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| Sponsor: | Forschungsinstitut der Diabetes Akademie Mergentheim |
|---|---|
| Collaborators: |
German Diabetes Center University of Gießen, Departement of Psychosomatics Koordinierungszentrum fuer Klinische Studien (KKS), University of Duesseldorf |
| Information provided by: | Forschungsinstitut der Diabetes Akademie Mergentheim |
| ClinicalTrials.gov Identifier: | NCT01009138 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Depressive Symptoms Diabetes Mellitus |
Behavioral: Diabetes-Specific Cognitive-Behavioral Group Sessions Behavioral: Educative Group Lesson and Discussion |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Development and Evaluation of a Diabetes-specific Cognitive Behavioural Treatment (DS-CBT) for Diabetic Patients With Subthreshold Depression |
| Estimated Enrollment: | 188 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Diabetes-Specific CBT (DS-CBT): Experimental
Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems
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Behavioral: Diabetes-Specific Cognitive-Behavioral Group Sessions
5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:
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|
Standard Diabetes Education: Active Comparator
Standard Diabetes Education Lessons will be given to quantify the unspecific antidepressive Effects of Participation in Group Sessions with social Contact and Acquisition of Knowledge.
|
Behavioral: Educative Group Lesson and Discussion
Standard Diabetes Education Lesson including
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Elevated rates for depression in diabetic patients are of clinical significance for diabetology. Depressive disorders are doubled compared to patients without diabetes. A meta-analysis showed that a proportion of 20% of diabetic patients showed subthreshold depression, defined as elevated depressive symptoms without meeting criteria for clinical depression. Depression in diabetes is associated with a reduced quality of life, more diabetes related distress, and higher health related costs. But besides this, depression in diabetes seems to be an independent negative prognostic factor for morbidity and mortality. Furthermore subthreshold depression is a major barrier of an effective self-management of the disease.
Until now antidepressive therapies are only evaluated in clinically depressed diabetic patients. For the majority of depressed diabetic patients suffering from subthreshold depression no evaluated specific intervention concept exists. Since subthreshold depression often is associated with diabetes related distress a diabetes specific intervention was developed to support patients to increase their problem solving skills, modify their depressive cognitions and improve their coping with diabetes related distress. It consists of five sessions and is delivered as a group intervention.
This study is an efficacy trial. In this randomized trial the efficacy of this newly developed intervention is compared to a control condition consisting of five standard diabetes education lessons. The primary outcome variable is the reduction of depressive symptoms twelve months after the intervention. Secondary outcome variables are the quality of life, metabolic parameters, self-care behavior and other psychosocial aspects. Furthermore the possible covariation between change of depressive symptoms and inflammatory and immune markers will be analyzed.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Bernhard Kulzer, PhD | (+49) 7931/ 594 ext 151 | kulzer@diabetes-zentrum.de |
| Contact: Norbert Hermanns, Prof., PhD | (+49) 7931/ 594 ext 553 | hermanns@diabetes-zentrum.de |
| Germany, Baden-Württemberg | |
| Forschungsinstitut der Diabetes Akademie Mergentheim e. V. | |
| Bad Mergentheim, Baden-Württemberg, Germany, 97980 | |
| Principal Investigator: | Bernhard Kulzer, PhD | Forschungsinstitut der Diabetes Akademie Mergentheim e. V. |
| Principal Investigator: | Norbert Hermanns, Prof., PhD | Forschungsinstitut der Diabetes Akademie Mergentheim e. V. |
| Study Director: | Thomas J Haak, Prof., MD | Diabetes Zentrum Mergentheim; Forschungsinstitut der Diabetes Akademie Mergentheim e. V. |
More Information
| Responsible Party: | Forschungsinstitut der Diabetes Akademie Mergentheim e. V. ( Bernhard Kulzer, PhD ) |
| Study ID Numbers: | FKZ 01GI0809 |
| Study First Received: | November 5, 2009 |
| Last Updated: | November 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT01009138 History of Changes |
| Health Authority: | Germany: Federal Ministry of Education and Research |
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Subthreshold Depression Diabetes-related Distress Minor Depression Light affective Disorder |
Subclinical depressive Symptoms Diabetes mellitus Late Complications Markers of Inflammation |
|
Metabolic Diseases Depression Mental Disorders Mood Disorders Diabetes Mellitus |
Endocrine System Diseases Glucose Metabolism Disorders Depressive Disorder Behavioral Symptoms |