Trial document





This trial has been registered retrospectively.
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  DRKS00004612

Trial Description

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Title

Internet-based treatment for obsessive-compulsive disorder – acceptance and effectiveness

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Trial Acronym

[---]*

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URL of the Trial

http://www.zwaenge.uniklinik-freiburg.de

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Brief Summary in Lay Language

Obsessive-Compulsive Disorder (OCD) is a severe mental disorder with a high prevalence. OCD is characterized by intrusive thoughts, images or impulses (obsessions), usually followed by ritualized repetitive behavior (compulsions; e.g. hand-washing or checking) that aim at neutralising the obsessive content. Cognitive-behavioral therapy with stimulus exposure and response prevention is the first line treatment for OCD. Even though there is substantial evidence for its effectiveness, many patients do not receive this treatment. Therefore, options to improve the insufficient treatment situation are needed. There are positive findings for the use of Internet-based writing psychotherapy with therapeutic interaction for various other mental disorders. Until now, this approach has not been investigated for OCD. The present research project tests whether such an Internet-based psychotherapy for OCD is accepted by the patients and results in a symptom reduction. Participants receive 14 individualized instructions or exercises for the respective sessions, as well as feedback and assistance from their study-therapists. Communication between participants and therapists occurs exclusively via the Internet.

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Brief Summary in Scientific Language

The study examines whether an Internet-based cognitive-behavioral psychotherapy for adults with OCD is 1.) accepted by the patients in terms of compliance and 2.) effective in reducing the symptoms. Here, particular emphasis is placed on the implementation of exposure with response prevention (ERP). In a randomized-controlled trial the intervention will be compared with a waiting-list control group. Patients will be assessed with established psychopathometric instruments at different time points (baseline, start and end of treatment, follow-up after 8 weeks and 6 months). The treatment focuses on the training and the utilization of ERP. This particular part is embedded in the exploration of symptoms, psychoeducation and processing of functionalities and strategies for relapse prevention. For 8 weeks, participants spend twice a week 45 up to a maximum of 90 minutes with writing assignments or exercises. Therapists initiate this process with half-standardized instructions that are individualized depending on the individual situation of the participant and comprise feedback.

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Organizational Data

  •   DRKS00004612
  •   2012/12/21
  •   [---]*
  •   yes
  •   Approved
  •   21/11, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   F42 -  Obsessive-compulsive disorder
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Interventions/Observational Groups

  •   Experimental intervention: Internet-based cognitive-behavioral psychotherapy for adults with OCD
  •   Control intervention: waiting-list control condition
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   No treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Symptom improvement as measured by the scores of the 'Yale-Brown Obsessive Compulsive Scale' and the 'Obsessive Compulsive Intentory-Revised' (group comparison: pre-post, as well as stability of results at follow-up). Percentage of drop-out at the end of treatment as a measure for the patients’ acceptance and compliance.

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Secondary Outcome

Therapeutical alliance from the patients' view (measured with the Working Alliance Inventory). Therapists’ time effort for conducting the treatment program. Reduction of general psychopathology (Patient Global Impression, BDI-II, Brief Symptom Inventory).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/05/20
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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


Current obsessive-compulsive disorder according to DSM-IV-criteria (Self-rating scale Y-BOCS-SR and OCI-R as well as phone interview); informed consent to participate in the study; fluent in spoken and written German; access to Internet; agreement from their outpatient psychiatrist for crisis intervention

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Exclusion Criteria

Another primary diagnosis of current mental illness besides OCD; severe major depression (according to DSM-IV-criteria); clinically relevant craniocerebral injuries or neurological diseases; current or past legal and illegal drug abuse or dependence (alcohol, drugs, medication); use of benzodiazepine; change of psychotropic medication during the last six month; current acute suicidal tendency; current or past psychotic episode; diagnosis of a borderline personality disorder; current psychotherapeutic treatment; in- or outpatient disorder-specific treatment with exposure and response
prevention in the last 5 years

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Addresses

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    • Universitätsklinikum Freiburg, Abteilung für Psychiatrie und Psychotherapie
    • Mr.  Prof. Dr.   Mathias  Berger 
    • Hauptstraße 5
    • 79104  Freiburg
    • Germany
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    • Schön Klinik Roseneck
    • Mr.  Prof. Dr.  Ulrich  Voderholzer 
    • Am Roseneck 6
    • 83209  Prien am Chiemsee
    • Germany
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    • Freie Universität Berlin Klinische Psychologie und Psychotherapie
    • Ms.  Prof. Dr.  Christine  Knaevelsrud 
    • Habelschwerdter Allee 45
    • 14195  Berlin
    • Germany
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    • Universitätsklinikum Freiburg, Abteilung für Psychiatrie und Psychotherapie
    • Ms.  Dr. phil.  Anne Katrin  Külz 
    • Hauptstraße 5
    • 79104  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Abteilung für Psychiatrie und Psychotherapie
    • Mr.  Nirmal  Herbst 
    • Hauptstraße 5
    • 79104  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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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.