Trial document




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  DRKS00004708

Trial Description

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Title

Online-training for patients with Major Depresssion on a waiting list for inpatient psychotherapy

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Trial Acronym

Geton-D-WL

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URL of the Trial

http://www.gesundheitstrainingsonline.de/DepressionPraestation.php

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Brief Summary in Lay Language

The newly developed online-based treatment is aimed to reach patients with major depressions who are on a waiting list for inpatient therapy. Major depression is a common and severe disorder. Hopelessness, sadness, and despair are just some feelings the individual has to sustain. Even though the disorder is treatable, people searching for help are still confronted with many barriers. One particular problem are the often long waiting periods before therapies become available. During this time the individual is faced with continuous symptoms and associated difficulty with everyday life. Possibly, the condition even gets worse. However, there are treatments available that might help such individuals while being on a waiting list. Particularly, web-based interventions might help patients overcome the time of waiting for an inpatient treatment by easing depressive symptoms, and preparing the individual optimally for a successful inpatient therapy. Because no face-to-face contact with the therapist is needed, the patient can follow the treatment at home or any other convenient place.

The aim of the study is to examine whether the developed online-treatment is effective in reducing depressive symptoms. Thus, patients might start inpatient therapy with reduced depressive symptoms and remission rates could be increased.

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Brief Summary in Scientific Language

Major Depression (MD) is a prevalent and severe disorder. Several effective treatments for MD are available, but patients often have to wait for a significant period of time before they get access to treatment. This waiting period is associated with prolonged suffering and impairment. Additionally, a lot of patients are discharged from hospital with residual symptoms. Web-based interventions may help to alleviate these problems. Such interventions have been shown to be efficacious in reducing depressive symptoms in numerous studies. They can be offered with limited therapeutic resources and delivered independently from the spatial distance between patient and therapist. The aim of this study is to develop and evaluate a new online-based guided self-help intervention (Get.On-D) for MD patients who are on a waiting list for inpatient therapy.
In a two-arm randomised controlled trial (n=200) we compare the online-based intervention Get.On-D in addition to TAU with TAU alone. The three weeks program contains six modules, including psychoeducation, behavioral activation and problem solving. The participants will be supported by an ecoach who provides written feedback after each module. Inclusion criteria are the diagnosis of MD (assessed with SCID I) and being on a waiting list for inpatient therapy for at least three weeks. Primary outcome is the reduction of depressive symptoms. Further (explorative) questions are whether remission is reached earlier and by more patient during inpatient therapy. Alongside a cost-effectiveness analysis from a societal perspective will be conducted.
If Get.On-D is proven to be effective patients might start inpatient therapy with reduced depressive symptoms and remission rates could be increased.

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Organizational Data

  •   DRKS00004708
  •   2013/02/11
  •   [---]*
  •   yes
  •   Approved
  •   AZ-2012-37kr, Ethik-Kommission des Fachbereichs Psychologie an der Philipps-Universität Marburg
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Secondary IDs

  •   U1111-1139-3608 
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Health Condition or Problem studied

  •   F32.1 -  Moderate depressive episode
  •   F32.2 -  Severe depressive episode without psychotic symptoms
  •   F33.1 -  Recurrent depressive disorder, current episode moderate
  •   F33.2 -  Recurrent depressive disorder, current episode severe without psychotic symptoms
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Interventions/Observational Groups

  •   interactive three weeks self help program (Get.On-D) with 6 sessions, which focus 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. Already during their waiting time patients have the chance with help of this training to get to know and get used to techniques which are relevant for subsequent therapy.
  •   Care as Usual (patients receive standard care as before, which means they're allowed to get every kind of health care offer and/or remain in outpatient therapy)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Single blind
  •   [---]*
  •   No treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Depression severity (observer rated), measured with the Quick Inventory of Depressive Symptomatology (QIDS, Rush, 2003) before the treatment (baseline=pre) and afterwards (3 weeks=post)

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Secondary Outcome

- depressive symptomatology (Hamilton Rating Scale for Depression, HRSD): pre, post
- course of depressive symptoms (Patient-Health-Questionnaire, PHQ-9): pre, post, follow up I (start inpatient therapy), weekly monitoring during inpatient therapy, follow up II (after inpatient therapy)
- worrying (Penn State-Worry-Questionnaire, PSWQ, short version): pre, post, follow up I+II
- activity level (Behavioural Activation Depression Scale, BA-DS, short version): pre, post, follow up I+II
- problem solving (Social Problem Solving Inventory): pre, post, follow up I+II
- life quality (EuroQol): pre, post, follow up I+II
- costs associated with depressive symptoms (German adaptation of the Trimbos/iMTA Questionnaire for Costs associated with Psychiatric Illness (TiC-P)): pre, post

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2013/02/18
  •   200
  •   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

- diagnose of a moderate or severe depression (structured clinical interview, SCID)
- on the waiting list for inpatient psychotherpy in the Schön-Klinik, Bad Arolsen
- access to the internet
- valid email address

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Exclusion Criteria

- acute psychosis (at baseline)

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Addresses

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    • Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
    • Mr.  David Ebert  Lehr 
    • Rotenbleicher Weg 67
    • 21335  Lüneburg
    • Germany
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    • Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
    • Ms.  Jo Annika  Reins 
    • Rotenbleicher Weg 67
    • 21335  Lüneburg
    • Germany
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    • Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
    • Ms.  Jo Annika  Reins 
    • 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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    • European Union
    • 1000  Brüssel
    • Belgium
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Status

  •   Recruiting planned
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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.