- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05653167
VR as a Facilitator for Participation in Society Among Persons With MHD/SUD (SOPATMEDVR1)
November 22, 2023 updated by: Sykehuset Innlandet HF
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.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Observational
Enrollment (Actual)
124
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Brumunddal, Norway, 2381
- Innlandet Hospital Trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- above 18 years of age
- receiving services in the municipality due to mental health and or addiction problems.
Exclusion Criteria:
-visual and hearing impairment, neurological disorders, and mental retardation [score ≤70 on the Test of Intelligence].
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Practical and social functioning
Time Frame: 2 hours
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measured by the Practical and Social Functioning Scale (PSF)
|
2 hours
|
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Social inclusion
Time Frame: 2 hours
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Measured by the Social and Community Opportunities Profile (SCOPE)
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2 hours
|
|
Barriers for participation in society
Time Frame: duration of the in-depth interview
|
This will be assessed within in-depth interviews
|
duration of the in-depth interview
|
|
Facilitators for participation in society
Time Frame: duration of the in-depth interview
|
This will be assessed within in-depth interviews
|
duration of the in-depth interview
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lars Lien, MD, Ph.d, Sykehuset Innlandet HF
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2022
Primary Completion (Actual)
August 31, 2023
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
October 28, 2021
First Submitted That Met QC Criteria
December 7, 2022
First Posted (Actual)
December 16, 2022
Study Record Updates
Last Update Posted (Actual)
November 28, 2023
Last Update Submitted That Met QC Criteria
November 22, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 326773VR_WP1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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