Evaluation of a Diabetes-specific Cognitive Behavioural Treatment for Subthreshold Depression
Condition: Depressive Symptoms; Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Depression; Depressive Disorder
Study type: Interventional

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.
    

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.
    

Intervention name(s): Diabetes-Specific CBT (DS-CBT); Standard Diabetes Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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 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 intervention name(s): Diabetes-Specific Cognitive-Behavioral Group Sessions; Educative Group Lesson and Discussion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Subthreshold Depression; Diabetes-related Distress; Minor Depression; Light affective Disorder; Subclinical depressive Symptoms; Diabetes mellitus; Late Complications; Markers of Inflammation