VR program to improve social functioning for people with substance use and mental health disorders
Improving Social Functioning in People With Substance Use and Mental Health Disorders Using Virtual Reality (ROPVR): Study Protocol for a Multi-centre, Pragmatic Randomized Controlled Trial
This trial will try a virtual reality (VR) training program to see if it helps adults in long-term addiction treatment who also have mental health problems improve social and practical functioning.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sykehuset Innlandet HF Academic / other |
| Locations | 2 sites (Brumunddal and 1 other locations) |
| Trial ID | NCT06677515 on ClinicalTrials.gov |
What this trial studies
This is a multi-centre, pragmatic randomized controlled trial comparing a VR-training program with treatment as usual among adults receiving in-patient addiction treatment in South-East Norway. Participants will be randomized to receive twice-weekly VR training sessions for five weeks or continue usual care, with outcomes measured from baseline to six months. Primary outcomes include resilience, quality of life, practical and social functioning, and social participation, and the trial will also analyze cost-effectiveness of the VR program. The VR intervention was developed in prior exploratory and development work and is now being tested in this larger effectiveness trial.
Who should consider this trial
Good fit: Adults (18+) receiving in-patient substance use disorder treatment in specialized addiction units in South-East Norway who can read Norwegian, give informed consent, and are willing and able to attend VR sessions twice weekly for five weeks are eligible.
Not a fit: People with significant visual, auditory, or balance impairments, epilepsy or other conditions that make VR unsafe, current acute psychosis or active suicidal plans, or severe simulation sickness are unlikely to qualify or benefit from the VR training.
Why it matters
Potential benefit: If successful, the VR training could improve resilience, quality of life, daily social skills, and community participation for people in long-term addiction treatment and may be a cost-effective addition to care.
How similar studies have performed: The VR program was developed after prior exploratory and development studies and VR interventions for mental health and substance use have shown promise in smaller trials, but large pragmatic RCT evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adults aged 18 years or older receiving in-patient SUD treatment in specialized addiction treatment units in South-East Norway. This may include persons serving prison sentences during in-patient treatment according to the Execution of Sentences Act in Norway * having the capability to read, understand and sign the Norwegian informed consent form * willing and able to attend VR training two times a week for 5 weeks Exclusion Criteria: * significant visual, auditory, or balance impairment or other diseases affecting safety during VR sessions (e.g., epilepsy) * current clinically significant severe mental health disorder (e.g., acute episode of psychosis or current active suicidal plans). Persons with psychotic disorders or other severe mental illness are not excluded if their condition is stable. * severe travel sickness as a proxy for simulation sickness
Where this trial is running
Brumunddal and 1 other locations
- Innlandet Hospital Trust — Brumunddal, Norway (Recruiting)
- Sykehuset Innlandet HF — Hamar, Norway (Recruiting)
Study contacts
- Principal investigator: Marja Leonhardt, PhD — Sykehuset Innlandet HF
- Study coordinator: Marja Leonhardt, PhD
- Email: marja.leonhardt@sykehuset-innlandet.no
- Phone: +4747150465
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.