Virtual Reality and Artificial Intelligence in Treatment for Patients With Psychosis

NCT06728241 | Recruiting

• 1 other identifier: 763156
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Psychosis

Keywords

Virtual Reality; Artificial Intelligence; Schizophrenia; Psychosis; Anxiety

Outcome Measures

Primary Outcomes (1)

• Oxford Cognitions and Defences Questionnaire (O-CDQ)

  The O-CDQ consists of three subscales: threat cognitions (14 items), anxious avoidance (11 items), and within-situation safety behaviours (8 items). And one total score. The range of scores goes from 0-102. Higher scores mean worse outcome

  From enrollment to the end of treatment at ten weeks.

Secondary Outcomes (29)

• Oxford Cognitions and Defences Questionnaire

  From enrollment to follow-up at 26 weeks

• The Oxford Agoraphobic Avoidance Scale (O-AS)

  From enrollment to the end of treatment at ten weeks.

• The Oxford Agoraphobic Avoidance Scale (O-AS)

  From enrollment to follow-up at 26 weeks

• Positive and Negative Syndrome Scale-6

  From enrollment to the end of treatment at ten weeks.

• Positive and Negative Syndrome Scale-6

  From enrollment to follow-up at 26 weeks

Study Arms (2)

RecoVRy

ACTIVE COMPARATOR

Patients randomized to this arm will receive CBT assisted artificial intelligence driven Virtual Reality therapy for a total of ten sessions.

Behavioral: RecoVRy

VR Games

SHAM COMPARATOR

Patients in the control group will receive ten sessions of different virtual reality games.

Behavioral: VR Games

Interventions

RecoVRy BEHAVIORAL

A mental health professional (VR therapist) will be together with the patient when VR treatment is provided. The VR therapist will help put on the VR headset, start the program and encourage the patient to apply the learning from RecoVRy to real-world challenges by setting up homework tasks to be carried out between VR sessions. The application will run through Meta Quest 2/3®. RecoVRy is designed as a repeated behavioural procedure in which the main focus is for participants to learn that they are safer than assumed. Participants can proceed at their own pace, allowing for more or less than 8 (+/- 2) sessions of VR treatment. Scenarios and levels may be repeated if necessary

RecoVRy

VR Games BEHAVIORAL

Patients randomized to this condition will receive a total of ten sessions of VR games.

VR Games

Eligibility Criteria

• Age: 17 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (2)

Oslo University Hospital

Oslo, Norway, Norway

RECRUITING

Oslo University Hospital

Nydalen, Postboks 4959, Norway

ACTIVE NOT RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Jan Ivar Røssberg, PhD

  Universitetet i Oslo/Oslo universitetssykehus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Ivar Røssberg, Professor

CONTACT

+47 47876866; j.i.rossberg@medisin.uio.no

June U Lystad, PhD

CONTACT

+47 95037099; j.u.lystad@psykologi.uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 11, 2024
• Study Start: December 6, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: March 25, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)