- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07114887
- Original Trial
Virtual Reality for Vocational Recovery (VR4VR)
Enhancing Vocational Support With a Virtual Reality Vocational Skills Building Application: Piloting VR4VR
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jennifer M Nicholas, PhD
- Phone Number: +61399669235
- Email: jennifer.nicholas@orygen.org.au
Study Contact Backup
- Name: James Whiting
- Phone Number: +61399669173
- Email: james.whiting@orygen.org.au
Study Locations
-
-
New South Wales
-
Orange, New South Wales, Australia, 2800
- Veritas House
-
Contact:
- Haylee Lepaio
- Phone Number: +61437 415 906
- Email: Haylee.Lepaio@veritashouse.org.au
-
-
Victoria
-
Melbourne, Victoria, Australia, 3052
- Orygen Specialist Services
-
Contact:
- Patrik Shah
- Phone Number: +61460853046
- Email: pratik.shah@orygen.org.au
-
-
Western Australia
-
Perth, Western Australia, Australia, 6056
- Youth Focus Burswood
-
Contact:
- Katie Llewell
- Phone Number: +618 9274 8860
- Email: Katie.Llewell@headspacemidland.com.au
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
A young person participant will be considered eligible for inclusion in this study if:
- They are aged 18-25 seeking vocational support at participating vocational support programs
- Have a named care-coordinator or key worker
- Comfortable using a VR headset
- Consent to recording of interview for transcription
Exclusion Criteria:
- They lack fluency in English (spoken and written), since this is required to understand participate in the VR intervention;
- They have a known diagnosis of a moderate intellectual disability, due to some of the content delivered during the intervention requiring a certain level of understanding.
- As the therapy uses audio and visual means of communication, participants with impairments so severe that they cannot hear instructions, or are unable to see the virtual reality environments, cannot participate. Mild impairments can be accommodated, as sound volume can be turned up, and the Meta Quest headband is used to comfortably use glasses with the headset.
A vocational specialist or staff participant will be considered eligible for inclusion in this study if:
- Presently work within a vocational program and hold a caseload of young people
- Have worked with at least 5 young people within a vocational intervention.
- Sufficient command of the English language
- Consent to audio recording of interview
No exclusion criteria
A staff participant will be considered eligible for inclusion in this study if:
- Presently work within a role supporting a vocational program
- Sufficient command of the English language
- Consent to audio recording of interview
No exclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual reality for vocational recovery
Within standard vocational care, young people will receive a three-session (optional 4th) virtual reality training intervention to address key challenges associated with educational and employment attainment and maintenance. Session 1: Approaching potential employers Session 2: Asking for reasonable adjustments Session 3: Managing customers |
Intervention is an immersive virtual reality (VR) intervention, delivered through a VR headset, supported by a trained vocational specialist.
Intervention content was co-designed with young people with mental health and vocational challenges, and vocational specialists with experiencing supporting this population.
Content was guided by goals of vocational programs, including Individual Placement and Support.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility - recruitment rates
Time Frame: 6 months post intervention commencement
|
Rates of recruitment for the study (young people and vocational and service staff) based on an audit of study enrolment
|
6 months post intervention commencement
|
|
Acceptability
Time Frame: 6 weeks post intervention commencement
|
Acceptability as measured by the Theoretical Framework of Acceptability Measure delivered to young people and vocational specialists.
Total mean score across the 7 TFA items will be reported, on a scale of 1 to 5, with 5 indicating greater acceptability.
|
6 weeks post intervention commencement
|
|
Safety - adverse events
Time Frame: 6 weeks post intervention commencement
|
The number of serious adverse events specifically related to the intervention or trial
|
6 weeks post intervention commencement
|
|
Feasibility - consent rates
Time Frame: 6 months post intervention commencement
|
Rates of consent for the study (young people and vocational and service staff) based on an audit of consent logs
|
6 months post intervention commencement
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility - attendance rates of assessments and sessions
Time Frame: 6 weeks post intervention commencement
|
Via audit of attendance logs
|
6 weeks post intervention commencement
|
|
Feasibility - delivery of VR4VR
Time Frame: 6 months post intervention commencement
|
Proportion of trained vocational specialists who use the intervention during the trial period
|
6 months post intervention commencement
|
|
Feasibility - VR utilisation
Time Frame: 6 months post intervention commencement
|
Proportion of sessions within the intervention period in which VR was used within intervention sessions.
|
6 months post intervention commencement
|
|
Acceptability - cybersickness
Time Frame: 6 weeks post intervention commencement
|
Cybersickness as measured by the Simulator Sickness Questionnaire.
16 items across three domains, nausea, Oculomotor and disorientation are summed to produce a total score.
Items are scored on a scale from 0 to 3, with a higher score indicating greater cybersickness symptoms.
|
6 weeks post intervention commencement
|
|
Acceptability - VR presence
Time Frame: 6 weeks post intervention commencement
|
Sense of 'being there' within the VR environment measured using the Igroup Presence Questionnaire.
