RecruitingNot ApplicableNCT06677515

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

Sponsor

Sykehuset Innlandet HF

Enrollment

102 participants

Start Date

May 8, 2025

Study Type

INTERVENTIONAL

Conditions

Substance Use Disorders Mental Disorder

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

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 Criteria3

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

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Interventions

OTHERVR 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.