NCT04661163Completed
CHALLENGE. A Randomised Clinical Trial Examining Virtual Reality Therapy
The CHALLENGE-trial: the Effects of a Virtual Reality-assisted Exposure Therapy for Persistent Auditory Hallucinations Versus Supportive Counselling in People With Psychosis
Source: ClinicalTrials.gov · Last updated 25 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 270 (actual)
- First submitted
- 3 Dec 2020
- Start date
- 16 Nov 2020
- Primary completion date
- 27 Feb 2024
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Diseases
- Schizophrenia
- NCT number
- NCT04661163
What you commit to
- Study type: Interventional
- Participants enrolled: 270
- From 16 Nov 2020 to the primary completion date, 27 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Substance to a level that hinders engagement in therapy.
- A command of spoken Danish or English inadequate for engaging in therapy
Other illness
- A diagnosis of organic brain disease
Other
- Rejecting informed consent
- Unable to identify a single dominant voice to work on
- Auditory hallucinations in a language not spoken by the therapists
- Inability to tolerate the assessment process
- Strongly impaired vision
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Copenhagen Research Center for Mental Health (CORE) Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.