Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-01-05 @ 12:31 AM
Study NCT ID:
NCT05653167
Status:
UNKNOWN
Last Update Posted:
2023-11-28
First Post:
2021-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VR as a Facilitator for Participation in Society Among Persons With MHD/SUD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-24', 'size': 1395909, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-12-06T15:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-22', 'studyFirstSubmitDate': '2021-10-28', 'studyFirstSubmitQcDate': '2022-12-07', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Practical and social functioning', 'timeFrame': '2 hours', 'description': 'measured by the Practical and Social Functioning Scale (PSF)'}, {'measure': 'Social inclusion', 'timeFrame': '2 hours', 'description': 'Measured by the Social and Community Opportunities Profile (SCOPE)'}, {'measure': 'Barriers for participation in society', 'timeFrame': 'duration of the in-depth interview', 'description': 'This will be assessed within in-depth interviews'}, {'measure': 'Facilitators for participation in society', 'timeFrame': 'duration of the in-depth interview', 'description': 'This will be assessed within in-depth interviews'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Substance Use Disorders', 'Mental Disorder']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* above 18 years of age\n* receiving services in the municipality due to mental health and or addiction problems.\n\nExclusion Criteria:\n\n-visual and hearing impairment, neurological disorders, and mental retardation \\[score ≤70 on the Test of Intelligence\\].'}, 'identificationModule': {'nctId': 'NCT05653167', 'acronym': 'SOPATMEDVR1', 'briefTitle': 'VR as a Facilitator for Participation in Society Among Persons With MHD/SUD', 'organization': {'class': 'OTHER', 'fullName': 'Sykehuset Innlandet HF'}, 'officialTitle': 'Complex Socio-emotional Learning in VR-based Simulation Training Among Persons With Mental Health and/or Substance Use Disorders"', 'orgStudyIdInfo': {'id': '326773VR_WP1'}}, 'contactsLocationsModule': {'locations': [{'zip': '2381', 'city': 'Brumunddal', 'country': 'Norway', 'facility': 'Innlandet Hospital Trust', 'geoPoint': {'lat': 60.88095, 'lon': 10.93948}}], 'overallOfficials': [{'name': 'Lars Lien, MD, Ph.d', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sykehuset Innlandet HF'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sykehuset Innlandet HF', 'class': 'OTHER'}, 'collaborators': [{'name': 'Inland Norway University of Applied Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}