CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 214 enrolled
Drug / intervention
Diabetes-Specific CBT (DS-CBT) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01009138
NCT01009138N/ACompleted

Development and Evaluation of a Diabetes-specific Cognitive Behavioural Treatment (DS-CBT) for Diabetic Patients With Subthreshold Depression

Forschungsinstitut der Diabetes Akademie Mergentheim·interventional·Posted Nov 6, 2009·Updated Oct 6, 2022

In Brief

A clinical study evaluating Diabetes-Specific CBT (DS-CBT) and Standard Diabetes Education for Depressive Symptoms and Diabetes Mellitus. Completed, enrolled 214 participants across 1 site.

Detailed Summary

This work is supported by the "Kompetenznetz Diabetes mellitus (Competence Network for Diabetes mellitus)" funded by the Federal Ministry of Education and Research (FKZ 01GI0809). Approximately one third of diabetic patients has elevated depressive symptoms. The majority of these patients are suffering from a subthreshold depression. In spite of the fact that subthreshold depression has an equivalent negative impact on the prognosis of diabetes as clinical depression, there is no specific intervention tool. The main objective of this project is to develop a diabetes specific cognitive behavioural treatment (DS-CBT) for diabetic patients with subthreshold depression. In a randomized trail DS-CBT is compared to standard diabetes education. A total of 188 diabetic patients will be recruited and randomly assigned to the two treatment conditions. The expected main outcome is the reduction of subthreshold depression under DS-CBT in a 12 month follow up. Secondary variables are improvement of glycaemic control, quality of life, diabetes self-management as well as reduction of health care costs and modification of inflammatory parameters.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 6, 2009
Enrollment StartNov 1, 2009
Primary CompletionMar 1, 2012
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.7 years ago

Interventions

Diabetes-Specific CBT (DS-CBT)behavioral

5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles: * Problem Analysis and Definition * Problem Solving Intervention * Cognitive Restructuring * Activation of personal and social Resources * Goal Definition and Agreement

Standard Diabetes Educationbehavioral

Standard Diabetes Education Lesson including * Health Care and specific Topics (e. g. Blood Pressure) * Social Aspects of Living with Diabetes * Diabetes Complications * Sports, Activities and Exercise * Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes * Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy