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

NCT ID: NCT06677515

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-08
• Study Completion Date: 2026-12-31

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.

Conditions

Substance Use Disorders; Mental Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual reality (VR) training

Participants randomized to the intervention arm will attend VR sessions twice a week in 5 weeks, or 10 sessions in total. They will be placed into different virtual environments with increasing complexity, where they will be confronted with normal everyday situations in city environments.

In the first session, participants will receive instructions on using the head mounted display and navigating the scenarios. In three scenarios, participants are only observers, while in the remaining they can choose between several response options. These responses will be displayed on the screen, and participants can select their preferred response by pointing their finger to the chosen response alternative. The response alternatives are also provided verbally.

Group Type: EXPERIMENTAL

VR training

Intervention Type: OTHER

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.

Treatment as usual

Treatment of substance use disorders (SUD) is delivered by personnel with medical, psychological, and social expertise, meeting specialist-level healthcare standards. SUD treatment clinics offer patient-centred, interdisciplinary, holistic treatment focusing on physical, mental and social problems. Treatment often consists of both individual and group therapies and include activities (e.g., physical exercise, social activities) in the clinic as well as in external settings. Since treatment approaches and facilities may vary across clinics, patients' preferences or choice of clinic are emphasized. According to national guidelines, persons with SUD and co-occurring severe mental illness (i.e., schizophrenia or severe bipolar disorder) can receive treatment in SUD treatment clinics as long as their mental condition is stable. Otherwise, persons with SUD and severe mental illness receive treatment for both conditions within mental health services.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Training, using a virtual reality goggles

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sykehuset Innlandet HF

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marja Leonhardt, PhD

Role: PRINCIPAL_INVESTIGATOR

Sykehuset Innlandet HF

Locations

Innlandet Hospital Trust

Brumunddal, , Norway

Site Status: RECRUITING

Sykehuset Innlandet HF

Hamar, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Marja Leonhardt, PhD

Role: CONTACT

marja.leonhardt@sykehuset-innlandet.no

+4747150465

Lars Lien, MD, PhD

Role: CONTACT

lars.lien@sykehuset-innlandet.no

+4797040683

Facility Contacts

Marja Leonhardt, Ph.d

Role: primary

Anne Bech, PhD

Role: primary

anne.bech@sykehuset-innlandet.no

+4741104262

Related Links

https://www.sykehuset-innlandet.no/fag-og-forskning/forskning/ropforsk/forskningsprosjekter/rop-vr/

Project website - in Norwegian only

Other Identifiers

326773VR_WP3

Identifier Type: -

Identifier Source: org_study_id