG), that incorporates evidence based interventions for a list of priority mental health conditions, including depression, to aid the recognition and management of such conditions in non-specialist settings. It builds on the well established knowledge that primary care providers can be trained to deliver both psychological and pharmacological interventions for several mental health conditions, while more highly trained providers, including specialists, offer necessary support and supervision and address more difficult conditions. The content of what constitutes essential ingredients to scale up mental health services is therefore generally agreed upon. However, the mode of delivery of the intervention in diverse settings still requires empirical exploration in order to determine the best fit to local health systems. Our study is designed to provide this evidence for Nigeria, the most populous nation in Africa, and also for most other countries in sub-Sahara Africa where the settings are similar. The proposed study sets out to assess the cost-effectiveness of a management program for depression delivered mainly by non-physician primary care providers in Nigeria in which supervision and support are provided by general doctors and specialists, wherever available, with the use of modern, affordable and readily available technology.

STEPCARE is a randomized controlled trial to test the effectiveness and cost-effectiveness of a program of intervention for depression delivered by non-physician primary care providers supported by general practitioners using mobile telephony. The trial will compare two arms: 1) an intervention arm in which a manualized intervention package is provided; and 2) a care as usual arm in which an enhanced usual care is delivered. Study will recruit adults with depression of at least moderate severity. Primary outcome, to be assessed at 6 months following recruitment, will be the proportion of cases who recover from depression.

STEPCARE offers the prospect of benefitting a broad range of persons and groups.
Depressed primary care users: Persons with depression rarely get evidence-based treatment in primary care.. Untreated or poorly treated depression is associated with poor medical and psychological outcomes as well as seriously affecting quality of life. STEPCARE is designed to make affordable and adequate intervention available to the large population of depressed primary care attendees. The knowledge to be gained in the study may translate to benefit not only to the persons recruited to the intervention arm of the study, but also, through its potential scaling up, to a much larger population of persons in need in low- and middle-income countries with similar profile of primary care service. Alleviating depression will redound to the benefit of the patients' immediate families and, ultimately, to the society at large through increased economic productivity and reduced unproductive health care use.
Primary care providers: The program will offer training for primary care providers on the recognition and treatment of depression, thus providing immediate benefit. The use of the manual will provide a structured way to procure physician support and supervision, thus increasing the morale of the providers and opening a line of continuous skills development. The manual to be developed should become a valuable clinical support tool that further enhances the ability of the providers to deliver good care within 1-2 years of study completion.
At the governmental level, a successful demonstration of the effectiveness and cost-effectiveness of the design we propose for treating persons with depression offers an important opportunity for scaling up service not only for depression but for several other disorders. The findings of STEPCARE will benefit the Nigerian National Primary Health Care Development Agency (NPHCDA) which is responsible for organizing and implementing programs of training for primary care providers as well as the Community Health Practitioners' Registration Board, the body that sets course standards, develops curriculum, and conducts the credentialing of primary care workers in Nigeria. The findings will offer the prospect of using similar approaches for scaling up service for other conditions in primary care and provide important information for the revision of the curricula of training of primary care providers in the country. Previous engagement with these agencies should facilitate the realization of this benefit within 2 - 3 years of completing the study.
The ongoing programme of health sector reform by the Federal Ministry of Health in which the central platform is the integration of mental health service into primary care will benefit from the findings of STEPCARE. Fortunately, the Mental Health Action Committee of the Ministry of Health which is playing a pivotal role in the reform as it relates to mental health service is chaired by the PI of STEPCARE, Professor Gureje, thus opening an important avenue for linking the findings of the research into policy. This benefit can be realized within 3 - 5 years after the findings of this work become known, given the process of getting this to policy agenda.
The World Health Organization will be interested in the findings of this project as it offers a realistic way for the mhGAP -IG to become a tool for supporting care delivery in settings where the bulk of the primary care providers are non-physicians. STEPCARE is an opportunity for empirical support to be provided for the utility of the tool, making it become available to a large group of potential users. The opportunity for facilitating the use of the findings will be provided in the continuing collaboration of Professor Gureje with the Organization in efforts relating to scaling up of mental health service in Nigeria and other low- and middle-income countries.