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

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

Resource links provided by NLM:

MedlinePlus related topics: Depression Diabetes

U.S. FDA Resources

Further study details as provided by Forschungsinstitut der Diabetes Akademie Mergentheim:

Primary Outcome Measures:

Depressive Symptoms (CES-D) [ Time Frame: baseline, 2 weeks after treatment, 6 months-FU, 12 months-FU ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life (EQ-5D, WHO-5) [ Time Frame: baseline, 2 weeks after treatment, 6 months-FU, 12 months-FU ] [ Designated as safety issue: No ]
Diabetes Distress (DDS, PAID) [ Time Frame: baseline, 2 weeks after treatment, 6 months-FU, 12 months-FU ] [ Designated as safety issue: No ]
Diabetes Self-Management (SDSCA)/ Self-Care Behaviour (HbA1c, Weight) [ Time Frame: baseline, 2 weeks after treatment, 6 months-FU, 12 months-FU ] [ Designated as safety issue: No ]
Diabetes Acceptance (AADQ) [ Time Frame: baseline, 2 weeks after treatment, 6 months-FU, 12 months-FU ] [ Designated as safety issue: No ]
Inflammatory Markers (CRP, IL-6, IL-1RA, IL- 18, TNF-alpha, DHEA-S, 5-HIAA, Cortisol) [ Time Frame: baseline, 2 weeks after treatment, 12 months-FU ] [ Designated as safety issue: Yes ]
Health Care Costs [ Time Frame: baseline, 6 months-FU, 12 months-FU ] [ Designated as safety issue: No ]

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	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: Problem Analysis and Definition Problem Solving Intervention Cognitive Restructuring Activation of personal and social Resources Goal Definition and Agreement
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 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

Arms

Assigned Interventions

Diabetes-Specific CBT (DS-CBT): Experimental

Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems

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:

Problem Analysis and Definition
Problem Solving Intervention
Cognitive Restructuring
Activation of personal and social Resources
Goal Definition and Agreement

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

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

Detailed Description:

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

Criteria

Inclusion Criteria:

Diabetes mellitus
Elevated depressive symptoms (regarding to CES-D)
Age >= 18 and <=70
Sufficient German language skills
Informed consent

Exclusion Criteria:

Current MDD
Current schizophrenia/ psychotic disorder, eating disorder, bipolar disorder, addictive disorder, personality disorder
Current antidepressive medication
Current psychotherapy
Severe physical illness (i.e. cancer)
Being bedridden
Guardianship

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01009138

Contacts

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

Locations

Germany, Baden-Württemberg
Forschungsinstitut der Diabetes Akademie Mergentheim e. V.
Bad Mergentheim, Baden-Württemberg, Germany, 97980

Sponsors and Collaborators

Forschungsinstitut der Diabetes Akademie Mergentheim

German Diabetes Center

University of Gießen, Departement of Psychosomatics

Koordinierungszentrum fuer Klinische Studien (KKS), University of Duesseldorf

Investigators

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

No publications provided

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

Keywords provided by Forschungsinstitut der Diabetes Akademie Mergentheim:

Subthreshold Depression
Diabetes-related Distress
Minor Depression
Light affective Disorder

Subclinical depressive Symptoms
Diabetes mellitus
Late Complications
Markers of Inflammation

Additional relevant MeSH terms:

Metabolic Diseases
Depression
Mental Disorders
Mood Disorders
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on February 08, 2010