Total score is calculated by summing all items.
Items are rated on a scale of -3 to 3, with a higher scoring indicating greater sense of presence.
|
6 weeks post intervention commencement
|
|
Effectiveness - Social and occupational functioning
Time Frame: 6 weeks post intervention commencement
|
Young person functioning measured by the single item social and occupational functioning scale, ranging from 0 to 100, with lower scores indicating poorer functioning.
|
6 weeks post intervention commencement
|
|
Effectiveness - Occupational self-efficacy
Time Frame: 6 weeks post intervention commencement
|
Young person self-efficacy around employment measured by occupational self-efficacy scale.
Items rated on a scale tanging from 1 to 6, with higher vales reflecting higher occupational self-efficacy.
|
6 weeks post intervention commencement
|
|
Effectiveness - General self-efficacy
Time Frame: 6 weeks post intervention commencement
|
Young person self-efficacy using the general self-efficacy scale, to assess an individual's perceived generalised capabilities to respond to a variety of challenges and situations.
Scores range from 1-4 with highest scores indicating higher self-efficacy.
The total score is calculated by finding the sum of the all items.
|
6 weeks post intervention commencement
|
|
Feasibility - intervention implementation
Time Frame: up to 6 months post intervention commencement
|
Feasibility of Implementation Measure (completed by service leads and clinicians)
|
up to 6 months post intervention commencement
|
|
Vocational specialist confidence and competence
Time Frame: Immediately post-training
|
Purpose-built scale (no title or acronym) developed specifically for the current study capturing self-report vocational specialist confidence and competence using VR for vocational support.
The scale is 8 items, scored of a scale of 1 to 4. Higher score indicates a greater degree of competence with VR4VR.
|
Immediately post-training
|
|
Implementation - perceived barriers and enablers to use in practice
Time Frame: Through study completion an average of 6 months
|
Assessed through qualitative analysis of supervision meeting minutes with vocational specialists
|
Through study completion an average of 6 months
|
|
Implementation - perceived barriers and enablers to use in practice
Time Frame: Through study completion an average of 6 months
|
Assessed through qualitative analysis of research meeting minutes
|
Through study completion an average of 6 months
|
|
Implementation - perceived barriers and enablers to use in practice
Time Frame: Through study completion an average of 6 months
|
Assessed through qualitative analysis of post-intervention interviews focusing on participants' experiences of using the VR4VR intervention during vocational support.
|
Through study completion an average of 6 months
|
|
Feasibility - fidelity
Time Frame: 6 months post intervention commencement
|
Proportion of VR4VR sessions that are delivered per-protocol, assessed by the timing of sessions.
|
6 months post intervention commencement
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer Nicholas, PhD, University of Melbourne
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ORY-P05-24-31
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Mental Health Disorder
-
University Hospital, Strasbourg, FranceRecruitingMental Health DisorderFrance
-
Rutgers, The State University of New JerseyRecruiting
-
Virginia Commonwealth UniversityCompletedMental Health DisordersUnited States
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedMental Health DisordersCongo
-
Norwegian University of Science and TechnologySt. Olavs HospitalCompletedMental Health DisordersNorway
-
University of WarwickKing's College London; KU Leuven; University Hospital, Montpellier; Erasmus Medical... and other collaboratorsUnknownMental Health Disorder | Mental Health ImpairmentIreland, United Kingdom, Netherlands, Germany, Belgium, Croatia, France, Italy
-
York UniversityCanadian Institutes of Health Research (CIHR); North York General HospitalCompletedMental Health DisordersCanada
-
VA Boston Healthcare SystemUS Department of Veterans AffairsCompletedMental Health DisordersUnited States
-
Mindstate Design LabsCompleted
-
University of HaifaCompletedMental Health DisordersIsrael
Clinical Trials on Virtual reality for vocational recovery
-
King Salman Center for Disability ResearchCompleted
-
University of WashingtonNational Institute of General Medical Sciences (NIGMS)Completed
-
Yonsei UniversityTerminatedMedical EducationKorea, Republic of
-
Alexandria UniversityRecruitingPostoperative Pain | Abdominal Surgery | Postoperative Recovery | Length of Hospital StayEgypt
-
Emrah AyAtaturk University; Prof. Dr. Mağfiret KaşıkçıCompletedQuality of Life | Cough | Copd | Self Efficacy | Nursing CariesTurkey
-
University of MiamiThe Children's Trust, Miami FLCompletedAutism Spectrum Disorder | Social Anxiety Disorder | Specific PhobiaUnited States
-
Centre Hospitalier le MansRecruiting
-
Ziv HospitalRecruitingAnxiety | Episiotomy Wound | Perineum; InjuryIsrael
-
Hadassah Medical OrganizationUniversity of HaifaUnknown
-
Sheffield Hallam UniversityCompletedDysphagia | Virtual Reality | Treatment ComplianceUnited Kingdom