Trial document
DRKS00004709
Trial Description
Title
Internet-based prevention of Major Depression
Trial Acronym
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URL of the Trial
https://www.geton-training.de/DepressionPrevention.php
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, economic costs are tremendous. Prevention as a supplement to ordinary treatment has been assumed to play a crucial role in decreasing the enormous burden of this disease. Preventive face-to-face courses have already been found to be effective. The risk that people with mild to moderate depressive complaints develop a full-blown depression is reduced when they take part in such preventive courses. But people do not make use of these services. A lack of time and motivation, as well as reluctance of searching help due to a fear of stigmatization, are just some reasons why people do not participate in face-to-face courses. Internet-based trainings might help to overcome these barriers because people can stay anonymous and can access the trainings whenever they want to. Furthermore, these interventions require less therapeutic resources. Thus, health care costs might be reduced.
The aim of this study is to examine whether the online-training GET.ON Mood is effective in reducing the number of people developing a full-blown depression among people who have mild to moderate depressive complaints. In addition, the online-based treatment might generally lighten depressive symptoms and anxious feelings and change quality of life for the better.
Brief Summary in Scientific Language
Major depressive disorder (MDD) is projected to be the leading cause of premature mortality and disability by 2030. MDD is associated with a considerable loss of quality of life, increased mortality rates, and enormous economic costs. Prevention is suggested as an adjunct to treatment that may contribute to reducing the enormous burden of MDD. Preventive f2f interventions are proven to be effective in reducing the incidence of MDD. Low participation rates and high costs of comprehensive implementation, however, require new approaches to depression prevention going beyond the limits of traditional f2f interventions. Online interventions may attract people not making use of traditional services as well as they may cut costs. However, while Internet-based interventions are effective in reducing depressive symptoms, less is known about their potential to prevent the onset of MDD. Therefore, the aim of this study is to evaluate the (cost-) effectiveness of a guided Internet-based intervention on the onset of MDD in participants with subthreshold depression.
We will conduct a randomised controlled trial (RCT) to compare the (cost-) effectiveness of the GET.ON Mood training with a psychoeducation-only control. Adults with subthreshold depression (N=406) will be recruited and randomised to one of the two conditions with follow-ups at post-treatment, 6, and 12 months. The primary outcome is time to onset of MDD assessed within a 12- months follow-up with the SCID/DSM-IV section for mood disorders. Clinicians conducting the SCIDs at 6- and 12-months follow-up are blinded to treatment condition. That means that they do not know whether a participant is in the intervention or control group. Secondary outcomes include depressive symptomatology, anxiety and quality of life. An economic evaluation using a societal perspective will be conducted to examine the intervention’s cost-effectiveness.
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
- DRKS00004709
- 2013/02/19
- [---]*
- yes
- Approved
- AZ-2012-35K, Ethik-Kommission des Fachbereichs Psychologie an der Philipps-Universität Marburg
Secondary IDs
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Health Condition or Problem studied
- Depression
- F32 - Depressive episode
Interventions/Observational Groups
- interactive 6-weeks self-help training (GET.ON Mood) with 6 lessons that focus on psychoeducation, behavioural activation, and problem-solving. Additionally, 3 modules (better sleep, less worrying, relaxation) free to choose are offered. After completing each lesson participants receive an individualised feedback written by an online-trainer. Participants are also asked to keep a mood- and activity diary. Participants are not blinded to treatment condition meaning that they know whether they are in the intervention (GET.ON Mood) or control group (psychoeducation-only).
- Psychoeducation-only control without guidance provided by an online-trainer.
Characteristics
- Interventional
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- Randomized controlled trial
- Blinded
- assessor, data analyst
- Active control
- Prevention
- Parallel
- N/A
- N/A
Primary Outcome
The primary outcome is time to onset of MDD within a 12 months follow-up with the SCID/DSM-IV section for mood disorders assessed at 6- and 12-months follow-up.
Secondary Outcome
-depressive symptomatology (CES-D): baseline, post (7 weeks), 6, and 12 months
-quality of life (EuroQol, SF-12): baseline, post, 6, and 12 months
-direct and indirect health care costs (German adaptation of the Trimbos/iMTA questionnaire for costs associated with psychiatric illness (TiC-P)): baseline, 6 and 12 month
- Symptoms of anxiety (HADS, anxiety subscale): baseline, post, 6, and 12 months
-problem-solving (social problem-solving inventory, short version): baseline, post, 6, and 12 months
- behavioural activation (behavioural activation depression scale, BADS): baseline, post, 6, and 12 months
- Worrying (Penn State-Worrying-Questionnaire, PSQW, short version): baseline, post, 6, and 12 months
- Insomnia Severity, Insomnia Severity Index (ISI): baseline, post, 6 and 12 month-follow-up
- Mastery (Pearlin & Schooler Mastery Scale): baseline, post, 6 and 12 months
- Treatment credibility/participants' expectancy (Treatment credibility/patient expectancy questionnaire, CEQ): baseline and post
- participants' satisfaction (participants' satisfaction questionnaire): post
- Attitudes towards psychological help: baseline, post, 6 – and 12 months
-side-effects of psychotherapy (INEP): post and 6 months
Countries of Recruitment
- Germany
Locations of Recruitment
- other
Recruitment
- Actual
- 2013/03/01
- 406
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
-18 years of age
-depressive symptoms (CES-D equal or greater to 16)
- internet access
- valid email address
Exclusion Criteria
-Acute major depressive episode, psychotic symptomatology, bipolar disorder
-Major depressive episode in the past six months
-Receiving treatment for any kind of mental health disease
-Being on a waiting list for any kind of mental health treatment
- Suicidal risk (BDI item 9 > 1)
Addresses
-
start of 1:1-Block address primary-sponsor
- Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
- Mr. David Ebert
- Rotenbleicher Weg 67
- 21335 Lüneburg
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 041316777654
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- ebert at inkubator.leuphana.de
- http://www.leuphana.de/inkubator/gesundheit/geton.html
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
- Ms. M.Phil Claudia Buntrock
- Rotenbleicher Weg 67
- 21335 Lüneburg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 041316777639
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- buntrock at inkubator.leuphana.de
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
- Ms. M.Phil Claudia Buntrock
- Rotenbleicher Weg 67
- 21335 Lüneburg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 041316777639
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- buntrock at inkubator.leuphana.de
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end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Investitions-und Förderungsbank Niedersachsen (NBank)
- Günther-Wagner-Allee 12-16
- 30177 Hannover
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- 0511 300310
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- info at nbank.de
- http://www.nbank.de
end of 1:1-Block address contact materialSupport -
start of 1:1-Block address otherSupport
- European Union
- 1000 Brüssel
- Belgium
end of 1:1-Block address otherSupportstart of 1:1-Block address contact otherSupport- [---]*
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- http://www.europa.eu
end of 1:1-Block address contact otherSupport
Status
- Recruiting complete, follow-up continuing
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