Trial document




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  DRKS00005973

Trial Description

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Title

Internet-based training to treat subclinical depressive symptoms

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Trial Acronym

[---]*

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URL of the Trial

https://www.geton-training.de/DepressionPrevention.php

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Brief Summary in Lay Language

The online-training GET.ON Mood is aimed to reach people with mild to moderate depressive complaints who are searching for help but whose complaints do not require psychotherapy, yet. Major Depression is a severe disorder and the number of people suffering from Major Depression will further increase in the near future. In addition to the pain and suffering of the individual, costs to society are high. To treat people who suffer from mild to moderate depressive complaints with available face-to-face treatments would result in high individual costs. Internet-based programmes are probably cost-effective alternatives to existing face-to-face treatments. Studies showed that guided self-help programmes are effective in reducing depressive complaints. Pure self-help programmes were less effective. Preliminary results of a study evaluating a feedback-on-demand format to reduce work-related stress indicated that this format is as effective as guided self-help programmes. Feedback-on-demand means that an eCoach does not automatically writes a feedback but only in case a participant explicitly asks for it. Until now, it is not examined whether a feedback-on-demand format is also effective in reducing depressive complaints. The aim of the study is to enhance the evidence for internet-based programmes in the treatment of people who suffer from mild to moderate depressive complaints. Besides, the effectiveness of a feedback-on-demand format will be examined. It is expected that participants in the intervention group report significant less about depressive complaints at post-treatment than participants in the waiting list control condition who have unrestricted access to care-as-usual. It is expected that the effects are still significant three months after group allocation.

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Brief Summary in Scientific Language

Subclinical depression is a highly prevalent condition and is associated with reduced quality of life and high costs for society. Costs are mainly caused by productivity losses. Moreover, as part of the prodromal stage subclinical depressive symptoms are a risk factor for major depression (MDD). Subclinical depression means that depressive symptoms are present but these do not fulfil the diagnostic criteria of a MDD according to, i.e., DSM-IV criteria. Treating subclinical depression with evidence-based face-to-face treatments would lead to high medical costs at individual level. Internet-based interventions based on cognitive-behavioural therapy are probably a cost-effective approach to treating subclinical depression. Studies showed that guided-self help interventions are effective in reducing depressive symptoms. Less expensive pure self-help programmes were less effective. Preliminary results of a study evaluating a feedback-on-demand format to reduce work-related stress indicated that this format is as effective as guided self-help programmes. Feedback-on-demand means that an eCoach does not automatically writes a feedback but only if a participant explicitly asks for it. Until now, it is not examined whether a feedback-on-demand format is also effective in reducing subclinical depressive symptoms.
The aim of the study is to enhance the evidence for internet-based interventions in the treatment of subclinical depression and to examine the effectiveness of a feedback-on-demand format in the treatment of subclinical depression. It is expected that participants in the intervention group report significant less depressive symptoms at post-treatment than participants in the waiting list control condition who have unrestricted access to care-as-usual. It is expected that the effects are still significant three months after randomisation.

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Organizational Data

  •   DRKS00005973
  •   2014/07/01
  •   [---]*
  •   yes
  •   Approved
  •   2014-04 Ebert, Ethikbeirat der Leuphana Universität Lüneburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   subclinical depression
  •   F32.0 -  Mild depressive episode
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Interventions/Observational Groups

  •   Interactive 6-weeks self-help training (GET.ON Mood) with 6 lessons that focus on psychoeducation, behavioural activation, and problem-solving. A booster session 4 weeks after completion of the 6th lesson is also offered. Additionally, 3 elective modules (better sleep, less worrying, relaxation) are offered. Participants are also asked to keep a mood- and activity diary. Participants can ask an eCoach to write a feedback about a session or specific exercises. Participants receive the feedback on workdays within 48 hours. ECoaches are psychotherapists in training. The eCoach also checks whether participants work through the trainings as planned (1 session a week). The eCoach reinforces participants if they did so. If participants did not finish a session, the eCoach will send out a reminder. Participants are not blinded to treatment condition meaning that they know whether they are in the intervention (GET.ON Mood) or control group (waitlist).
  •   Waitlist control group (3 months)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

- depressive symptoms self-report: (CES-D, GIDS): baseline, post (7 weeks), 3 months + observer-rated (HDRS/QIDS): baseline and post (7 weeks)

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Secondary Outcome


- quality of life (AQoL): baseline, post, 3 months
- Symptoms of anxiety (HADS, anxiety subscale): baseline, post, 3 months
-problem-solving (social problem-solving inventory, short version): baseline, post, 3 months
- behavioural activation (behavioural activation depression scale, BADS): baseline, post, 3 months
- Worrying (Penn State-Worrying-Questionnaire, PSQW, short version): baseline, post, 3 months
- Insomnia Severity, Insomnia Severity Index (ISI): baseline, post, 3 month
- Mastery (Pearlin & Schooler Mastery Scale): baseline, post, 3 months
- Treatment credibility/participants' expectancy (Treatment credibility/patient expectancy questionnaire, CEQ): baseline and post
- alcohol consumption (AUDIT): baseline, post, 3 months
- participants' satisfaction (participants' satisfaction questionnaire): post
- Attitudes towards psychological help: baseline, post, 3 months
- motivation (HAPA): baseline
- side-effects of psychotherapy (INEP): post and 3 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2014/07/01
  •   204
  •   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

-18 years of age
-depressive symptoms (CES-D equal or greater to 16)
- internet access
- valid email address

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Exclusion Criteria

- Acute major depressive episode, psychotic symptomatology, bipolar disorder
- Major depressive episode, psychotic symptomatology, bipolar disorder in the past six months
- Current psychotherapy
- Being on a waiting list for psychotherapy
- Psychotherpay in the past six months
- Suicidal risk (BDI item 9 > 1)

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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
    • Ms.  M.Phil  Claudia  Buntrock 
    • Rotenbleicher Weg 67
    • 21335  Lüneburg
    • Germany
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    • Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
    • Ms.  M.Phil  Claudia  Buntrock 
    • Rotenbleicher Weg 67
    • 21335  Lüneburg
    • Germany
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Sources of Monetary or Material Support

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    • Investitions-und Förderungsbank Niedersachsen (NBank)
    • Günther-Wagner-Allee 12-16
    • 30177  Hannover
    • Germany
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    • BARMER GEK
    • Lichtscheider Str 89
    • 42285  Wuppertal
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • European Union
    • 1000  Brüssel
    • Belgium
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Status

  •   Recruiting complete, follow-up complete
  •   2015/03/03
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Trial Publications, Results and other Documents

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