RecoVRy - A Randomized Controlled Trial Examining the Effect of Artificial Intelligence Powered Virtual Reality Treatment in Psychosis

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 17
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Norway
Oslo University Hospital
ACTIVE_NOT_RECRUITING
Nydalen
Oslo University Hospital
RECRUITING
Oslo
Contact Information
Primary
Jan Ivar Røssberg, Professor
j.i.rossberg@medisin.uio.no
+47 47876866
Backup
June U Lystad, PhD
j.u.lystad@psykologi.uio.no
+47 95037099
Time Frame
Start Date: 2024-12-06
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 150
Treatments
Active_comparator: RecoVRy
Patients randomized to this arm will receive CBT assisted artificial intelligence driven Virtual Reality therapy for a total of ten sessions.
Sham_comparator: VR Games
Patients in the control group will receive ten sessions of different virtual reality games.
Related Therapeutic Areas
Sponsors
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov