A cluster randomized clinical trial of a stepped care intervention for depression in primary care (STEPCARE)- study protocol

Gureje et al. BMC Psychiatry (2015) 15:148 DOI 10.1186/s12888-015-0542-6 STUDY PROTOCOL Open Access A cluster randomized clinical trial of a stepped care intervention for depression in primary care (STEPCARE)- study protocol Oye Gureje1*, Bibilola Damilola Oladeji1, Ricardo Araya2 and Alan A. Montgomery3 Abstract Background: Depression constitutes a significant public health burden and is associated is with high level of individual suffering. Insufficient human and material resources impede the provision of adequate care for persons with the condition in low- and middle-income countries. It is commonly recognized that, to bridge this treatment gap, it is essential to integrate the treatment of depression into primary health care system. Methods/Design: STEPCARE is a two-arm parallel cluster randomized controlled trial to compare a stepped-care intervention package for depression in primary health care with care as usual in Nigeria. Randomization was conducted at the level of the participating primary health care clinics, while interventions are delivered to consenting individual participants who screen positive on the 9-item patient health questionnaire (PHQ-9 score ≥ 11) and fulfil the DSM-IV criteria for major depression. Intervention delivered by trained primary health care workers (PHCW) supported by general physicians and psychiatrists as needed is in 3 steps determined by response to treatment. Each step consists of psychological interventions (including psychoeducation, activity scheduling, social network reactivation and problem solving treatment) offered to all participants and, depending on severity and response, medication. Primary outcome, assessed at 12 months following recruitment into the trial, is recovery from depression as shown by a PHQ-9 score of less than 6. Secondary outcomes include changes in disability, quality of life and service utilization assessed at 6 and 12 months. Discussion: The stepped care model examines the effectiveness of an intervention package for depression in which the intensity of treatment is determined by the clinical need of the patients. This approach is designed to make the most efficient use of available resources. Trial registration: ISRCTN46754188 (ISRTCN registry at isrtcn.com; registered 23 September 2013) Keywords: Depression, Primary health care, Stepped care Background It is estimated that depressive disorders will become the third most burdensome health problem in low income countries after HIV/AIDS and perinatal conditions by 2030 [1]. In Nigeria, the 12-month prevalence rates of depression in the general population is within a range of 1.5-7 % [2]. Studies in primary care show that depression is a common problem, occurring in up to 10-20 % of clinic attendees [3, 4]. Depression is strongly associated * Correspondence: 1 Department of Psychiatry, College of Medicine, University of Ibadan, Ibadan, Nigeria Full list of author information is available at the end of the article with poverty and social disadvantage [5] and is a risk factor for suicide, majority of which occurs in low and middle income countries (LMIC) [6]. Even though effective treatments for depression are available which, if provided, could alleviate the negative consequences of depression, a previous study in Nigeria showed that about four out of five persons with severe mental disorders, particularly depression, had received no treatment in the previous year and that, among those who did, only about 10 % received what could be considered as minimally adequate treatment [7, 8]. The Nigerian health system, similar to that in most of sub-Saharan Africa, is characterized by extreme resource © 2015 Gureje et al. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http:// creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Gureje et al. BMC Psychiatry (2015) 15:148 constraints, both human and material. For example, there is only about one psychiatrist to a population of one million people and the few available specialists are inequitably concentrated in urban settings [9]. It is generally recognized that a way to minimize the consequences of this specialist manpower constraint is to integrate mental health (MH) into primary health care where services are mostly provided by non-physician primary health care workers (PHCWs). This strategy is much more likely to be viable and affordable because these resources already exist, are less expensive, and offer increased accessibility given that primary care clinics are closer to where people live. However this strategy is hampered by several factors: 1) inadequate training of the PHCWs, 2) lack of structured support and supervision for their work, and 3) competing duties [10]. The problem of lack of resources is further compounded by the inefficiency with which the limited available resources are used. For example, treatments lacking any evidence are often offered and specialist time and skill are not efficiently deployed. A new model to address the treatment gap for depression must therefore give prominence to a more efficient way of deploying existing resources to deliver effective interventions. Stepped-care models seek to maximize efficiency by deploying available resources strictly according to needs, offering greater resources to those with complex or severe problems [11]. There is now considerable evidence in support of stepped and collaborative care approaches to expanding mental health service [12, 13]. In this model, nonphysician PHCWs deliver the bulk of essential mental health service under the supervision and support of nurses or physicians and occasionally of more highly trained mental health specialists, where these are available. This process, best described as task-sharing, facilitates the delivery of evidence-based health care even in the context of extreme shortage of specialists as seen in most LMIC. The World Health Organization (WHO) has produced a set of guidelines, the mental health gap action programme intervention guide (mhGAP-IG), that incorporates evidence-based interventions for a list of priority mental health conditions, including depression, to aid the management of these conditions in nonspecialist settings [14]. 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 specialists offer necessary supervision and/or address more difficult or complex problems. The content of what is needed to scale up mental health services is therefore generally agreed upon. However, the mode of delivery of t (...truncated)