Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

213

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline

Completed

Started Jul 2015

Typical duration for not_applicable diabetes-mellitus

Geographic Reach

1 country

2 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3 years study duration

Study Start

First participant enrolled

July 1, 2015

Completed

7 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2016

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed

Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

2.8 years

First QC Date

February 2, 2016

Last Update Submit

August 27, 2018

Conditions

Diabetes Mellitus Affective Disorders Depression Depressive Symptoms Emotional Distress Diabetes Complications

Keywords

Diabetes mellitusAffective disordersDepressive symptomsDiabetes distressHyperglycaemiaDysglycaemiaGlycaemic controlSelf-care behaviourQuality of LifeDiabetes acceptanceDiabetes complicationsLow-grade inflammationInflammatory markersStress reactivityHealth-care costs

Outcome Measures

Primary Outcomes (1)

Improvement of glycaemic control as measured by the HbA1c
Mean difference between HbA1c values at baseline and at 12 month follow
12 months

Secondary Outcomes (10)

Improvement of glycaemic control as measured by participants' blood glucose meter or glucose monitoring devices (data are extracted from tools using the diasend application)
12 months
Improvement of depressive symptoms as measured with the Center for Epidemiologic Studies Depression Scale (CES-D)
12 months
Improvement of depressive symptoms as measured with the Patient Health Questionnaire Module for Depression (PHQ-9)
12 months
IImprovement of diabetes distress as measured with the Problem Areas in Diabetes Scale (PAID)
12 months
IImprovement of diabetes distress as measured with the Diabetes Distress Scale (DDS)
12 months
+5 more secondary outcomes

Other Outcomes (6)

Inflammatory Marker: hsCRP
12 months
Inflammatory Marker: IL-6
12 months
Inflammatory Marker: IL-18
12 months
+3 more other outcomes

Study Arms (2)

Cognitive-behavioural group treatment

EXPERIMENTAL

Five group sessions of diabetes-Specific cognitive-behavioural group treatment for diabetes patients with depressive symptoms and/or diabetes distress and suboptimal glycaemic control. Interventions: * 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

Behavioral: Diabetes-related affective problems analysisBehavioral: Goal setting towards improvement of glycaemic controlBehavioral: Diabetes-specific problem-solving therapyBehavioral: Interventions to increase diabetes treatment motivationBehavioral: Activation of personal and social resourcesBehavioral: Reduction of barriers to self-care/glycaemic controlBehavioral: Cognitive restructuring of diabetes-related problemsBehavioral: Goal definition regarding self-care/glycaemia/well-being

Treatment-as-usual

ACTIVE COMPARATOR

Standard diabetes education. Interventions: * 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

Behavioral: Health care and specific topics (e. g. blood pressure)Behavioral: Healthy foods, cooking recommendations, recipesBehavioral: Sports, activities and exerciseBehavioral: Foot care: exercises, care & control, injuries, neuropathyBehavioral: Diabetes complicationsBehavioral: Social aspects of living with diabetes