VR as a Facilitator for Participation in Society Among Pe... | NCT05653167

Studies
VR as a Facilitator for Participation in Society Among Persons With MHD/SUD

NCT05653167

Sponsor

Sykehuset Innlandet HF

Status

Unknown status

Last Update Posted

Nov 28, 2023Actual

Enrollment

124Actual

Phase

Not provided

Conditions

Substance Use Disorders
Mental Disorder

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2022Actual

Primary Completion Date

Aug 31, 2023Actual

Completion Date

Dec 2024Estimated

First Submitted Date

Oct 28, 2021

First Submission Date that Met QC Criteria

Dec 7, 2022

First Posted Date

Dec 16, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2023

Last Update Posted Date

Nov 28, 2023Actual

Name	Class
Inland Norway University of Applied Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

124Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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].

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lars Lien, MD, Ph.d	Sykehuset Innlandet HF	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Innlandet Hospital Trust		Brumunddal		2381	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40835410	Derived	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.

ID	Term
D019966	Substance-Related Disorders
D001523	Mental Disorders