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

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

      • Brumunddal, Norway, 2381
        • Innlandet Hospital Trust

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
measured by the Practical and Social Functioning Scale (PSF)
2 hours
Social inclusion
Time Frame: 2 hours
Measured by the Social and Community Opportunities Profile (SCOPE)
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.

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

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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