Trial document




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  DRKS00005025

Trial Description

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Title

Online Training To Overcome Depression

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Trial Acronym

GET.ON MD

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URL of the Trial

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Brief Summary in Lay Language

Major depression is a common and severe disorder. There are effective treatments available. Although not everyone who suffers from depression makes use of one of these services. Reasons often may be a lack of time and a lack of motivation as well as a fear of stigmatization. Internet-based training programs may be helpful to overcome these barriers, because participants remain anonym and can use the training program whenever they want.
The online-training GET.ON depression aims to reach people concerned depressive symptoms, who search for support but do not get psychotherapy due to a long waiting time or because of other reasons mentioned above.
In this study people with depression disorder will be randomly assigned into one of two groups. The training group participates in the GET.ON depression program while the reference group receives information about depression and its treatment possibilities. The aim of this study is to examine the reduction of depressive symptoms of the training group compared to the reference group.

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Brief Summary in Scientific Language

Evidence exists that internet-based interventions are effective in reducing depressive symptoms. Scientific studies have proven that psychoeducational-only interventions are also effective to reduce depressive symptoms. Hence, this study aims to evaluate the efficacy of an internet-based training program (GET.ON MD) for people with considerably depressive symptoms in comparison to psychoeducation-only control. In a randomized-controlled trial people (N=128) with major depression (assessed via SCID I) will be randomly allocated to one of two treatment groups (A or B) and assessed after 6 weeks and after 12 weeks. People of group A participate in the training program GET.ON MD. The training consists of 6 sessions and includes psychoeducational, behavioral activation and problem solving elements and a written feedback after each session by an online-coach. Participants of group B get access to an online-psychoeducational manual which is based on the Patientenleitlinie zur Nationalen VersorgungsLeitlinie Unipolare Depression (German clinical guideline for depression). The manual contains information about depressive symptoms, health care services and self-help for depression.
Primary outcome is the reduction in depressive symptoms.

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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

  •   DRKS00005025
  •   2013/06/06
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  •   yes
  •   Approved
  •   2013-08K, Ethik-Kommission des Fachbereichs Psychologie an der Philipps-Universität Marburg
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Secondary IDs

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Health Condition or Problem studied

  •   F32 -  Depressive episode
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Interventions/Observational Groups

  •   Treatment group A (guided online-training):
    Interactive three weeks self-help program (Get.On MD) with 6 sessions, which focuses on psychoeducation, problemsolving and behavioral activation; after finishing each session participants receive an individualised feedback, written by an online coach. Furthermore patients are asked to write a mood diary. Between the sessions the participants have the chance to integrate different techniques into their daily routines.
  •   Treatment group B (Information only):
    Participants get access to an online-psychoeducational manual without any guidance by an online coach.
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Characteristics

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

Severity of depressive symptoms (observer rated), measured with the Quick Inventory of Depressive Symptomatology (QIDS, Rush, 2003) and the Hamilton Rating Scale for Depression (HRSD, Hamilton, 1960/67) before treatment (baseline=pre) and after treatment (6 weeks=post)

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Secondary Outcome

- course of depressive symptoms (Patient-Health-Questionnaire, PHQ-9): pre, post, follow up (12 weeks)
- activity level (Behavioural Activation Depression Scale, BA-DS, short version): pre, post, follow up
- anxiety symptoms (Hospital Anxiety and Depression Scale, HADS, anxiety subscale): pre, post, follow up
- problem solving (Social Problem Solving Inventory): pre, post, follow up
- attitudes towards seeking professional help (ATSPH-Scale): pre, post
- general health (Health Survey – Short Form, SF-12): pre, post, follow up
- well being (WHO Five Well-being Index): pre, post, follow-up
- side effects of psychotherapy (Inventar zur Erfassung negativer Effekte von Psychotherapie, INEP): post
- training satisfaction (Client Satisfaction Questionnaire, CSQ-8): post

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2013/05/21
  •   128
  •   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

- access to Internet and e-mail
- diagnose of depressive episode (via SCID)

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Exclusion Criteria

- acute psychotic symptoms (at baseline)
- current or former manic/hypomanic episode
- former diagnose of psychosis/schizophrenia
- suicide risk (score of BDI-II item 9 > 1)
- receiving psychotherapy
- changed medication against depression within 4 weeks before baseline

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Addresses

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    • Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
    • Mr.  David  Ebert 
    • Rotenbleicher Weg 67
    • 21335  Lüneburg
    • Germany
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    • Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
    • Mr.  Leif  Boß 
    • Rotenbleicher Weg 67
    • 21335  Lüneburg
    • Germany
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    • Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
    • Mr.  Leif  Boß 
    • Rotenbleicher Weg 67
    • 21335  Lüneburg
    • Germany
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Sources of Monetary or Material Support

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    • European Union
    • 1000  Brüssel
    • Belgium
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Status

  •   Recruiting complete, follow-up complete
  •   2014/07/11
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Trial Publications, Results and other Documents

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