Trial document




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  DRKS00013742

Trial Description

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Title

Evaluation of an Internet intervention for the treatment of OCD

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Trial Acronym

Zwanglos

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of this online-study is to examine feasibilty and efficacy of a newly developed Internet invervention for the treatment of OCD. This unguided self-help intervention comprises evidence-based cognitive-bahavioural methods and can be used anonymously. We test efficacy within a single-blinded, randomized-controlled design (intervention vs. care as usual) with an intervention period of 8 weeks. Symtom severity will be assessed in online-selfratings pre and post. Primary outcome = OCD symptom severity. Secondary outcomes further examine quality of life, comorbid depression etc. We include individuals with an age between 18 and 65 who experience OCD symptoms. We exclude individuals with psychotic or suicidal symptoms. We recruit via various sources, e.g. facebook, online-forums and OCD specific networks.

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Brief Summary in Scientific Language

Evaluation of feasibility and efficacy of an Internet intervention for OCD

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Organizational Data

  •   DRKS00013742
  •   2018/01/15
  •   [---]*
  •   yes
  •   Approved
  •   2017_105, Ethikkommission der Universität Hamburg
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Secondary IDs

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

  •   F42 -  Obsessive-compulsive disorder
  •   F32 -  Depressive episode
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Interventions/Observational Groups

  •   - Anonymous online assessment (pre)

    - 8 weeks selfhelp Internet intervention + Care as usual

    - Anonymous online assessment (post)
  •   - Anonymous online assessment (pre)

    - Waitlist + Care as usual

    - Anonymous online assessment (post)
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Characteristics

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

- Pre and Post assessment with a German version of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS); operationalization of OCD symptom severity

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Secondary Outcome

- pre - Attitudes towards online interventions questionnaire (APOI)

- pre & post - Obsessive Compulsive Inventory-Revised (OCI-R)
Obsessive Beliefs Questionnaire (OBQ-44), Impulsives-Verhalten-8 (I8),
Patient-Health-Questionnaire-9 (PHQ-9)
WHO Quality of Life-BREF (WHOQoL-BREF)
Rosenberg Self-Esteem Scale (RSE)
Unsicherheits-Fragebogen (U-FB)

- post - Evaluation of adverse events, subjective appraisal, Client Satisfaction Questionnaire (CSQ-8)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2018/01/15
  •   128
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Y-BOCS > 7

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Exclusion Criteria

manic symptoms, psychotic symptoms, acute suicidality

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Psychiatrie und Psychotherapie
    • Ms.  Dr.  Johanna  Schröder 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf
    • Ms.  Dr.  Johanna  Schröder 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf
    • Ms.  Dr.  Johanna  Schröder 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Psychiatrie und Psychotherapie
    • Mr.  Prof.Dr.  Steffen  Moritz 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    •   (0)40 7410 56565
    •   [---]*
    •   moritz at uke.de
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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.