Evaluation of a Diabetes-specific Cognitive Behavioural Treatment for Subthreshold Depression

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.

Conditions

• Depressive Symptoms
• Diabetes Mellitus

Interventions

BEHAVIORAL

Diabetes-Specific CBT (DS-CBT)

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

BEHAVIORAL

Standard Diabetes Education

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

Sponsors & Collaborators

• German Diabetes Center

  collaborator OTHER

• University of Giessen

  collaborator OTHER

• Heinrich-Heine University, Duesseldorf

  collaborator OTHER

• Forschungsinstitut der Diabetes Akademie Mergentheim

  lead OTHER

Principal Investigators

• Bernhard Kulzer, PhD · Forschungsinstitut der Diabetes Akademie Mergentheim e. V.

• Norbert Hermanns, Prof., PhD · Forschungsinstitut der Diabetes Akademie Mergentheim e. V.

• Thomas J Haak, Prof., MD · Diabetes Zentrum Mergentheim; Forschungsinstitut der Diabetes Akademie Mergentheim e. V.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-11-30

Primary Completion

2012-03-31

Completion

2012-05-31

Countries

• Germany

Study Locations