Effectiveness of a stepped-care intervention to prevent major depression in patients with type 2 diabetes mellitus and/or coronary heart disease and subthreshold depression: A pragmatic cluster randomized controlled trial

• Published in: PloS one 2017-08, Vol.12 (8), p.e0181023-e0181023
• Main Authors: Pols, Alide D, van Dijk, Susan E, Bosmans, Judith E, Hoekstra, Trynke, van Marwijk, Harm W J, van Tulder, Maurits W, Adriaanse, Marcel C
• Format: Article
• Language: English
• Subjects: Age; Aged; Cardiovascular disease; Cardiovascular diseases; Clinical trials; Cluster Analysis; Comorbidity; Coronary artery disease; Coronary Disease - complications; Coronary Disease - psychology; Depressive Disorder, Major - prevention & control; Diabetes; Diabetes mellitus; Diabetes Mellitus, Type 2 - complications; Diabetes Mellitus, Type 2 - psychology; Disease control; Epidemiology; Female; Follow-Up Studies; General Practitioners; Health care; Health sciences; Heart; Heart diseases; Humans; Incidence; Intervention; Major depressive disorder; Male; Management; Medicine and Health Sciences; Mental depression; Middle Aged; Mortality; Netherlands; Older people; Patients; People and Places; Prevention; Primary care; Primary health care; Primary Health Care - organization & administration; Problem Solving; Psychiatry; Public health; Research and Analysis Methods; Self-Help Groups; Severity of Illness Index; Studies; Surveys and Questionnaires; Time Factors; Watchful Waiting
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0181023

Given the public health significance of poorly treatable co-morbid major depressive disorders (MDD) among patients with type 2 diabetes mellitus (DM2) and coronary heart disease (CHD), we need to investigate whether strategies to prevent the development of major depression could reduce its burden of disease. We therefore evaluated the effectiveness of a stepped-care program for subthreshold depression in comparison with usual care in patients with DM2 and/or CHD. A cluster randomized controlled trial, with 27 primary care centers serving as clusters. A total of 236 DM2 and/or CHD patients with subthreshold depression (nine item Patient Health Questionnaire (PHQ-9) score ≥ 6, no current MDD according to DSM-IV criteria) were allocated to the intervention group (N = 96) or usual care group (n = 140). The stepped-care program was delivered by trained practice nurses during one year and consisted of four sequential treatment steps: watchful waiting, guided self-help, problem solving treatment and referral to the general practitioner. The primary outcome was the 12-month cumulative incidence of MDD as measured with the Mini International Neuropsychiatric Interview (MINI). Secondary outcomes included severity of depression (measured by PHQ-9) at 3, 6, 9 and 12 months. Of 236 patients (mean age, 67,5 (SD 10) years; 54.7% men), 210 (89%) completed the MINI at 12 months. The cumulative incidence of MDD was 9 of 89 (10.1%) participants in the intervention group and 12 of 121 (9.9%) participants in the usual care group. We found no statistically significant overall effect of the intervention (OR = 1.21; 95% confidence interval (0.12 to 12.41)) and there were no statistically significant differences in the course or severity of depressive symptoms between the two groups. This study suggest that Step-Dep was not more effective in preventing MDD than usual care in a primary care population with DM2 and/or CHD and subthreshold depression.