Trial document




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  DRKS00011710

Trial Description

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Title

Depression and Diabetes Control Trial

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Trial Acronym

DDCT

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URL of the Trial

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Brief Summary in Lay Language

This research project aims at the development and evaluation of a structured intervention program for people with diabetes and suboptimal glycaemic control as well as elevated depressiveness and/or elevated diabetes-related distress. Therefore, a structured treatment program will be developed and compared to treatment-as-usual in a randomized, controlled trial by the Research Institute of the Diabetes-Academy Bad Mergentheim. A total of 212 participants should be included in the study. The primary outcome variable is glycaemic control, important secondary outcome variables are depressive Symptoms, diabetes-related distress, diabetes self-care, diabetes acceptance as well as quality of life. The evaluation analyses the superiority of specifical effects of the structured treatment program over treatment-as-usual regarding these variables. A secondary study objective is to analyse associations of suboptimal glycaemic control, depressive symptoms and diabetes distress with inflammatory markers.

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Brief Summary in Scientific Language

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. The primary hypothesis of the study is that participants treated with the cognitive-behavioral group program will show larger improvements regarding glycaemic control from baseline to 12-month follow-up than participants who received treatment as usual.
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.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00011710
  •   2017/02/09
  •   2016/02/02
  •   yes
  •   Approved
  •   F-2015-056#A1, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

  •   NCT02675257  (ClinicalTrials.gov)
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Health Condition or Problem studied

  •   E14 -  Unspecified diabetes mellitus
  •   F33.9 -  Recurrent depressive disorder, unspecified
  •   Suboptimal glycaemic control
  •   Diabetes-related distress
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Interventions/Observational Groups

  •   Experimental: 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
  •   Control: Treatment-as-usual

    Standard diabetes education in a tertiary setting
    - 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
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Improvement of glycaemic control as measured by the HbA1c [ Time Frame: 12 months ]
Mean difference between HbA1c values at baseline and at 12 month follow-up.

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Secondary Outcome

The respective difference between baseline and 12 Monats-Follow up between the two arms:

- Improvement of glycaemic control as measured by participants' blood glucose meter or glucose monitoring devices. Data are extracted from tools using the diasend application (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-up).
- Depressive symptoms (Epidemiologic Studies Depression Scale (CES-D), German version; Patient Health Question-naire [PHQ-9], German version)
- Diabetes-related distress (Problem Areas In Diabetes Scale [PAID], German version; Diabetes Distress Scale [DDS], German version)
- Diabetes self-care (Summary of Diabetes Self-Care Activities Measure [SDSCA],German version; Diabetes Self-Management Questionnaire [DSMQ])
- Diabetes acceptance (Diabetes Acceptance Scale [DAS])
- Emotional Well-being (WHO-Five Well-being Index [WHO-5], German version)
- Health-related quality of life (EuroQol Five Dimensions Questionnaire [EQ-5D], German version; Short Form-36 Health Survey [SF-36], German version)
- Inflammatory markers: hsCRP, IL-6, IL-18, IL-1Ra, MCP-1, Adiponectin

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2016/01/22
  •   212
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional 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

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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

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Addresses

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    • Forschungsinstitut der Diabetes-Akademie Bad Mergentheim
    • Johann-Hammer-Str. 24
    • 97980  Bad Mergentheim
    • Germany
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    • Deutsches Diabetes-Zentrum
    • Auf'm Hennekamp 65
    • 40225  Düsseldorf
    • Germany
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    • Forschungsinstitut der Diabetes-Akademie Bad Mergentheim
    • Mr.  Prof.  Bernhard  Kulzer 
    • Johann-Hammer-Straße 24
    • 97980  Bad Mergentheim
    • Germany
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    • Forschungsinstitut der Diabetes-Akademie Bad Mergentheim
    • Mr.  Prof.  Norbert  Hermanns 
    • Johann-Hammer-Straße 24
    • 97980  Bad Mergentheim
    • Germany
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    • Forschungsinstitut der Diabetes-Akademie Bad Mergentheim
    • Mr.  Prof.  Bernhard  Kulzer 
    • Johann-Hammer-Straße 24
    • 97980  Bad Mergentheim
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Zentrum für Diabetesforschung e.V.
    • Ingolstädter Landstrasse 1
    • 85764  Neuherberg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
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  •   2018/07/31
  •   213
  •   213
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Trial Publications, Results and other Documents

  •   Ethikvotum der Landesärztekammer Baden-Württemberg
  •   Prüfplan der DDCT-Studie (Version 1.1)
  •   Hermanns N, Schmitt A, Gahr A, Herder C, Nowotny B, Roden M, Ohmann C, Kruse J, Haak T, Kulzer B. (2015). The effect of a diabetes-specific cognitive behavioral treatment program (DIAMOS) for patients with diabetes and subclinical depression. Results of a randomized controlled trial. Diabetes Care. 38(4):551-560.
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