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.

Negative association between depression and diabetes control only when accompanied by diabetes-specific distress.

Evidence of the negative impact of depression on glycaemic control is equivocal, and diabetes-related distress has been proposed as potential mediator. 466 diabetes patients were cross-sectionally assessed for depression (Center for Epidemiologic Studies Depression Scale), diabetes-related distress (Diabetes Distress Scale), and glycaemic control (HbA1c). We distinguished the associations of depression and diabetes distress with glycaemic control using analysis of variance and multiple regression. Neither patients with depression only nor diabetes distress only differed significantly from controls regarding HbA1c. However, HbA1c was substantially increased when both conditions were present (9.2 vs. 8.6 %, P = 0.01). As in previous studies, we observed a significant association between depression and hyperglycaemia (P < 0.01). However, a mediation analysis revealed that this association in fact depended on the presence of diabetes distress (P < 0.01). Depression seems to be associated with hyperglycaemia particularly when accompanied by diabetes distress, suggesting that adjusting clinical procedures regarding diabetes distress may facilitate the identification and care of high-risk patients.

The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control.

BACKGROUND: Though several questionnaires on self-care and regimen adherence have been introduced, the evaluations do not always report consistent and substantial correlations with measures of glycaemic control. Small ability to explain variance in HbA1c constitutes a significant limitation of an instrument's use for scientific purposes as well as clinical practice. In order to assess self-care activities which can predict glycaemic control, the Diabetes Self-Management Questionnaire (DSMQ) was designed. METHODS: A 16 item questionnaire to assess self-care activities associated with glycaemic control was developed, based on theoretical considerations and a process of empirical improvements. Four subscales, 'Glucose Management' (GM), 'Dietary Control' (DC), 'Physical Activity' (PA), and 'Health-Care Use' (HU), as well as a 'Sum Scale' (SS) as a global measure of self-care were derived. To evaluate its psychometric quality, 261 patients with type 1 or 2 diabetes were assessed with the DSMQ and an established analogous scale, the Summary of Diabetes Self-Care Activities Measure (SDSCA). The DSMQ's item and scale characteristics as well as factorial and convergent validity were analysed, and its convergence with HbA1c was compared to the SDSCA. RESULTS: The items showed appropriate characteristics (mean item-total-correlation: 0.46 ± 0.12; mean correlation with HbA1c: -0.23 ± 0.09). Overall internal consistency (Cronbach's alpha) was good (0.84), consistencies of the subscales were acceptable (GM: 0.77; DC: 0.77; PA: 0.76; HU: 0.60). Principal component analysis indicated a four factor structure and confirmed the designed scale structure. Confirmatory factor analysis indicated appropriate fit of the four factor model. The DSMQ scales showed significant convergent correlations with their parallel SDSCA scales (GM: 0.57; DC: 0.52; PA: 0.58; HU: n/a; SS: 0.57) and HbA1c (GM: -0.39; DC: -0.30; PA: -0.15; HU: -0.22; SS: -0.40). All correlations with HbA1c were significantly stronger than those obtained with the SDSCA. CONCLUSIONS: This study provides preliminary evidence that the DSMQ is a reliable and valid instrument and enables an efficient assessment of self-care behaviours associated with glycaemic control. The questionnaire should be valuable for scientific analyses as well as clinical use in both type 1 and type 2 diabetes patients.

Within-trial economic evaluation of diabetes-specific cognitive behaviour therapy in patients with type 2 diabetes and subthreshold depression.

BACKGROUND: Despite the high prevalence of subthreshold depression in patients with type 2 diabetes, evidence on cost-effectiveness of different therapy options for these patients is currently lacking. METHODS/DESIGN: Within-trial economic evaluation of the diabetes-specific cognitive behaviour therapy for subthreshold depression. Patients with diabetes and subthreshold depression are randomly assigned to either 2 weeks of diabetes-specific cognitive behaviour group therapy (n = 104) or to standard diabetes education programme only (n = 104). Patients are followed for 12 months. During this period data on total health sector costs, patient costs and societal productivity costs are collected in addition to clinical data. Health related quality of life (the SF-36 and the EQ-5D) is measured at baseline, immediately after the intervention, at 6 and at 12 months after the intervention. Quality adjusted life years (QALYs), and cumulative costs will be estimated for each arm of the trial. Cost-effectiveness of the diabetes-specific cognitive behaviour group therapy will be analysed from the perspective of the German statutory health insurance and from the societal perspective. To this end, incremental cost-effectiveness ratio (ICER) in terms of cost per QALY gained will be calculated. DISCUSSION: Some methodological issues of the described economic evaluation are discussed. TRIAL REGISTRATION: The trial has been registered at the Clinical Trials Register (NCT01009138).