Cognitive behavioural therapy in elderly type 2 diabetes patients with minor depression or mild major depression: study protocol of a randomized controlled trial (MIND-DIA)

Abstract

BackgroundThe global prevalence of diabetes among adults will be 6.4% in 2010 and will increase to 7.7% by 2030. Diabetes doubles the odds of depression, and 9% of patients with diabetes are affected by depressive disorders. When subclinical depression is included, the proportion of patients who have clinically relevant depressive symptoms increases to 26%. In patients aged over 65 years, the interaction of diabetes and depression has predicted increased mortality, complications, disability, and earlier occurrence of all of these adverse outcomes. These deleterious effects were observed even in minor depression, where the risk of mortality within 7 years was 4.9 times higher compared with diabetes patients who did not have depressive symptoms. In this paper we describe the design and methods of the Minor Depression and Diabetes trial, a clinical trial within the 'Competence Network for Diabetes mellitus', which is funded by the German Federal Ministry of Education and Research.Methods/DesignPatients' inclusion criteria are: Type 2 diabetes mellitus, 65 to 85 years of age, 3 to 6 depressive symptoms (minor depression or mild major depression). Our aim is to compare the efficacy of diabetes-specific cognitive behavioural therapy adapted for the elderly vs. intensified treatment as usual vs. a guided self-help intervention regarding improvement of health related quality of life as the primary outcome. The trial will be conducted as a multicentre, open, observer-blinded, parallel group (3 groups) randomized controlled trial. Patients will be randomized to one of the three treatment conditions. After 12 weeks of open-label therapy in all treatment conditions, both group interventions will be reduced to one session per month during the one-year long-term phase of the trial. At the one-year follow-up, all groups will be re-examined regarding the primary and secondary parameters, for example reduction of depressive symptoms, prevention of moderate/severe major depression, improvement of glycaemic control, mortality, and cost effectiveness. Depending on additional funding, the sample will be continuously observed as a prospective cohort; the primary outcome will be changed to mortality for all subsequent follow-up measurements.Trial registrationCurrent Controlled Trials Register (ISRCTN58007098).

State of the Science

“…Other investigators are currently examining physical activity as part of depression treatment among individuals with T2DM (Petrak et al, 2010). In the MIND-DIA trial, elderly persons (age 65 to 85) will be randomized into one of three arms: (1) group CBT delivered by trained psychologists who focus on strategies to overcome depression and diminish diabetes-related distress in addition to the use of pedometers to increase physical activity, (2) manualized guided self-help intervention or (3) treatment as usual.…”

Association Between Serum Endogenous Secretory Receptor for Advanced Glycation End Products and Risk of Type 2 Diabetes Mellitus with Combined Depression in the Chinese Population

“…The prevalence of diabetes has been increasing rapidly. 1 In 2010, the global prevalence rate of adult diabetes was 6.4%, and it is projected that it would increase to 7.7% by 2030. 1 The incidence of depression in patients with diabetes has been significantly higher than that of the general population.…”

“…1 In 2010, the global prevalence rate of adult diabetes was 6.4%, and it is projected that it would increase to 7.7% by 2030. 1 The incidence of depression in patients with diabetes has been significantly higher than that of the general population. [2][3][4] Depression and depression-related symptoms increase medical costs, reduce quality of life of patients, and increase risk of complications and mortality.…”

A Psychoeducational Intervention (SWEEP) for Depressed Women with Diabetes

“…Studies have also reported that health improvements can occur with effective CBT programs for depression and stress in persons with diabetes [20, 45]. In addition, other studies are using a CBT approach to treat mild and major depression in persons with diabetes [46, 47]. …”