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Randomized Controlled Trial
. 2015 Jul 7:15:148.
doi: 10.1186/s12888-015-0542-6.

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

Oye Gureje  1 , Bibilola Damilola Oladeji  2 , Ricardo Araya  3 , Alan A Montgomery  4
Affiliations
Randomized Controlled Trial

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

Oye Gureje et al. BMC Psychiatry. .

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).

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Fig. 1
Treatment flow chart
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References

    1. Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006;3:e442. doi: 10.1371/journal.pmed.0030442. - DOI - PMC - PubMed
    1. Gureje O, Kola L, Afolabi E. Epidemiology of major depressive disorder in elderly Nigerians in the Ibadan Study of Ageing: a community-based survey. Lancet. 2007;370:957–964. doi: 10.1016/S0140-6736(07)61446-9. - DOI - PMC - PubMed
    1. Abiodun OA. A study of mental morbidity among primary care patients in Nigeria. Compr Psychiatry. 1993;34(1):10–13. doi: 10.1016/0010-440X(93)90030-8. - DOI - PubMed
    1. Gureje O, Obikoya B, Ikuesan A. Prevalence of specific psychiatric disorders in an urban primary care setting. East Afr Med J. 1992;69:282–287. - PubMed
    1. Lund C, Breen A, Flisher AJ, Kakuma R, Corrigall J, Joska JA, et al. Poverty and common mental disorders in low and middle income countries: A systematic review. Soc Sci Med. 2010;71:517–528. doi: 10.1016/j.socscimed.2010.04.027. - DOI - PMC - PubMed

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