NCT05653167

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
10 months until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

1.5 years

First QC Date

October 28, 2021

Last Update Submit

November 22, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • above 18 years of age
  • receiving services in the municipality due to mental health and or addiction problems.

You may not qualify if:

  • visual and hearing impairment, neurological disorders, and mental retardation \[score ≤70 on the Test of Intelligence\].

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innlandet Hospital Trust

Brumunddal, 2381, Norway

Location

MeSH Terms

Conditions

Substance-Related DisordersMental Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Lars Lien, MD, Ph.d

    Sykehuset Innlandet HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2021

First Posted

December 16, 2022

Study Start

March 1, 2022

Primary Completion

August 31, 2023

Study Completion

December 1, 2024

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations