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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05653167
Other study ID # 326773VR_WP1
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date December 2024

Study information

Verified date November 2023
Source Sykehuset Innlandet HF
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 124
Est. completion date December 2024
Est. primary completion date August 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
Norway Innlandet Hospital Trust Brumunddal

Sponsors (2)

Lead Sponsor Collaborator
Sykehuset Innlandet HF Inland Norway University of Applied Sciences

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Practical and social functioning measured by the Practical and Social Functioning Scale (PSF) 2 hours
Primary Social inclusion Measured by the Social and Community Opportunities Profile (SCOPE) 2 hours
Primary Barriers for participation in society This will be assessed within in-depth interviews duration of the in-depth interview
Primary Facilitators for participation in society This will be assessed within in-depth interviews duration of the in-depth interview
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