NCT06728241 Virtual Reality and Artificial Intelligence in Treatment for Patients With Psychosis
| NCT ID | NCT06728241 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Psychosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-12-06 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-12-06 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Virtual Reality (VR) has gained momentum in the treatment of various mental health conditions. Despite its potential and emphasis on better use of technology in healthcare strategies, VR therapy for severe mental illness remains underdeveloped and understudied. This will be the first randomized controlled trial to combine cognitive behavioral therapy-based VR with state-of-the-art Artificial Intelligence. Reduced quality of life, social withdrawal and inactivity found in psychotic disorders may be largely explained by avoidance due to severe symptoms of anxiety, present in as many as two-thirds of patients with schizophrenia. Alleviating anxiety may thus be key to help improve functional outcomes. The aim of this study is to provide novel information about VR therapy in psychosis employing the newly developed RecoVRy application. Study objectives are to examine short- and long-term effects on real-world functioning, psychiatric symptoms, and quality of life. A total of 150 participants will be recruited from five Norwegian hospitals. Participants will be randomly assigned to either receive the RecoVRy intervention (N=75) alongside treatment as usual or a control intervention (N=75) in which they engage with three distinct VR games. RecoVRy will generate new and important knowledge to improve mental health services in psychosis and hopefully improve existing practise and facilitate personalized treatment. RecoVRy will fill knowledge gaps concerning anxiety in psychosis, as this is often left untreated and consequently create societal benefits by increasing social and functional participation. Finally, knowledge from RecoVRy can easily be generalized to other patient groups and health sectors.
Eligibility Criteria
Inclusion Criteria: * 17 -65 years of age * Receiving psychosis treatment at either clinic in the participating hospital trusts * A clinical diagnosis of schizophrenia spectrum psychosis according to ICD-10 (F20 - F29) or an affective diagnosis with psychotic symptoms (F31.2, F31.5, F32.3, F33.3) * Self-reported difficulties going outside or taking part in everyday activities * Willing and able to provide written informed consent for participation in the study Exclusion Criteria: * Photosensitive epilepsy * Substantial visual, auditory, or balance impairments * Insufficient comprehension of Norwegian * Currently receiving treatment in a forensic setting or Psychiatric Intensive Care Unit * Primary diagnosis of alcohol or substance use disorder or personality disorder; organic syndrome * Clinically significant learning disability
Contact & Investigator
Jan Ivar Røssberg, PhD
PRINCIPAL INVESTIGATOR
Universitetet i Oslo/Oslo universitetssykehus
Frequently Asked Questions
Who can join the NCT06728241 clinical trial?
This trial is open to participants of all sexes, aged 17 Years or older, up to 65 Years, studying Psychosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06728241 currently recruiting?
Yes, NCT06728241 is actively recruiting participants. Contact the research team at j.i.rossberg@medisin.uio.no for enrollment information.
Where is the NCT06728241 trial being conducted?
This trial is being conducted at Oslo, Norway, Nydalen, Norway.
Who is sponsoring the NCT06728241 clinical trial?
NCT06728241 is sponsored by Oslo University Hospital. The principal investigator is Jan Ivar Røssberg, PhD at Universitetet i Oslo/Oslo universitetssykehus. The trial plans to enroll 150 participants.