Substance Use DisordersSOPATMEDVR1NCT05653167
VR as a Facilitator for Participation in Society Among Persons With MHD/SUD
An observational study of Substance Use Disorders and Mental Disorder, run by Sykehuset Innlandet HF at 1 site in Norway.
Trial summary
This study is the first part of a larger project called "Virtual Reality (VR) as a facilitator for participation in society among persons with mental health/substance use disorders" in which aims to explore,develop and evaluate a VR-based paradigm that facilitates social participation and promotes social recovery of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders, Mental Disorder
- How many people
- 124 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2022to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population comprises persons with a self reported addiction and mental health disorder who receive services in the municipality. Further, we interview staff (nurses, mental health workers, psycologists, social workers) from the municipal mental health and addiction services.
Who may be able to join
- above 18 years of age
- receiving services in the municipality due to mental health and or addiction problems.
Who cannot join
- -visual and hearing impairment, neurological disorders, and mental retardation [score ≤70 on the Test of Intelligence].
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Complex Socio-emotional Learning in VR-based Simulation Training Among Persons With Mental Health and/or Substance Use Disorders"
This study is the first part of a larger project called "Virtual Reality (VR) as a facilitator for participation in society among persons with mental health/substance use disorders" in which aims to explore,develop and evaluate a VR-based paradigm that facilitates social participation and promotes social recovery of individuals with mental health and/or substance use disorders (MHD/SUD). The overall project comprises three work packages: an exploration study, a development study, and an evaluation study. This study will make up work package 1. The primary aim of this study (WP1) is to explore facilitators and barriers for participation in society among person with MHD/SUD, and to provide an understanding of mechanisms of social participation and social cohesion among persons with MHD/ SUD that may be affected by VR-based interventions. The investigators will derive a socio-emotional learning domain to facilitate key interpersonal and social processes among persons with MHD/SUD in VR-based interventions. To achieve the purpose of this study, the invistigators conduct 10 indepth interviews with service-user with MHD/SUD, 2 focus group interviews with 14 service-providers and an interview-survey with 100 service users. This gives the investigators the possibility to explore facilitators and barriers for social participation as experienced as by individuals with MHD/SUD and identify key interpersonal and social processes suitable to be addressed by tailored VR based interventions.
- Conditions
- Substance Use Disorders, Mental Disorder
- Medical subject headings
- Substance-Related Disorders, Mental Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Practical and social functioning
measured by the Practical and Social Functioning Scale (PSF)
Measured: 2 hours
Social inclusion
Measured by the Social and Community Opportunities Profile (SCOPE)
Measured: 2 hours
Barriers for participation in society
This will be assessed within in-depth interviews
Measured: duration of the in-depth interview
Facilitators for participation in society
This will be assessed within in-depth interviews
Measured: duration of the in-depth interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start1 Mar 2022
- Primary completion31 Aug 2023
- Study completionDec 2024 (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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Collaborators
- Inland Norway University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Lars Lien, MD, Ph.d, Principal investigator, Sykehuset Innlandet HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653167
- Sponsor's protocol ID
- 326773VR_WP1
- Acronym
- SOPATMEDVR1
- Status last verified
- Nov 2023
- First submitted
- 28 Oct 2021
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aasen J, Nilsson F, Sorensen T, Leonhardt M. Promoting Sustained Real-Life Benefits of Virtual Reality-Based Interventions in People With Mental Health and Substance Use Disorders: Qualitative Study. JMIR Form Res. 2025 Aug 20;9:e57643. doi: 10.2196/57643.
PubMed 40835410
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Socio-emotional Learning in VR-based Simulation Training Among Persons With Mental Health and/or Substance Use Disorders"
- ClinicalTrials.gov ID
- NCT05653167
- Acronym / sponsor ID
- SOPATMEDVR1 / 326773VR_WP1
- Conditions
- Substance Use Disorders, Mental Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Collaborators
- Inland Norway University of Applied Sciences
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 Dec 2022 (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.
This study is the first part of a larger project called "Virtual Reality (VR) as a facilitator for participation in society among persons with mental health/substance use disorders" in which aims to explore,develop and evaluate a VR-based paradigm that facilitates social participation and promotes social recovery of individuals with mental health and/or substance use disorders (MHD/SUD). The overall project comprises three work packages: an exploration study, a development study, and an evaluation study. This study will make up work package 1. The primary aim of this study (WP1) is to explore facilitators and barriers for participation in society among person with MHD/SUD, and to provide an understanding of mechanisms of social participation and social cohesion among persons with MHD/ SUD that may be affected by VR-based interventions. The investigators will derive a socio-emotional learning domain to facilitate key interpersonal and social processes among persons with MHD/SUD in VR-based interventions. To achieve the purpose of this study, the invistigators conduct 10 indepth interviews with service-user with MHD/SUD, 2 focus group interviews with 14 service-providers and an interview-survey with 100 service users. This gives the investigators the possibility to explore facilitators and barriers for social participation as experienced as by individuals with MHD/SUD and identify key interpersonal and social processes suitable to be addressed by tailored VR based interventions.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises persons with a self reported addiction and mental health disorder who receive services in the municipality. Further, we interview staff (nurses, mental health workers, psycologists, social workers) from the municipal mental health and addiction services.
Key inclusion criteria (2 listed)
- above 18 years of age
- receiving services in the municipality due to mental health and or addiction problems.
Key exclusion criteria (1 listed)
- -visual and hearing impairment, neurological disorders, and mental retardation [score ≤70 on the Test of Intelligence].
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Practical and social functioning
Time frame: 2 hours
measured by the Practical and Social Functioning Scale (PSF)
Social inclusion
Time frame: 2 hours
Measured by the Social and Community Opportunities Profile (SCOPE)
Barriers for participation in society
Time frame: duration of the in-depth interview
This will be assessed within in-depth interviews
Facilitators for participation in society
Time frame: duration of the in-depth interview
This will be assessed within in-depth interviews
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 40835410Aasen J, Nilsson F, Sorensen T, Leonhardt M. Promoting Sustained Real-Life Benefits of Virtual Reality-Based Interventions in People With Mental Health and Substance Use Disorders: Qualitative Study. JMIR Form Res. 2025 Aug 20;9:e57643. doi: 10.2196/57643.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Lars Lien, MD, Ph.d principal investigator
Sykehuset Innlandet HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use Disorders and Mental Disorder, run by Sykehuset Innlandet HF at 1 site 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Practical and social functioning (time frame: 2 hours). The study lists 4 primary outcomes in all. 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 NCT05653167, 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 28 Nov 2023.