Depression and Diabetes Control Trial

Summary

This randomised controlled trial evaluates a cognitive-behavioural intervention for diabetes patients with suboptimal glycaemic control and comorbid depressive symptoms and/or diabetes distress. The main outcome is the improvement of suboptimal glycaemic control (HbA1c). Secondary outcomes are effects on depressive symptoms, diabetes distress, self-care behaviour, diabetes acceptance and quality of life. The treatment group will be treated with a cognitive-behavioural group treatment comprising specific interventions to improve glycaemic control and reduce diabetes distress as well as depressive symptoms. The control group will receive treatment-as-usual. A total of 212 study participants will be included. A secondary study objective is to analyse associations of suboptimal glycaemic control, depressive symptoms and diabetes distress with inflammatory markers.

Conditions

• Diabetes Mellitus
• Affective Disorders
• Depression
• Depressive Symptoms
• Emotional Distress
• Diabetes Complications

Interventions

BEHAVIORAL

Diabetes-related affective problems analysis

Analysis of diabetes-related affective problems with regard to suboptimal glycaemic control

BEHAVIORAL

Goal setting towards improvement of glycaemic control

Discussing and setting goals regarding improvements of suboptimal glycaemic control, depressive symptoms and diabetes distress

BEHAVIORAL

Diabetes-specific problem-solving therapy

Diabetes-specific problem-solving therapy with main focus on suboptimal glycaemic control, depressive symptoms and diabetes distress

BEHAVIORAL

Interventions to increase diabetes treatment motivation

Interventions to increase diabetes treatment motivation in order to achieve improvements of glycaemic control as well as recovery from affective problems

BEHAVIORAL

Activation of personal and social resources

Activation of personal and social resources with a view to diabetes control and affective problems

BEHAVIORAL

Reduction of barriers to self-care/glycaemic control

Definition and reduction of barriers to adequate diabetes self-care behaviour as well as good glycaemic control

BEHAVIORAL

Cognitive restructuring of diabetes-related problems

Cognitive restructuring of diabetes-related problems such as suboptimal glycaemic control and diabetes-related affective problems

BEHAVIORAL

Goal definition regarding self-care/glycaemia/well-being

Goal definition and agreement regarding diabetes self-care behaviour, optimal glycaemic control and activities supporting well-being and recovery from affective symptoms

BEHAVIORAL

Health care and specific topics (e. g. blood pressure)

Education on health care and specific topics (e. g. blood pressure)

BEHAVIORAL

Healthy foods, cooking recommendations, recipes

Education on healthy and unhealthy foods, cooking and recipes

BEHAVIORAL

Sports, activities and exercise

Education on sports, activities and exercise

BEHAVIORAL

Foot care: exercises, care & control, injuries, neuropathy

Education on foot care: exercises, care and control, injuries, and diabetic neuropathy

BEHAVIORAL

Diabetes complications

Education on diabetes complications

BEHAVIORAL

Social aspects of living with diabetes

Education on social aspects of living with diabetes

Sponsors & Collaborators

• German Center for Diabetes Research

  collaborator OTHER

• Helmholtz Zentrum München

  collaborator INDUSTRY

• German Diabetes Center

  collaborator OTHER

• German Federal Ministry of Education and Research

  collaborator OTHER_GOV

• Forschungsinstitut der Diabetes Akademie Mergentheim

  lead OTHER

Principal Investigators

• Thomas Haak, Prof., MD · Diabetes Center Mergentheim

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

2015-07-01

Primary Completion

2018-03-31

Completion

2018-06-30

Countries

• Germany

Study Locations