Trial document




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  DRKS00004748

Trial Description

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Title

Internet-based programme to treat depressive symptoms of patients with diabetes mellitus type 1 and type 2

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Trial Acronym

[---]*

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URL of the Trial

http://www.geton-training.de/Diabetes.php

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Brief Summary in Lay Language

People with diabetes suffer twice as often from depressive symptoms compared to the general population. At the Leuphana University Lüneburg, we developed an online program for people with diabetes (type 1 and type 2) and depressive symptoms. Study participants will be randomly assigned to one of two groups. One group (intervention group) gets access to the online training. The training focuses on the promotion of the participants own skills in dealing with crises and stress of everyday life.
For instance, participants learn:
• how to re-experience more joy in their life and how to overcome a state of exhaustion
• how to solve problems on a fixed schedule
• how to reduce worry and rumination
• how to improve the handling of the diabetes.
The special benefit of this training is that it was in particular developed for people with diabetes and therefore it also addresses all relevant aspects of diabetes.

The other group (control group) receives materials about depression.

The aim of the study is to prove whether an online program can effectively help people with diabetes mellitus (type 1 or type 2) to reduce depressive symptoms.

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Brief Summary in Scientific Language

Between 10% and 20% of the diabetic patients (type 1 and type 2) suffer from depressive symptoms. Every fifth patient has subclinical depressive symptoms. Diabetes in combination with depression is associated with poor diabetic self-care, impairment of glycemic control and higher risks of diabetes-related complications.

Internet-based interventions are a promising approach, since it has been proven to be effective of reducing depressive symptoms. The aim of this study is to evaluate whether a mobile phone-based diabetes-specific internet-based intervention can reduce depressive symptoms.


This study is a randomized controlled trial (N=260). Participants will be randomly allocated to one of the two groups: the intervention group (access to the online program) or the control group (provided with materials for psychoeducation). Participants of both groups will have unrestricted access to professional care, if needed.
This study aims at testing the effectiveness of an internet-based intervention (guided self-help; weekly contact via e-mail). Furthermore, in an additional analysis the focus lies on the cost-effectiveness.
The primary outcome is the reduction of depressive symptoms, measured by the General Depression Scale (ADS).
Secondary outcomes are amongst others diabetes-specific emotional distress, glycemic control, quality of life and the health care costs.
For both groups, cost and outcome measures will be taken at baseline and at the end of the intervention (after 8 weeks). Moreover, there will be follow-ups at 6 and 12 months after baseline via online-questionnaires.

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Organizational Data

  •   DRKS00004748
  •   2013/02/25
  •   [---]*
  •   yes
  •   Approved
  •   2012 -45K, Marburg-Ethikkommission des Fachbereichs Psychologie der Philipps Universität Marburg
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Secondary IDs

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Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
  •   E10 -  Insulin-dependent diabetes mellitus
  •   E11 -  Non-insulin-dependent diabetes mellitus
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Interventions/Observational Groups

  •   The intervention group (N= 130) undergoes a six-week online training (6 lessons, one lesson per week,one lesson takes about 45 minutes) with supportive emails (guided self-help) and (optional) supporting SMS. Four weeks after the final lesson, a 7th lesson takes place. Half of the random sample (N total=260; N path1=130) is randomized in this path. This group gets access to the online program "Get.On diabetes and depressive symptoms." The training was especially developed for participants with diabetes (type 1 and type 2) and depressive symptoms. The aim is to reduce depressive symptoms and to enhance diabetes self-management skills.
  •   The control group (N = 130) receives materials for psychoeducation in the field of depression. After the last measurement point (12 months) the control group will get access to the online training.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Depressive symptoms, measured though the Center for Epidemiological Studies Depression Scale (CES-D): Pre, Post, 6 and 12 months-follow-up

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Secondary Outcome

- Demographic questionnaire: Pre
-Worry (Penn State-Worry-Questionnaire, PSWQ, short version): Pre, Post, 6 and 12 months-follow-up
- Activation (Behavioural Activation Depression Scale, BA-DS, short version): Pre, Post, 6 and 12 months-follow-up
- Problem solving (Social Problem Solving Inventory, short version): Pre, Post, 6 and 12 months-follow-up
- Long-term blood sugar level (HbA1c-value): Pre, 6 and 12 months-follow-up
- Problem areas in diabetes (PAID, short version): Pre, Post, 6 and 12 months-follow-up
- Acceptance and Action Diabetes Questionnaire (AADQ, German version): Pre, Post, 6 and 12 months-follow-up
- Diabetes Self-Management Questionnaire (DSMQ): Pre, Post, 6 and 12 months-follow-up
- Depression (HADS-D): Pre, Post, 6 and 12 months-follow-up
- Patient Questionnaire on Therapy Expectation and Evaluation (Pathev): Pre (intervention group only)
- Negative effects of online health trainings (based on INEP): Post (intervention group only)
- attitude toward seeking professional help scale (ATSPHS): Pre, Post
- Satisfaction with the program (adaption ZUF-8): Post (intervention group only)
- Life quality (EuroQol): Pre, Post, 6 and 12 month-follow-up
- Life quality (SF-12): Pre, Post, 6 and 12 month-follow-up
- questionnaire for costs associated with psychiatric Illness (German adaption of Trimbos/iMTA questionnaire for costs associated with psychiatric Illness (TiC-P)): Pre, 6 and 12 month-follow-up

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2013/03/01
  •   260
  •   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

depressive symptoms (Allgemeine Depressionsskala >22),
diabetes mellitus type 1 or type 2 (diagnosed more than 3 months prior to the study), German language skills, access to the internet, email address

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Exclusion Criteria

at baseline slight suicidality, measured by the item 9 of the BDI II (value> 1) and measured through the SCID, currently in psychotherapeutic treatment or on a waiting list for such treatment, pregnancy, unwilling to sign the consent form

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Addresses

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    • Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
    • Mr.  Dr.  Dirk  Lehr 
    • Rotenbleicher Weg 67
    • 21335  Lüneburg
    • Germany
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    • Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online /Innovations-Inkubator
    • Ms.  M.A.  Stephanie  Nobis 
    • Rotenbleicher Weg 67
    • 21335  Lüneburg
    • Germany
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    • Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online /Innovations-Inkubator
    • Ms.  M.A.  Stephanie  Nobis 
    • Rotenbleicher Weg 67
    • 21335  Lüneburg
    • Germany
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Sources of Monetary or Material Support

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    • European Union (finanzielle Förderung organisiert über NBank bzw. Niedersächsisches Ministerium für Wirtschaft, Arbeit und Verkehr)
    • Friedrichswall 1
    • 30159  Hannover
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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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.