1. 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
- Author
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Barengo, Noel Christopher, Pols, Alide D, van Dijk, Susan E, Bosmans, Judith E, Hoekstra, Trynke, van Marwijk, Harm W J, van Tulder, Maurits W, Adriaanse, Marcel C, Health Economics and Health Technology Assessment, Methodology and Applied Biostatistics, Health Sciences, APH - Health Behaviors & Chronic Diseases, APH - Methodology, APH - Mental Health, AMS - Sports and Work, APH - Societal Participation & Health, AMS - Ageing and Morbidity, General practice, and Epidemiology and Data Science
- Subjects
Male ,Time Factors ,Medical Doctors ,Health Care Providers ,lcsh:Medicine ,Nurses ,Coronary Disease ,Comorbidity ,Severity of Illness Index ,Vascular Medicine ,0302 clinical medicine ,Endocrinology ,Surveys and Questionnaires ,Medicine and Health Sciences ,Cluster Analysis ,Coronary Heart Disease ,030212 general & internal medicine ,lcsh:Science ,Problem Solving ,Netherlands ,Medicine(all) ,Multidisciplinary ,Agricultural and Biological Sciences(all) ,Depression ,Incidence ,Middle Aged ,Type 2 Diabetes ,Self-Help Groups ,Professions ,Female ,Research Article ,Drug Research and Development ,Patients ,Endocrine Disorders ,Cardiology ,Research and Analysis Methods ,03 medical and health sciences ,SDG 3 - Good Health and Well-being ,General Practitioners ,Physicians ,Mental Health and Psychiatry ,Diabetes Mellitus ,Humans ,Clinical Trials ,Watchful Waiting ,Primary Care ,Aged ,Pharmacology ,Depressive Disorder, Major ,Primary Health Care ,Mood Disorders ,Biochemistry, Genetics and Molecular Biology(all) ,lcsh:R ,Randomized Controlled Trials ,030227 psychiatry ,Health Care ,Diabetes Mellitus, Type 2 ,Metabolic Disorders ,People and Places ,lcsh:Q ,Population Groupings ,Clinical Medicine ,Follow-Up Studies - Abstract
Purpose\ud \ud 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.\ud \ud Methods\ud \ud 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.\ud \ud Results\ud \ud 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.\ud \ud Conclusions\ud \ud 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.
- Published
- 2017