Trial document




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  DRKS00011514

Trial Description

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Title

Online Prevention Program for Bereaved Siblings: A Randomised Controlled Trial

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Trial Acronym

TRAUGES

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URL of the Trial

http://www.trauernde-geschwister.org

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Brief Summary in Lay Language

[---]*

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Brief Summary in Scientific Language

A randomised controlled trial to evaluate an internet-based prevention program for adolescents and adults who have lost a sibling. The sample is planned to include 100 bereaved siblings. The 6 weeks treatment is based on principles of cognitive behavioral therapy (exposition, cognitive restructuring). The control group receives the treatment after a 6 weeks waiting time. Measurements include bereavement-specific and psychopathological variables as well as the therapeutic relationship and are recorded at several points of time (pre; post; follow-up after 3, 6 and 12 months).

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Organizational Data

  •   DRKS00011514
  •   2017/01/10
  •   [---]*
  •   yes
  •   Approved
  •   MSB-2017/02, Hamburg - Ethik-Kommission der MSH Medical School Hamburg
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Secondary IDs

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

  •   berreavement reactions
  •   depression
  •   anxiety
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Interventions/Observational Groups

  •   An internet based prevention program: The 6-week online writing-therapy is based on cognitive behavioral principles (exposition, cognitive restructuring, coping with difficult feelings like e.g. guilt). The patients are guided through the therapy by trained psychologists who give them 2 writing-instructions per week and give individual feedback to the written texts.
  •   Control-group starting with the writing-therapy after a waiting time of 6 weeks.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Prevention
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Reduction of bereavement-specific symptoms (ICG, PTCI, IES), Depression (BDI-II) and Anxiety (PHQ-D) after the 6 weeks treatment.

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Secondary Outcome

Family cohesion (FB-K, EXIS), social support (BSSS), guilt (FIS) and working alliance (WAI) after the 6 weeks treatment and follow up (after 3, 6 and 12 months)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/03/13
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   16   Years
  •   65   Years
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Additional Inclusion Criteria

1. Loss through death of a brother or a sister
2. Male and female
3. Adults (age 16-65)
4. Access to Internet
5. Germanspeaking
6. Signed letter of agreement

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Exclusion Criteria

1. Suicidal tendency
2. High level of depression (BDI > 25)
3. Psychotic experiences
4. Increased use of alcohol, drugs or other substances
5. Persons attending a psychotherapeutical treatment
6. Selfinjuring behaviour
7. Borderline personality disorder
8. Bipolar disorder

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Addresses

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    • MSB Medical School Berlin
    • Calandrellistr. 1-9
    • 12247  Berlin
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Bundesverband Verwaiste Eltern und trauernde Geschwister in Deutschland e.V.
    • Germany
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    • MSB Medical School Berlin
    • Ms.  Prof. Dr.  Birgit  Wagner 
    • Calandrellistr. 1-9
    • 12247  Berlin
    • Germany
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    • MSB Medical School Berlin
    • Ms.  Nicole  Rosenberg 
    • Calandrellistr. 1-9
    • 12247  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministeriums für Familie, Frauen, Senioren und Jugend
    • 11018  Berlin
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
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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.