Study Results
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Basic Information
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COMPLETED
NA
213 participants
INTERVENTIONAL
2015-07-01
2018-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cognitive-behavioural group treatment
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
Diabetes-related affective problems analysis
Analysis of diabetes-related affective problems with regard to suboptimal glycaemic control
Goal setting towards improvement of glycaemic control
Discussing and setting goals regarding improvements of suboptimal glycaemic control, depressive symptoms and diabetes distress
Diabetes-specific problem-solving therapy
Diabetes-specific problem-solving therapy with main focus on suboptimal glycaemic control, depressive symptoms and diabetes distress
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
Activation of personal and social resources
Activation of personal and social resources with a view to diabetes control and affective problems
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
Cognitive restructuring of diabetes-related problems
Cognitive restructuring of diabetes-related problems such as suboptimal glycaemic control and diabetes-related affective problems
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
Treatment-as-usual
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
Health care and specific topics (e. g. blood pressure)
Education on health care and specific topics (e. g. blood pressure)
Healthy foods, cooking recommendations, recipes
Education on healthy and unhealthy foods, cooking and recipes
Sports, activities and exercise
Education on sports, activities and exercise
Foot care: exercises, care & control, injuries, neuropathy
Education on foot care: exercises, care and control, injuries, and diabetic neuropathy
Diabetes complications
Education on diabetes complications
Social aspects of living with diabetes
Education on social aspects of living with diabetes
Interventions
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Diabetes-related affective problems analysis
Analysis of diabetes-related affective problems with regard to suboptimal glycaemic control
Goal setting towards improvement of glycaemic control
Discussing and setting goals regarding improvements of suboptimal glycaemic control, depressive symptoms and diabetes distress
Diabetes-specific problem-solving therapy
Diabetes-specific problem-solving therapy with main focus on suboptimal glycaemic control, depressive symptoms and diabetes distress
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
Activation of personal and social resources
Activation of personal and social resources with a view to diabetes control and affective problems
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
Cognitive restructuring of diabetes-related problems
Cognitive restructuring of diabetes-related problems such as suboptimal glycaemic control and diabetes-related affective problems
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
Health care and specific topics (e. g. blood pressure)
Education on health care and specific topics (e. g. blood pressure)
Healthy foods, cooking recommendations, recipes
Education on healthy and unhealthy foods, cooking and recipes
Sports, activities and exercise
Education on sports, activities and exercise
Foot care: exercises, care & control, injuries, neuropathy
Education on foot care: exercises, care and control, injuries, and diabetic neuropathy
Diabetes complications
Education on diabetes complications
Social aspects of living with diabetes
Education on social aspects of living with diabetes
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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German Center for Diabetes Research
OTHER
Helmholtz Zentrum München
INDUSTRY
German Diabetes Center
OTHER
German Federal Ministry of Education and Research
OTHER_GOV
Forschungsinstitut der Diabetes Akademie Mergentheim
OTHER
Responsible Party
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Norbert Hermanns
Prof. Dr. phil. Norbert Hermanns
Principal Investigators
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Thomas Haak, Prof., MD
Role: PRINCIPAL_INVESTIGATOR
Diabetes Center Mergentheim
Locations
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Diabetes Center Mergentheim
Bad Mergentheim, Baden-Wurttemberg, Germany
Forschungsinstitut der Diabetes Akademie Mergentheim e. V.
Bad Mergentheim, Baden-Wurttemberg, Germany
Countries
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References
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Schmitt A, Ehrmann D, Kuniss N, Muller N, Kulzer B, Hermanns N. Assessing fear of complications in people with type 1 and type 2 diabetes with the Fear of Diabetes Complications Questionnaire. Health Psychol. 2023 Sep;42(9):674-685. doi: 10.1037/hea0001304. Epub 2023 Jul 27.
Other Identifiers
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FKZ 82DZD01101
Identifier Type: -
Identifier Source: org_study_id
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