NCT06677515 Improving Social Functioning in People With Substance Use and Mental Health Disorders Using VR
| NCT ID | NCT06677515 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sykehuset Innlandet HF |
| Condition | Substance Use Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2025-05-08 |
| Primary Completion | 2026-06 |
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 102 participants in total. It began in 2025-05-08 with a primary completion date of 2026-06.
⚠ 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
ROPVR, a multi-centre, pragmatic randomized controlled trial (RCT) aims to evaluate a VR-technology which has been developed within an exploratory study and a development study, which facilitates social functioning among persons with a substance use and mental health disorder. Investigators will test a VR-program versus treatment as usual among patients enrolled into a long-term addiction-treatment facility. The RCT aims to evaluate the effectiveness of VR training compared to treatment as usual in improving resilience, quality of life, practical and social functioning and social participation (from baseline to 6 months), and to evaluate the cost-effectiveness of VR training versus treatment as usual.
Eligibility 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
Contact & Investigator
Marja Leonhardt, PhD
PRINCIPAL INVESTIGATOR
Sykehuset Innlandet HF
Frequently Asked Questions
Who can join the NCT06677515 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Substance Use Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06677515 currently recruiting?
Yes, NCT06677515 is actively recruiting participants. Contact the research team at marja.leonhardt@sykehuset-innlandet.no for enrollment information.
Where is the NCT06677515 trial being conducted?
This trial is being conducted at Brumunddal, Norway, Hamar, Norway.
Who is sponsoring the NCT06677515 clinical trial?
NCT06677515 is sponsored by Sykehuset Innlandet HF. The principal investigator is Marja Leonhardt, PhD at Sykehuset Innlandet HF. The trial plans to enroll 102 participants.