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
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Purpose 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. Methods 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. Results 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. Conclusions 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.
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Three additional studies using stepped-care psychotherapy, a psychiatric screening and home nursing intervention, or a stepped nursing-led depression prevention intervention found no difference in mental health or cardiac outcomes compared with usual care over follow-up periods of at least 1 year.
“In contrast, 3 additional studies using stepped-care psychotherapy, a psychiatric screening and home nursing intervention, or a stepped nursing-led depression prevention intervention found no difference in mental health or cardiac outcomes compared with usual care over follow-up periods of at least 1 year. 196-199”
From Psychological Health, Well-Being, and the Mind-Heart-Body Connection: A Scientific Statement From the American Heart Association (2021) · cites this paper as [199]
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Self-citation
- Authors
- Pols, A. D., van Dijk, S. E., Bosmans, J. E., Hoekstra, T., van Marwijk, H. W. J., van Tulder, M. W., & Adriaanse, M. C.
- Affiliations
- Amsterdam Public Health (NL)
- Corresponding author
- Pols, Alide D.
- Bosmans, Judith E.
- Hoekstra, Trynke
- Adriaanse, Marcel C.
- Venue
- PLOS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2017-08-01
- Volume
- 12
- Issue
- 8
- Pages
- e0181023
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC5538642
- OpenAlex
- W4248714393
- Cited by
- 31
- References
- 18
- Citations by year
- 2026: 3 · 2025: 2 · 2023: 4 · 2022: 5 · 2021: 6 · 2020: 3 · 2019: 2 · 2018: 5 · 2017: 1
- FWCI
- 2.38
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- PLoS ONE (publishedVersion, cc-by)
- Pure Amsterdam UMC (publishedVersion, other-oa)
- Research Explorer (The University of Manchester) (publishedVersion, cc-by)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- Sussex Research Online (University of Sussex) (submittedVersion, cc-by)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Figshare (submittedVersion, cc-by)
- VU Research Portal (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- ZonMw (80-82310-97-12110)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Social Sciences › Psychology › Social Psychology › Mental Health Treatment and Access
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Keywords
- stepped-care intervention, subthreshold depression, type 2 diabetes, coronary artery disease, comorbidities, primary care, practice nurses, guided self-help, problem-solving therapy, expectant management, depression severity
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