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

NCT06677515 | Recruiting

• 1 other identifier: 326773VR_WP3
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Health and disability

  The primary outcome measure is disability measured with the 36-item WHO Disability Assessment Schedule (WHODAS 2.0) total score at 6 months post-intervention. WHODAS 2.0 measures health and disability in adults and captures the level of functioning in 6 domains: cognition, mobility, self-care, getting along, life activities and participation. The scores assigned to each of the items - "none" (1), "mild" (2) "moderate" (3), "severe" (4) and "extreme" (5) - are summed. Scores from each of the items are simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. Higher sum score indicates more problems. WHODAS is based on the conceptual framework of the International Classification of Functioning. WHODAS is trans diagnostic, culturally sensitive and covers all diseases, including physical, mental and substance use disorders. It is is suitable for measuring the clinical effectiveness of interventions.

  From enrolement into the study until ca. 6 month

Secondary Outcomes (4)

• Practical and social functioning

  From enrolement into the study until ca. 6 month

• Social participation

  From enrolement into the study until ca. 6 month

• Resilience

  From enrolement into the study until ca. 6 month

• Cost-effectiveness

  From enrolement into the study until ca. 12 month

Study Arms (2)

Virtual reality (VR) training

EXPERIMENTAL

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.

Other: VR training

Treatment as usual

NO INTERVENTION

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.

Interventions

VR training 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.

Also known as: Training, using a virtual reality goggles

Virtual reality (VR) training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sykehuset Innlandet HF: lead

Study Sites (2)

Innlandet Hospital Trust

Brumunddal, 2381, Norway

RECRUITING

Sykehuset Innlandet HF

Hamar, Norway

RECRUITING

Related Links

• Project website - in Norwegian only

MeSH Terms

Conditions

Substance-Related Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Marja Leonhardt, PhD

  Sykehuset Innlandet HF

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marja Leonhardt, PhD

CONTACT

+4747150465; marja.leonhardt@sykehuset-innlandet.no

Lars Lien, MD, PhD

CONTACT

+4797040683; lars.lien@sykehuset-innlandet.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: May 8, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

NO (2)