Substance Use DisordersROPVRNCT06677515
Improving Social Functioning in People With Substance Use and Mental Health Disorders Using VR
A study testing VR training in people with Substance Use Disorders and Mental Disorder, run by Sykehuset Innlandet HF at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Substance Use Disorders, Mental Disorder
- What is being tested?
- VR training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesNorway
- Study dates
- 8 May 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 2 recruiting
- Recruiting
Innlandet Hospital Trust
Brumunddal, 2381
Marja Leonhardt, Ph.d
- Recruiting
Sykehuset Innlandet HF
Hamar
Anne Bech, PhD, +4741104262, anne.bech@sykehuset-innlandet.no
About this study
Official title: 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
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
- Being tested
- VR training
- Medical subject headings
- Substance-Related Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR trainingOther
Also called Training, using a virtual reality goggles
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrolement into the study until ca. 6 month
Secondary outcomes (4)
Practical and social functioning
Measured by the Practical and Social Functioning Scale (PSF 3) consists of 32 items and 8 domains: personal hygiene, communication, managing economy, housekeeping, contact with social network, personal health care, transportation, and work and activities. Each item is rated on a five-point response scale from 1 (does not apply) to 5 (applies completely). Based on the completed form, scores for the different parts can be calculated as follows:
Total score for the entire scale with 28 items (sum 28 - 140, average score 1.0 - 5.0) Subscales (sum for each subscale 5 - 20, average score 1.0 - 5.0) Dimension activity (16 items, sum 16 - 80, average score 1.0 - 5.0) Dimension participation (12 items, sum 12 - 60, average score 1.0 - 5.0
Measured: From enrolement into the study until ca. 6 month
Social participation
Mini-SCOPE comprises 25 items and measures 5 domains of Satisfaction with Opportunities (SatOpps) in terms of leisure time, community involvement, work, finances and family; 2 domains of Perceived Opportunities (PerOpps) regarding housing and income. It also contains a question on the perceived level of overall social inclusion and a question on the perceived level of quality of life. Mini-SCOPE includes 17 scorable items, while 8 other items are either Yes/No questions or about basic demographics. The SatOpps items were measures on a 7-point scale, ranging from 'delighted' to 'terrible', while the PerOpps items were measures on a 5-point scale. SatOpps and PerOpps are scored by calculating the sum of the items. Overall social inclusion and quality of life are single items and are scored separately. In all scorable items, higher scores indicate lower satisfaction opportunities, perceived opportunities or satisfaction with social inclusion and quality of life.
Measured: From enrolement into the study until ca. 6 month
Resilience
To measure resilience, the Connor-Davidson Resilience Scale, 10 item version (CD-RISC 10) will be used. The CD-RISC-10 consists of 10 statements describing different aspects of resilience. The scale serves mainly as a measure of hardiness, with items corresponding to flexibility (1 and 5), sense of self-efficacy (2, 4 and 9), ability to regulate emotion (10), optimism (3, 6 and 8) and cognitive focus/maintaining attention under stress (7). Each item is scored on a five-point scale ranging from 0 to 4, with 0 representing that the resilience statement is not at all true and a score of 4 indicating that the statement is true nearly all the time. The total score is obtained by adding up all 10 items. The total can therefore range from 0 to 40. Higher scores suggest greater resilience and lower scores suggest less resilience, or more difficulty in bouncing back from adversity.
Measured: From enrolement into the study until ca. 6 month
Cost-effectiveness
Health state descriptions of the study participants will be measured by EQ-5D-5L at baseline (T0), T1, T2 and T3. The EQ-5D-5L is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys. It comprises comprises five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The five levels in each dimension are worded as (1) 'not /no problems', (2) 'slight problems', (3) 'moderate problems', (4) 'severe problems', and (5) 'unable to' (mobility, self-care, usual activities), 'extreme' (pain/depression), or 'extremely' (anxiety/depression). Healthcare resource use, will be assessed using The Treatment Inventory of Costs in Patients with Psychiatric Disorders (TIC-P).
Measured: From enrolement into the study until ca. 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start8 May 2025
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marja Leonhardt, PhD, Principal investigator, Sykehuset Innlandet HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677515
- Sponsor's protocol ID
- 326773VR_WP3
- Acronym
- ROPVR
- Status last verified
- Jan 2026
- First submitted
- 4 Nov 2024
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: As we are collecting sensitive data, we are by rules and regulations not allowed to share any data. However, we might consider sharing pseudonymized data gradually.
Publications
Bech AB, Wechsler TF, Muhlberger A, Lien L, Leonhardt M. Improving social functioning in people with substance use and mental health disorders using virtual reality (ROPVR): study protocol for a multi-center, pragmatic randomized controlled trial. Trials. 2026 Apr 10;27(1):367. doi: 10.1186/s13063-026-09676-6.
PubMed 41957842
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06677515
- Acronym / sponsor ID
- ROPVR / 326773VR_WP3
- Conditions
- Substance Use Disorders, Mental Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Study start
- 8 May 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality (VR) training | Experimental | Other: VR trainingParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR trainingAlso: Training, using a virtual reality gogglesThe 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. | Other | Virtual reality (VR) training |
Primary outcome
Health and disability
Time frame: From enrolement into the study until ca. 6 month
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.
4 secondary outcomes
Practical and social functioning
Time frame: From enrolement into the study until ca. 6 month
Social participation
Time frame: From enrolement into the study until ca. 6 month
Resilience
Time frame: From enrolement into the study until ca. 6 month
Cost-effectiveness
Time frame: From enrolement into the study until ca. 12 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Derived from this study: PubMed 41957842Bech AB, Wechsler TF, Muhlberger A, Lien L, Leonhardt M. Improving social functioning in people with substance use and mental health disorders using virtual reality (ROPVR): study protocol for a multi-center, pragmatic randomized controlled trial. Trials. 2026 Apr 10;27(1):367. doi: 10.1186/s13063-026-09676-6.
- Project website - in Norwegian onlyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. As we are collecting sensitive data, we are by rules and regulations not allowed to share any data. However, we might consider sharing pseudonymized data gradually.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marja Leonhardt, PhD principal investigator
Sykehuset Innlandet HF
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR training in people with Substance Use Disorders and Mental Disorder, run by Sykehuset Innlandet HF at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marja Leonhardt, PhD (+4747150465, marja.leonhardt@sykehuset-innlandet.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health and disability (time frame: From enrolement into the study until ca. 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06677515, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.