Depression and Diabetes Control Trial

Not Applicable

Completed

• Conditions: Affective Disorders; Depressive Symptoms; Diabetes Mellitus; Depression; Emotional Distress; Diabetes Complications
• Interventions: Behavioral: Health care and specific topics (e. g. blood pressure); Behavioral: Diabetes-related affective problems analysis; Behavioral: Goal setting towards improvement of glycaemic control; Behavioral: Healthy foods, cooking recommendations, recipes; Behavioral: Diabetes-specific problem-solving therapy; Behavioral: Sports, activities and exercise; Behavioral: Interventions to increase diabetes treatment motivation; Behavioral: Diabetes complications; Behavioral: Social aspects of living with diabetes; Behavioral: Activation of personal and social resources; Behavioral: Reduction of barriers to self-care/glycaemic control; Behavioral: Cognitive restructuring of diabetes-related problems; Behavioral: Goal definition regarding self-care/glycaemia/well-being

• Registration Number: NCT02675257
• Lead Sponsor: Forschungsinstitut der Diabetes Akademie Mergentheim

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.

Detailed 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.

Study Timeline

• Study Start: 2015-07-01
• Study First Submitted: 2016-02-02
• Study First Submitted QC: 2016-02-04
• Study First Posted: 2016-02-05
• Primary Completion: 2018-03-31
• Study Completion: 2018-06-30
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Improvement of diabetes acceptance as measured with the Diabetes Acceptance Scale (DAS)	12 months	Mean difference between DAS scores at baseline and at 12 month follow
Improvement of quality of life as measured with the EuroQol Five-Dimensions Questionnaire (EQ-5D)	12 months	Mean difference between EQ-5D scores at baseline and at 12 month follow
Improvement of depressive symptoms as measured with the Patient Health Questionnaire Module for Depression (PHQ-9)	12 months	Mean difference between PHQ-9 scores at baseline and at 12 month follow up
IImprovement of diabetes distress as measured with the Problem Areas in Diabetes Scale (PAID)	12 months	Mean difference between PAID scores at baseline and at 12 month follow
Improvement of self-care behaviour as measured with the Summary of Diabetes Self-Care Activities Measure (SDSCA)	12 months	Mean difference between SDSCA scores at baseline and at 12 month follow
Improvement of self-care behaviour as measured with the Diabetes Self-Management Questionnaire (DSMQ)	12 months	Mean difference between DSMQ scores at baseline and at 12 month follow
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	Mean difference between average glucose test scores during an 8-week period before baseline and those during an 8-week period before 12 month follow
Improvement of depressive symptoms as measured with the Center for Epidemiologic Studies Depression Scale (CES-D)	12 months	Mean difference between CES-D scores at baseline and at 12 month follow up
IImprovement of diabetes distress as measured with the Diabetes Distress Scale (DDS)	12 months	Mean difference between DDS scores at baseline and at 12 month follow
Improvement of quality of life as measured with the Short Form-36 Health Survey (SF-36)	12 months	Mean difference between SF-36 scores at baseline and at 12 month follow

Trial Locations

Locations (2)

Diabetes Center Mergentheim; 🇩🇪 Bad Mergentheim, BW, Germany

Forschungsinstitut der Diabetes Akademie Mergentheim e. V.; 🇩🇪 Bad Mergentheim, Baden-Württemberg, Germany