Status:
COMPLETED
CHALLENGE. A Randomised Clinical Trial Examining Virtual Reality Therapy
Lead Sponsor:
Mental Health Services in the Capital Region, Denmark
Collaborating Sponsors:
Region of Southern Denmark
Mental Health Services in the North Denmark Region
Conditions:
Auditory Hallucinations
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study is a randomised, assessor-blinded parallel-groups superiority clinical trial, allocating a total of 266 patients to either the experimental intervention or standard intervention. The partici...
Detailed Description
Auditory hallucinations are among the most frequent symptoms in psychotic disorders. While a large group of patients with first episode psychosis achieve remission of psychotic symptoms during first y...
Eligibility Criteria
Inclusion
- Age 18 - years
- Ability to give informed consent
- A schizophrenia spectrum disorder (ICD-10 code: F20 -F29)
- Auditory hallucinations for at least three months, corresponding to a SAPS score on auditory hallucinations of ≥3.
- No changes in antipsychotic medication within the past four weeks and
- Not responding to current antipsychotic compound or
- Not responding to at least two antipsychotic compounds. Table2
Exclusion
- Rejecting informed consent
- Unable to identify a single dominant voice to work on
- A diagnosis of organic brain disease
- Substance to a level that hinders engagement in therapy.
- Auditory hallucinations in a language not spoken by the therapists
- A command of spoken Danish or English inadequate for engaging in therapy
- Inability to tolerate the assessment process
- Strongly impaired vision
Key Trial Info
Start Date :
November 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2024
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT04661163
Start Date
November 16 2020
End Date
April 2 2024
Last Update
November 25 2024
Active Locations (1)
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1
Copenhagen Research Center for Mental Health - CORE
Copenhagen, Hellerup, Denmark, 2900