Behavioral medicine interventions are effective in diabetes treatment, especially in patients with a high level of diabetes-related distress, difficulty in coping, or insufficient blood glucose awareness.
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).
BackgroundDepression and elevated depression symptoms are more prevalent in patients with type 2 diabetes than in those without diabetes and are associated with adverse health outcomes and increased total healthcare utilization. This suggests that more effective depression treatment might not only improve health outcome, but also reduce costs. However, there is a lack of evidence on (cost-) effectiveness of treatment options for minor and mild-major depression in patients with type 2 diabetes. In this paper we describe the design and methods of the economic evaluation, which will be conducted alongside the MIND-DIA trial (Cognitive behaviour therapy in elderly type 2 diabetes patients with minor or mild-major depression). The objective of the economic evaluation (MIND-DIA CEA) is to examine incremental cost-effectiveness of a diabetes specific cognitive behaviour group therapy (CBT) as compared to intensified treatment as usual (TAU) and to a guided self-help group intervention (SH).Methods/DesignPatients will be followed for 15 months. During this period data on health sector costs, patient costs and societal productivity/time costs will be collected in addition to clinical data. Person-years free of moderate/severe major depression, quality adjusted life years (QALYs), and cumulative costs will be estimated for each arm of the trial (CBT, TAU and SH). To determine cost-effectiveness of the CBT, differences in costs and effects between the CBT group and TAU/SH group will be calculated.DiscussionCBT is a potentially effective treatment option to improve quality of life and to avoid the onset of a moderate/severe major depression in elderly patients with type 2 diabetes and minor or mild-major depression. This hypothesis will be evaluated in the MIND-DIA trial. Based on these results the associated economic evaluation will provide additional evidence on the cost-effectiveness of CBT in this target population. Methodological strengths and weaknesses of the planned economic evaluation are discussed.Trial registrationThe MIND-DIA study has been registered at the Current Controlled Trials Register (ISRCTN58007098).
Zusammenfassung. Theoretischer Hintergrund: In überwiegend US-amerikanischen Studien konnten individuelle, partnerschaftliche und kontextuelle Faktoren identifiziert werden, die das Eingehen einer außerpartnerschaftlichen Beziehung beeinflussen. Fragestellung: Welche der identifizierten Risikofaktoren können als Prädiktoren für das Eingehen von Untreue anhand einer deutschen Stichprobe repliziert werden? Methode: Fragebogenerhebung an einer Stichprobe von N = 768 jungen Erwachsenen im Alter von 18–40 Jahren. Erfasst wurden soziodemografische, individuelle (Einstellungen, Religiosität, Bindungsstil), partnerschaftliche (partnerschaftliche und sexuelle Zufriedenheit, Dauer der Partnerschaft) sowie kontextuelle Faktoren (beruflich bedingte Reisetage, Gelegenheiten). Ergebnisse: Eine niedrige partnerschaftliche sowie sexuelle Zufriedenheit, eine gering ausgeprägte Religiosität und als hoch eingeschätzte Gelegenheiten erhöhen die Wahrscheinlichkeit für das Eingehen einer Außenbeziehung. Weiterhin erwiesen sich das Alter, die Dauer der primären Partnerschaft und die Anzahl der beruflich bedingten Reisetage als signifikant bedeutsame Prädiktoren. Schlussfolgerungen: Die Ergebnisse stehen weitgehend in Einklang mit den Befunden der US-amerikanischen Untersuchungen. Spezifische Implikationen für zukünftige Fragestellungen werden diskutiert.
Zusammenfassung. Theoretischer Hintergrund: Studien aus den USA zeigen, dass das Erleben von Untreue ein bedeutendes Problem für viele Paare darstellt und zu Depressivität, Belastungsreaktionen und Trennung bzw. Scheidung führen kann. Fragestellung: Ist die individuelle und partnerschaftliche Belastung bei Paaren, die zu Beginn einer Paarberatung Konflikte im Zusammenhang mit Außenbeziehungen berichten höher, als bei Paaren, die keine Konflikte durch Außenbeziehungen angeben? Methode: Re-analytische Überprüfung der Daten von N = 464 Paaren, die um Paarberatung nachgesucht hatten ( Kröger, Hahlweg & Klann, 2007 ). Erfasst wurden die individuelle Belastung (Depression, Psychosomatische Beschwerden) und Partnerschaftsvariablen (Zufriedenheit, Problembereiche). Ergebnisse: Paare, die Konflikte im Zusammenhang mit Außenbeziehungen angaben, waren im Vergleich zu Paaren ohne diese Konflikte insgesamt depressiver, unzufriedener mit ihrer Partnerschaft und gaben mehr partnerschaftliche Probleme an. Schlussfolgerung: Es konnten Zusammenhänge zwischen dem Erleben von Untreue und einer hohen individuellen und partnerschaftlichen Belastung gezeigt werden. Spezifische Implikationen für zukünftige Fragestellungen werden diskutiert.
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