Offene, Beobachter-verblindete, randomisierte, kontrollierte, multizentrische, Parallelgruppen-Studie, kognitiv behaviorale Therapie bei älteren Patineten mit Diabetes Typ 2 und Minor oder leichter Major Depression (MIND-DIA Studie im Rahmen Kompetenznetz Diabetes)
Laufzeit: 01.01.2009 - 31.12.2013
Kurzfassung
Background: Minor depression or mild major depression has a consider-able impact on quality of life and worsens the prognosis particularly among elderly people with type 2 diabetes. Depressive symptoms pre-dicts mortality, complications, and disability in elderly diabetes patients. No randomized controlled treatment trial evaluating psychotherapy was conducted for this specific population at risk. Goals: The principal aim is to evaluate the efficacy of a diabetes-specific cognitive...Background: Minor depression or mild major depression has a consider-able impact on quality of life and worsens the prognosis particularly among elderly people with type 2 diabetes. Depressive symptoms pre-dicts mortality, complications, and disability in elderly diabetes patients. No randomized controlled treatment trial evaluating psychotherapy was conducted for this specific population at risk. Goals: The principal aim is to evaluate the efficacy of a diabetes-specific cognitive behavioural group therapy (CBT) for elderly patients with type 2 diabetes regarding quality of life and depression symptoms. Subjects: Type 2 diabetes patients, 65 to 85 years of age, with minor depression or mild major depression. Design: Multicentre randomised controlled trial comparing medical treatment as usual vs. weekly sessions of cognitive behavioural group therapy or dia-betes self-help group. After 12 weeks of open-label therapy, both group interventions will be reduced to one monthly session in the long-term phase of the study. For the cognitive behavioural therapy group the intervention will be changed into a guided self-help group with a focus on cognitive behav-ioural techniques. The primary outcome variable is a significant improve-ment of health-related quality of life at the one-year follow-up; the most important secondary outcome variables are reduction of depression symptoms, prevention of severe major depression, reduction of health-care costs and mortality. Expected outcome: We expect that (a) CBT is significantly more effective than treatment as usual in terms of improve-ment of quality of life and depression symptoms in the one year follow-up; and (b) CBT is significantly more effective than self-help groups in terms of improvement of quality of life in the one year follow-up.» weiterlesen» einklappen