Norbert Hermanns1, Andreas Schmitt2, Annika Gahr2, Christian Herder3, Bettina Nowotny4, Michael Roden5, Christian Ohmann6, Johannes Kruse7, Thomas Haak8, Bernhard Kulzer9. 1. Research Institute Diabetes Academy Mergentheim, Bad Mergentheim, Germany Diabetes Center Mergentheim, Bad Mergentheim, Germany Institute of Clinical Psychology and Psychotherapy, University of Bamberg, Bamberg, Germany hermanns@diabetes-zentrum.de. 2. Research Institute Diabetes Academy Mergentheim, Bad Mergentheim, Germany. 3. Institute for Clinical Diabetology, German Diabetes Center at Heinrich-Heine University Düsseldorf, Düsseldorf, Germany German Center for Diabetes Research, Partner Düsseldorf, Düsseldorf, Germany. 4. Institute for Clinical Diabetology, German Diabetes Center at Heinrich-Heine University Düsseldorf, Düsseldorf, Germany Department of Endocrinology and Diabetology, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany. 5. Institute for Clinical Diabetology, German Diabetes Center at Heinrich-Heine University Düsseldorf, Düsseldorf, Germany German Center for Diabetes Research, Partner Düsseldorf, Düsseldorf, Germany Department of Endocrinology and Diabetology, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany. 6. Coordination Center for Clinical Trials, University of Düsseldorf, Düsseldorf, Germany. 7. Klinik für Psychosomatik und Psychotherapie des Universitätsklinikum Giessen und Marburg, Justus-Liebig-Universität Giessen und Philipps-Universität Marburg, Giessen, Germany. 8. Research Institute Diabetes Academy Mergentheim, Bad Mergentheim, Germany Diabetes Center Mergentheim, Bad Mergentheim, Germany. 9. Research Institute Diabetes Academy Mergentheim, Bad Mergentheim, Germany Diabetes Center Mergentheim, Bad Mergentheim, Germany Institute of Clinical Psychology and Psychotherapy, University of Bamberg, Bamberg, Germany.
Abstract
OBJECTIVE: Subclinical depression is one of the most frequent mental comorbidities in patients with diabetes and is associated with a poorer long-term prognosis. Since there is a lack of specific intervention concepts for this patient group, a self-management-oriented group program (DIAMOS [Diabetes Motivation Strengthening]) was newly developed and evaluated in a randomized trial. RESEARCH DESIGN AND METHODS: DIAMOS is composed of cognitive behavioral interventions aiming at the reduction of diabetes distress. The active control group (CG) received diabetes education. The primary outcome was depressive symptoms. Secondary outcomes were diabetes distress, well-being, self-care behavior, diabetes acceptance, diabetes treatment satisfaction, HbA1c, and subclinical inflammation. RESULTS:Two hundred fourteen participants (mean age 43.3 ± 13.3 years, female sex 56.5%, type 2 diabetes 34.1%, mean diabetes duration 14.2 ± 10.5 years, HbA1c 8.9 ± 1.8%, BMI 28.7 ± 71 kg/m(2)) were randomized. The 12-month follow-up revealed a significantly stronger reduction of depressive symptoms (Center for Epidemiologic Studies Depression Scale score) in the DIAMOS group compared with the CG (Δ3.9 [95% CI 0.6-7.3], P = 0.021). Of the secondary variables, the Patient Health Questionnaire-9 (Δ1.7 [95% CI 0.2-3.2], P = 0.023), Problem Areas in Diabetes scale (Δ8.2 [95% CI 3.1-13.3], P = 0.002), and Diabetes Distress Scale scores (Δ0.3 [95% CI 0.1-0.5], P = 0.012) displayed significant treatment effects. Moreover, the risk of incident major depression in the DIAMOS group was significantly reduced (odds ratio 0.63 [95% CI 0.42-0.96], P = 0.028). Inflammatory variables were not substantially affected. CONCLUSIONS: DIAMOS is more effective in lowering depressive symptoms and diabetes-related distress in diabetic patients with subclinical depression. DIAMOS also has a preventive effect with respect to the incidence of major depression.
RCT Entities:
OBJECTIVE:Subclinical depression is one of the most frequent mental comorbidities in patients with diabetes and is associated with a poorer long-term prognosis. Since there is a lack of specific intervention concepts for this patient group, a self-management-oriented group program (DIAMOS [Diabetes Motivation Strengthening]) was newly developed and evaluated in a randomized trial. RESEARCH DESIGN AND METHODS: DIAMOS is composed of cognitive behavioral interventions aiming at the reduction of diabetes distress. The active control group (CG) received diabetes education. The primary outcome was depressive symptoms. Secondary outcomes were diabetes distress, well-being, self-care behavior, diabetes acceptance, diabetes treatment satisfaction, HbA1c, and subclinical inflammation. RESULTS: Two hundred fourteen participants (mean age 43.3 ± 13.3 years, female sex 56.5%, type 2 diabetes 34.1%, mean diabetes duration 14.2 ± 10.5 years, HbA1c 8.9 ± 1.8%, BMI 28.7 ± 71 kg/m(2)) were randomized. The 12-month follow-up revealed a significantly stronger reduction of depressive symptoms (Center for Epidemiologic Studies Depression Scale score) in the DIAMOS group compared with the CG (Δ3.9 [95% CI 0.6-7.3], P = 0.021). Of the secondary variables, the Patient Health Questionnaire-9 (Δ1.7 [95% CI 0.2-3.2], P = 0.023), Problem Areas in Diabetes scale (Δ8.2 [95% CI 3.1-13.3], P = 0.002), and Diabetes Distress Scale scores (Δ0.3 [95% CI 0.1-0.5], P = 0.012) displayed significant treatment effects. Moreover, the risk of incident major depression in the DIAMOS group was significantly reduced (odds ratio 0.63 [95% CI 0.42-0.96], P = 0.028). Inflammatory variables were not substantially affected. CONCLUSIONS: DIAMOS is more effective in lowering depressive symptoms and diabetes-related distress in diabeticpatients with subclinical depression. DIAMOS also has a preventive effect with respect to the incidence of major depression.
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