Trial document




drksid header

  DRKS00004709

Trial Description

start of 1:1-Block title

Title

Internet-based prevention of Major Depression

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

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

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004709
  •   2013/02/19
  •   [---]*
  •   yes
  •   Approved
  •   AZ-2012-35K, Ethik-Kommission des Fachbereichs Psychologie an der Philipps-Universität Marburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Depression
  •   F32 -  Depressive episode
end of 1:N-Block indications
start of 1:N-Block interventions

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.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

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.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2013/03/01
  •   406
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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)

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

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-sponsor
    start of 1:1-Block address contact primary-sponsor
    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-contact
    start of 1:1-Block address contact scientific-contact
    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-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

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 materialSupport
    start of 1:1-Block address contact materialSupport
    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 otherSupport
    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2015/03/31
end of 1:1-Block state
* This entry means the parameter is not applicable or has not been set.