CHALLENGE. A Randomised Clinical Trial Examining Virtual Reality Therapy
Denmark270 participantsStarted 2020-11-16
Plain-language 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 participants will be randomised to either 12-weeks of virtual reality therapy or supportive counselling. All participants will be assessed at 12- and 24 weeks post baseline. A stratified block-randomisation with concealed randomisation sequence will be conducted. Independent assessors blinded to the treatment will evaluate outcome. Analysis of outcome will be carried out with the intention to treat principles.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Level of auditory hallucinations
Timeframe: 12 weeks from inclusion
Trial details
NCT IDNCT04661163
SponsorMental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital