A pilot randomized controlled trial of a stepped care intervention package for depression in primary care in Nigeria

Oladeji et al. BMC Psychiatry (2015) 15:96 DOI 10.1186/s12888-015-0483-0 RESEARCH ARTICLE Open Access A pilot randomized controlled trial of a stepped care intervention package for depression in primary care in Nigeria Bibilola D Oladeji1*, Lola Kola1, Taiwo Abiona2, Alan A Montgomery3, Ricardo Araya4 and Oye Gureje1 Abstract Background: Depression is common in primary care and is often unrecognized and untreated. Studies are needed to demonstrate the feasibility of implementing evidence-based depression care provided by primary health care workers (PHCWs) in sub-Saharan Africa. We carried out a pilot two-parallel arm cluster randomized controlled trial of a package of care for depression in primary care. Methods: Six primary health care centers (PHCC) in two Local Government Areas of Oyo State, South West Nigeria were randomized into 3 intervention and 3 control clinics. Three PHCWs were selected for training from each of the participating clinics. The PHCWs from the intervention clinics were trained to deliver a manualized multicomponent stepped care intervention package for depression consisting of psychoeducation, activity scheduling, problem solving treatment and medication for severe depression. Providers from the control clinics delivered care as usual, enhanced by a refresher training on depression diagnosis and management. Outcome measures Patient’s Health Questionnaire (PHQ-9), WHO quality of Life instrument (WHOQOL-Bref) and the WHO disability assessment schedule (WHODAS) were administered in the participants’ home at baseline, 3 and 6 months. Results: About 98% of the consecutive attendees to the clinics agreed to have the screening interview. Of those screened, 284 (22.7%) were positive (PHQ-9 score ≥ 8) and 234 gave consent for inclusion in the study: 165 from intervention and 69 from control clinics. The rates of eligible and consenting participants were similar in the control and intervention arms. In all 85.9% (92.8% in intervention and 83% in control) of the participants were successfully administered outcome assessments at 6 months. The PHCWs had little difficulty in delivering the intervention package. At 6 months follow up, depression symptoms had improved in 73.0% from the intervention arm compared to 51.6% control. Compared to the mean scores at baseline, there was improvement in the mean scores on all outcome measures in both arms at six months. Conclusion: The results provide support for the feasibility of conducting a fully-powered randomized study in this setting and suggest that the instruments used may have the potential to detect differences between the arms. Trial registration number: ISRCTN46754188 (ISRTCN registry at isrtcn.com); registered 23 September 2013, details of the pilot study added 12/02/2015. Keywords: Depression, Primary care, Clinical trial, Stepped care intervention * 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 © 2015 Oladeji et al.; licensee BioMed Central. 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. Oladeji et al. BMC Psychiatry (2015) 15:96 Background Depression is a common problem in primary care and is often a prominent cause of unmet need for mental health care. In Nigeria, studies report prevalence estimates in the range of 10-20% in primary care [1,2]. However primary care providers often do not have the expertise to diagnose and manage depressed patients. In a WHO multi-centre study of mental illness in general health care, in which Nigeria was a participant, less than half of patients with mental disorders identified by the research diagnostic interview were detected by primary care physicians [3]. In most low and middle income countries, the bulk of primary health care is provided by non-physician primary health care workers. Even though figures are not available on the rates of mental illness identified by these primary care workers, it is likely that it might be lower than that for physicians. Some critics have raised concerns about the cross-cultural validity of mental health diagnosis such as depression [4] however, cross-national studies consistently support the presence of depression as diagnosed using standard diagnostic instruments and criteria across cultures [5]. The validity of depression diagnosis across cultures and specifically in Nigeria is further supported by the correlations between depression severity and disability, in keeping with findings from other cultures [6-8]. Nigeria like many low and middle income countries has inadequate specialist mental health personnel, with less than one psychiatrist to one million population and with the few available specialists inequitably concentrated in urban settings [9]. This lack of mental health human resources is one of the major factors contributing to the large treatment gap for mental disorders in Low and Middle income countries (LMICs) [10], which often exceeds 75% of those suffering from mental disorders in these countries. It has been suggested that the most efficient and effective way to reduce this gap in resource-constrained settings is to integrate mental health into primary health care [11]. There is evidence that a collaborative stepped care approach in which some tasks are performed by primary care providers offers the most effective way to implement this integration [12]. A stepped care approach involves the provision of different levels of treatment intensity with the most intensive treatment reserved for the more severe cases. Task shifting involves non-specialist health workers delivering most of the frontline care while specialists only provide ongoing training, supervision and support as well as care for the most severe cases [13]. Studies from LMIC of Asia and Latin America and a few recent studies from Africa suggest that effective low cost, low intensity treatments can be administered by lay or minimally trained primary health care workers. For example, in Chile, the effectiveness of a stepped-care programme was compared with usual care in primary-care management of depression among poor women in Santiago, Page 2 of 11 Chile [14]. The interventions were delivered mostly by non-medical primary care workers; the study reported a large and significant improvement in the outcome measures of patients in the stepped-care programme compared with usual care. A pilot study of task shifting in primary care in Zimbabwe demonstrated that it was feasible for lay workers to deliver an intervention f (...truncated)