The effect of a Diabetes-Specific Cognitive Behavioral Treatment Program (DIAMOS) for patients with diabetes and subclinical depression: results of a randomized controlled trial.

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.