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

This study has been completed.
Sponsor:
Collaborators:
German Diabetes Center
University of Giessen
Coordination Center for Clinical Trials (KKS) Duesseldorf
Information provided by (Responsible Party):
Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim
ClinicalTrials.gov Identifier:
NCT01009138
First received: November 5, 2009
Last updated: March 18, 2013
Last verified: March 2013
  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 CBT (DS-CBT)
Behavioral: Standard Diabetes Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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

Primary Outcome Measures:
  • Depressive Symptoms (CES-D-Score) [ Time Frame: Baseline, 12 months-FU ] [ Designated as safety issue: No ]
    The Center for Epidemiologic Studies Depression Scale (CES-D) is used for the assessment of depressive symptoms. The decicive measurement of this primary outcome variable is conducted 12 month after termination of the treatment (12 month follow up). The difference of the CES-D scores between baseline and 12 months follow up is calculated.


Secondary Outcome Measures:
  • Quality of life (EQ-5D Score, WHO-5 Score) [ Time Frame: Baseline,12 months-FU ] [ Designated as safety issue: No ]
    The EQ-5D and the WHO-5 Wellbeing Index are used for the assessment of quality of life. The decicive measurement of the outcome variable is conducted 12 month after termination of the treatment (12 month follow up). The differences of the test scores between baseline and 12 months follow up are calculated.

  • Diabetes Distress (DDS-Score, PAID-Score) [ Time Frame: Baseline, 12 months-FU ] [ Designated as safety issue: No ]
    The Diabetes Distress Scale (DSS) and Problem areas in Diabetes Scale (PAID) are used for the assessment of diabetes-specific emotional distress. The decicive measurement of the outcome variable is conducted 12 month after termination of the treatment (12 month follow up). The differences of the test scores between baseline and 12 months follow up are calculated.

  • Diabetes Self-care Activity (SDSCA Score) [ Time Frame: Baseline, 12 months-FU ] [ Designated as safety issue: No ]
    The Summary of Diabetes Self-care Activities Measure (SDSCA) is used for the assessment of diabetes self-care activitiy. The decicive measurement of the outcome variable is conducted 12 month after termination of the treatment (12 month follow up). The difference of the test scores between baseline and 12 months follow up is calculated.

  • Diabetes Acceptance (AADQ Score) [ Time Frame: Baseline, 12 months-FU ] [ Designated as safety issue: No ]
    The Acceptance and Action Diabetes Questionnaire (AADQ) is used for the assessment of diabetes acceptance. The decicive measurement of the outcome variable is conducted 12 month after termination of the treatment (12 month follow up). The difference of the test scores between baseline and 12 months follow up is calculated.

  • Inflammatory Markers (CRP, IL-6, IL-1RA, IL-18, TNF-alpha, DHEA-S, 5-HIAA, Cortisol) [ Time Frame: Baseline, 12 months-FU ] [ Designated as safety issue: Yes ]
    Inflammatory Markers are used for the assessment of distress-associated immune activity. The decicive measurement of the outcome variable is conducted 12 month after termination of the treatment (12 month follow up). The differences of the serum-/ uric concentrations between baseline and 12 months follow up is calculated.

  • Health Care Costs [ Time Frame: Baseline, 12 months-FU ] [ Designated as safety issue: No ]
    The health-care costs are assessed by retrospective interviews refering to the last 6 months before each interview. Medical, medicinal and therapeutic interventions as well as other health-care supplies are assessed. The decicive measurement of the outcome variable is conducted 12 month after termination of the treatment (12 month follow up). The difference of the health-care costs before baseline and before 12 months follow up is calculated.

  • Glycemic Control (HbA1c) [ Time Frame: Baseline, 12 months-FU ] [ Designated as safety issue: Yes ]
    The HbA1c represents the glycemic control during the last 3 months. The decicive measurement of the outcome variable is conducted 12 month after termination of the treatment (12 month follow up). The difference of the HbA1c values between baseline and 12 months follow up is calculated.

  • Body Weight (kg) [ Time Frame: Baseline, 12 months-FU ] [ Designated as safety issue: No ]
    The body weight serves as a measure of life style change. The decicive measurement of the outcome variable is conducted 12 month after termination of the treatment (12 month follow up). The difference in the weight between baseline and 12 months follow up is calculated.


Enrollment: 214
Study Start Date: November 2009
Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diabetes-Specific CBT (DS-CBT)
Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems
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
Other Name: Diabetes-Specific Cognitive-Behavioral Group Sessions
Active Comparator: Standard Diabetes Education
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: 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
Other Name: Educative Group Lesson and Discussion

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
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
Coordination Center for Clinical Trials (KKS) 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 by Forschungsinstitut der Diabetes Akademie Mergentheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Norbert Hermanns, Prof. Dr., Forschungsinstitut der Diabetes Akademie Mergentheim
ClinicalTrials.gov Identifier: NCT01009138     History of Changes
Other Study ID Numbers: FKZ 01GI0809
Study First Received: November 5, 2009
Last Updated: March 18, 2013
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:
Depression
Depressive Disorder
Diabetes Mellitus
Behavioral Symptoms
Mood Disorders
Mental Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014