Depression and Diabetes Control Trial (DDCT)

Forschungsinstitut der Diabetes Akademie Mergentheim

Status: Completed

Conditions: Depressive Symptoms; Diabetes Complications; Diabetes Mellitus; Emotional Distress; Depression; Affective Disorders

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02675257

FKZ 82DZD01101

Details and patient eligibility

About

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.

Full description

Suboptimal glycaemic control is an established risk factor for the development of serious long-term complications of diabetes. Moreover, it is associated with elevated risks of significant hyperglycaemic acute events such as hyperosmolar hyperglycemic state or diabetic ketoacidosis. Hence, patients with diabetes and persistent suboptimal glycaemic control are at higher risk of having a rather poor prognosis.

Besides physiological and medical factors, psychological problems have been found to predict suboptimal glycaemic control. A number of studies found depressive symptoms to be independently associated with hyperglycaemia. Others focussed on diabetes-specific affective problems - the so called diabetes distress - and suggested this factor to be of great importance. Finally, some studies found that depressive symptoms and diabetes distress may interact, with the coocurrence of these factors being associated with the highest risk or suboptimal glycaemic control. The results correspond to other findings suggesting that both depressive symptoms and diabetes distress are often associated with reduced diabetes self-care, which can explain the associations of those factors with hyperglycaemia.

On the other hand, suboptimal glycaemic control could also be an explanation for affective problems - either mediated by physiological mechanisms or psychological ones, e.g. dissatisfaction or guilt. Hence, it is valid to assume that the link between depressive symptoms and/or diabetes distress may be bidirectional - although evidence to support this assumption is missing.

Following this evidence and background, the investigators designed the a to analyse the relationships between suboptimal glycaemic control, depressive symptoms and diabetes distress in diabetes using a prospective study design. The study is a randomized trial in which a cognitive-behavioural group treatment is compared to a treatment-as-usual condition (standard diabetes education) regarding their efficacy in improving suboptimal glycaemic control. 212 diabetes patients with suboptimal glycaemic control (HbA1c value > 7.5%) and elevated depressive symptoms (Center for Epidemiologic Studies Depressions Scale score ≥ 16) and/or elevated diabetes distress (Problem Areas In Diabetes Scale score ≥ 40) will be randomly assigned to either the treatment group or treatment-as-usual. The primary outcome is the improvement of suboptimal glycaemic control (reduction of HbA1c) in the 12-month follow-up. As secondary outcomes positive baseline-to-follow up changes regarding depressive symptoms, diabetes distress, diabetes self-care behaviour, diabetes acceptance and quality of life are assessed.

A second study objective is to analyse cross-sectional and prospective associations of suboptimal glycaemic control, depressive symptoms and diabetes distress with serum levels of the following inflammatory markers: hsCRP, IL-6, IL-18, IL-1Ra, MCP-1 and Adiponectin. Potential effects of the treatment groups on these markers will also be examined.

Enrollment: 213 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 70
• Diabetes mellitus type 1 or type 2
• Diabetes duration ≥ 1 year
• Suboptimal glycaemic control (HbA1c > 7,5%)
• Elevated depressive symptoms (CES-D score ≥ 16) and/or elevated diabetes distress (PAID score ≥ 40)
• Sufficient language skills
• Written informed consent

Exclusion criteria

• Severe major depressive disorder according to ICD-10
• Current psychiatric and/or psychotherapeutic treatment
• Current antidepressive medical treatment
• Suicidal ideation
• Acute mental disorder of the following type: schizophrenia or other psychotic disorder, bipolar disorder, severe eating disorder (anorexia nervosa, bulimia nervosa), substance use disorder
• History of personality disorder
• Severe somatic illnesses: dialysis-dependent nephropathy, acute cancer, severe heart disease (NYHA III - IV), severe neurologic illness (e. g. MS, dementia), severe autoimmune disease
• Terminal illness
• Bedriddenness
• Guardianship

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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213 participants in 2 patient groups

Cognitive-behavioural group treatment

Experimental group

Description:

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

Treatment:

Behavioral: Interventions to increase diabetes treatment motivation

Behavioral: Reduction of barriers to self-care/glycaemic control

Behavioral: Activation of personal and social resources

Behavioral: Diabetes-related affective problems analysis

Behavioral: Goal setting towards improvement of glycaemic control

Behavioral: Diabetes-specific problem-solving therapy

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

Behavioral: Cognitive restructuring of diabetes-related problems

Treatment-as-usual

Active Comparator group

Description:

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

Treatment:

Behavioral: Sports, activities and exercise

Behavioral: Social aspects of living with diabetes

Behavioral: Diabetes complications

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

Behavioral: Healthy foods, cooking recommendations, recipes

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