NCT02675257: DDCT

Depression and Diabetes Control Trial

Completed NA Last updated 28 August 2018

What this trial tests

NA trial testing Diabetes-related affective problems analysis in Diabetes Mellitus in 213 participants. Completed in 30 June 2018.

Timeline

1 July 2015

Primary endpoint
31 March 2018

30 June 2018

Quick facts

Lead sponsor	Forschungsinstitut der Diabetes Akademie Mergentheim
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	213
Start date	1 July 2015
Primary completion	31 March 2018
Estimated completion	30 June 2018
Sites	2 locations across Germany

Drugs / interventions tested

• Diabetes-related affective problems analysis
• Goal setting towards improvement of glycaemic control
• Diabetes-specific problem-solving therapy
• Interventions to increase diabetes treatment motivation
• Activation of personal and social resources
• Reduction of barriers to self-care/glycaemic control
• Cognitive restructuring of diabetes-related problems
• Goal definition regarding self-care/glycaemia/well-being
• Health care and specific topics (e. g. blood pressure)
• Healthy foods, cooking recommendations, recipes
• Sports, activities and exercise
• Foot care: exercises, care & control, injuries, neuropathy
• Diabetes complications
• Social aspects of living with diabetes

Conditions studied

• Diabetes Mellitus — all drugs for Diabetes Mellitus →
• Affective Disorders — all drugs for Affective Disorders →
• Depression — all drugs for Depression →
• Depressive Symptoms — all drugs for Depressive Symptoms →

Sponsor

Forschungsinstitut der Diabetes Akademie Mergentheim

Who can join

Adults 18 to 70, any sex, with Diabetes Mellitus or Affective Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Psychological interventions for diabetes-related distress in adults with type 2 diabetes mellitus.
   Chew BH, Vos RC, Metzendorf MI, Scholten RJ, et al · · 2017 · cited 77× · PMID 28954185 · DOI 10.1002/14651858.cd011469.pub2
2. A Self-Report Measure of Diabetes Self-Management for Type 1 and Type 2 Diabetes: The Diabetes Self-Management Questionnaire-Revised (DSMQ-R) - Clinimetric Evidence From Five Studies.
   Schmitt A, Kulzer B, Ehrmann D, Haak T, et al · · 2021 · cited 33× · PMID 36994332 · DOI 10.3389/fcdhc.2021.823046
3. Associations between biomarkers of inflammation and depressive symptoms-potential differences between diabetes types and symptom clusters of depression.
   Herder C, Zhu A, Schmitt A, Spagnuolo MC, et al · · 2025 · cited 11× · PMID 39799156 · DOI 10.1038/s41398-024-03209-y
4. Biomarkers of inflammation and improvement in depressive symptoms in type 1 and type 2 diabetes: differential associations with depressive symptom clusters.
   Herder C, Zhu A, Schmitt A, Spagnuolo MC, et al · · 2025 · PMID 40624224 · DOI 10.1007/s00125-025-06472-w