Trial document




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  DRKS00011312

Trial Description

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Title

Effect of a specific self management training program for patients with type 2 diabetes and depression

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Trial Acronym

Sante

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Type 2 diabetics’ risk of developing depression is twice as high. They also have a lower blood sugar control an increased risk for complications, overweight and a reduced quality of life. Routinely, structured diabetic training is offered as part of diabetic therapy. To date, there are no training programs exclusively for patients with Type 2 diabetes and depression. Thus, the question arises whether diabetic training including elements of problem solving training is superior to standard treatment. Such training shall be derived from existing programs and will be examined in this study. Success of our training, feasibility and patient's acceptance has been investigated. Also, changes in HbA1c and depressive will be analyzed.

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Brief Summary in Scientific Language

Objective: To date, there are no specialized structured diabetic training programs for patients with type 2 diabetes and comorbid depression. Effective treatment of both diseases is essential. Since structured diabetic training programs are basic treatment suggested by national provision guideline for patients with type 2 diabetes and since there is good evidence of the effectiveness of problem solving this pilot study will analyze whether a training program including specific elements of problem solving is better than standard diabetic training for patients with type 2 diabetes and comorbid depression regarding training success, feasibility and acceptance.
Design: monocentric, randomized controlled trial
Intervention: Patients with diabetes mellitus type 2 and comorbid mild to moderate depression will receive a specific training program including problem solving elements (1 session of 90 minutes per week for 12 weeks in a group consisting of 4-8 people).
Participants: People with diabetes mellitus type 2 and comorbid mild to moderate depression who are recruited by Department of Endocrinology / Diabetology of University Hospital Freiburg and by Diabetes Network Breisgau e.V.
Data collection: Baseline, after training program (12 weeks) and 3 months after end of training (follow-up)

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Organizational Data

  •   DRKS00011312
  •   2017/01/19
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  •   yes
  •   Approved
  •   174/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   E11 -  Type 2 diabetes mellitus
  •   F32.0 -  Mild depressive episode
  •   F32.1 -  Moderate depressive episode
  •   F33.0 -  Recurrent depressive disorder, current episode mild
  •   F33.1 -  Recurrent depressive disorder, current episode moderate
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Interventions/Observational Groups

  •   specific training program including problem solving elements (1 session of 90 minutes per week for 12 weeks in a group consisting of 4-8 people).
  •   Standard training program (MEDIAS-2 BASIS) (1 session of 90 minutes per week for 12 weeks in a group consisting of 4-8 people).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Knowledge of diabetes, measured with Diabetes Knowledge Questionnaire (DKQ)
T0 - T1 - T2
(Baseline – After finishing the training program (12 weeks) - Follow-Up (3 months after finishing the training program)

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Secondary Outcome

Diabetic metabolic situation, measured with HbA1c (T0 – T1 – T2)
Diabetes related quality of life, measured with Problem Areas in Diabetes Scale (PAID) (T0 – T1 – T2)
Depression, measured with PHQ-9 (T0 - T1- T2)
Problem solving skills, measured with Social Problem-Solving Inventory-Revised Short Version (SPSI-R-S) (T0 - T1)
Self-Management, measured with Diabetes Self-Management Questionnaire (DSMQ) (T0 - T1 - T2)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/12/20
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Diabetes mellitus Type 2
HbA1c > 7% and ≤ 10,5%
Stable antidiabetic medication for more than 3 months
Mild to moderate depression (ICD)
Sufficient knowledge of German language

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Exclusion Criteria

Anamnesis of psychotic symptoms, bipolar disorders, organic brain diseases, diagnosis of other Axis-I-disorders
Ongoing psychotherapy or psychiatric treatment
Terminal illness
Therapy with short time Insulin (SIT or ICT)
Diabetes mellitus Type 1
blood sugar imbalances, which require therapy intensification to avoid acute complications (e.g. hyperglycaemic Coma)
Fasting blood glucose ≥ 270 mg/dl

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Addresses

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    • Universitätsklinikum FreiburgAbteilung Endokrinologie und Diabetologie
    • Ms.  Dr. med.  Katharina  Laubner 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgAG Psychotherapie- und Versorgungsforschung
    • Mr.  Dr. phil  Lars  Hölzel 
    • Hauptstraße 5
    • 79104  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgAbteilung Endokrinologie und Diabetologie
    • Ms.  Dr. med.  Katharina  Laubner 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Ms.  Lyn Anne  von Zepelin 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Nachwuchsakademie Versorgungsforschung Baden-Württemberg, Abteilung Allgemeinmedizin & Versorgungsforschung
    • Voßstr.2, Geb. 37
    • 69115  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.