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RECRUITINGINTERVENTIONAL

Improving Social Functioning in People With Substance Use and Mental Health Disorders Using VR

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form - willing and able to attend VR training two times a week for 5 weeks Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

OTHER

VR training

The different VR scenarios comprise the following learning goals: 1) Social cognition. Interpreting social situations, understanding others; 2) Social communication. Express oneself, being understood by others; 3) Social competence. Interacting with others The investigators will use an MSI Raider GE78HX with a GeForce RTX4080 12GB GPU, running Windows 11, Unreal Engine 5.4, and the Meta Quest Link app, with a Meta Quest Pro as a PCVR headset connected via a Meta Quest Link cable. The setup works 100% locally, and no Wi-Fi or internet connection is used on the head-mounted-display or PC. The VR program itself does not store any data and will discard all that has happened inside the program, when restarted.

Locations (2)

Innlandet Hospital Trust
Brumunddal, Norway
Sykehuset Innlandet HF
Hamar, Norway