Trial document




This trial has been registered retrospectively.
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  DRKS00013947

Trial Description

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Title

Using virtual reality to reduce cognitive biases in psychosis

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Cognitive distortions are associated with the formation and maintenance of delusions. Studies show that correcting cognitive distortions (e.g. jumping to conclusions bias) may also reduce psychotic symptoms. The aim of this study is to investigate whether the correction of overconfidence in false memories via a virtual reality intervention leads to an improvement of delusional ideation in people with a psychosis.

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Brief Summary in Scientific Language

Cognitive distortions are associated with the formation and maintenance of delusions. Studies show that correcting cognitive distortions (e.g. jumping to conclusions bias) may also reduce psychotic symptoms. The aim of this study is to investigate whether the correction of overconfidence in false memories via a virtual reality intervention leads to an improvement of delusional ideation in people with a psychosis. A randomised, controlled design was used. The participants complete four different virtual scenarios. Afterwards they are asked for previously shown persons and objects. The intervention group receives feedback on errors in the recognition task to correct possible overconfidence in false memories. The control group receives no feedback. The goal is to decrease overconfidence in false memories by providing corrective experiences and consequently reduce delusional ideation.

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Organizational Data

  •   DRKS00013947
  •   2018/06/25
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  •   yes
  •   Approved
  •   SM 112015, Deutsche Gesellschaft für Psychologie
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Secondary IDs

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Health Condition or Problem studied

  •   F20 -  Schizophrenia
  •   Psychosis
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Interventions/Observational Groups

  •   Feedback group (participants receive immediate feedback for errors in a recognition task).
    The participants undergo four different virtual scenarios. Afterwards, they are asked for previously shown persons and objects. The intervention group receives feedback on errors in the recognition task to correct possible overconfidence in false memories.
  •   No feedback group (participants do not receive feedback for errors).
    The participants undergo four different virtual scenarios. Afterwards, they are asked for previously shown persons and objects. The control group receives no feedback on their performance (e.g. errors) in the recognition task.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   II-III
  •   N/A
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Primary Outcome

Reduction of psychotic symptoms, measured with:

Four weeks after baseline:
Positive and Negative Syndrome Scale (PANSS),
Psychotic Symptom Rating Scales (PSYRATS)

Immediatly after the VR (virtual reality) Intervention:
Paranoia Checklist,
Community Assessment of Psychic Experiences

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Secondary Outcome

Feasibility and accaptence of the virtual reality and head-mounted display, measured immediatly after the VR intervention:
Simulation Sickness Questionnaire

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/02/08
  •   90
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- current or past psychotic episode (verified via the MINI)
- informed consent

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Exclusion Criteria

- history of seizures or epilepsy
- other neurologic disorders

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Asklepios Klinik Nord - Wandsbek
    • Prof. Dr.  Matthias  Nagel 
    • Jüthornstr. 71
    • 22043  Hamburg
    • Germany
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    • Asklepios Klinik Nord - Wandsbek
    • Mona  Dietrichkeit 
    • Jüthornstraße 71
    • 22043  Hamburg
    • Germany
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    • Asklepios Klinik Nord - Wandsbek
    • Mona  Dietrichkeit 
    • Jüthornstraße 71
    • 22043  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Asklepios proresearch
    • Lohmühlenstraße 5
    • 20099  Hamburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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