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Cognitve behavioural therapy (CBT) versus sertraline in patients with depression and poorly controlled diabetes mellitus: Diabetes and Depression Study - A randomized controlled trial (DAD Studie)

Laufzeit: 01.01.2006 - 31.12.2011

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Cognitive behavioural therapy vs. sertraline in patients with depression and poorly controlled diabe-tes mellitus: A randomized controlled trial Title Cognitive behavioural therapy (CBT) vs. sertraline in patients with depression and poorly controlled diabetes mellitus: A randomized controlled trial - Diabetes and Depression Study (DAD Study) - Phase Phase IV Indication Patients with insulin-treated type 1 or type 2 diabetes mellitus with depression and HbA1c-value > 7,5 % within the nine...Cognitive behavioural therapy vs. sertraline in patients with depression and poorly controlled diabe-tes mellitus: A randomized controlled trial Title Cognitive behavioural therapy (CBT) vs. sertraline in patients with depression and poorly controlled diabetes mellitus: A randomized controlled trial - Diabetes and Depression Study (DAD Study) - Phase Phase IV Indication Patients with insulin-treated type 1 or type 2 diabetes mellitus with depression and HbA1c-value > 7,5 % within the nine preceding months. Objectives To compare the efficacy of diabetes-specific cognitive behavioural therapy vs. antidepressive medi-cation, specifically the selective serotonin reuptake inhibitor (SSRI) sertraline, regarding improve-ment of glycaemic control in patients with poorly controlled diabetes and depression. Trial Design Multicentre randomised controlled trial (RCT) comparing sertaline vs. CBT. After 12 weeks of open-label therapy, only the treatment-responders (50% improvement of depression) of both groups will be included in the one-year long-term phase of the study. In the long-term phase, diabetological treatment as usual will be given to both groups. CBT-responders will receive no further treatment, while SSRI-responders will be given a sustained sertraline regimen as relapse prevention. The pri-mary outcome variable is a 1% improvement of the HbA1c at the one-year follow-up; the most important secondary outcome variable is remission of depression. » weiterlesen» einklappen

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