- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04820634
Using Virtual Reality to Improve Job Reentry in Adults With TBI
March 19, 2024 updated by: Kessler Foundation
The purpose of this research is to investigate the effectiveness of virtual reality (VR) to improve job reentry skills in individuals with TBI.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The current study will examine a virtual reality (VR) intervention entitled "Virtual Reality Job Interview Training (VR-JIT)" which targets social competency skills needed for successful job interviewing, and its efficacy when applied to individuals with traumatic brain injury (TBI).
Preliminary evidence suggests that the VR-JIT is successful in individuals with autism spectrum disorder and schizophrenia in improving interview abilities.
However, the efficacy of VR-JIT has not been evaluated in TBI populations.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Helen Genova, Ph.D.
- Phone Number: 973-324-8390
- Email: hgenova@kesslerfoundation.org
Study Locations
-
-
New Jersey
-
East Hanover, New Jersey, United States, 07936
- Recruiting
- Kessler Foundation
-
Contact:
- Nancy Moore, MA
- Phone Number: 973-323-8450
- Email: nmoore@kesslerfoundation.org
-
Principal Investigator:
- Helen Genova, Ph.D.
-
Contact:
- Katarina Reduzzi, BA
- Email: kreduzzi@kesslerfoundation.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- I am between the ages of 18 and 65.
- I have a diagnosis with moderate to severe TBI.
- I am at least one year post injury.
- I am able to speak and read English fluently.
Exclusion Criteria:
- I have a history of multiple sclerosis, stroke, seizures or another neurological injury or disease in the past (like brain tumor or epilepsy).
- I have a history of significant psychiatric illness (like bipolar disorder, schizophrenia or psychosis).
- I am currently taking steroids and/or benzodiazepines as determined by study staff review of my medications.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VR-JIT
In this arm, participants would participate in simulated interviews utilizing a software program and virtual interviewer, once a week for 90 minutes.
|
The treatment group (TX) will complete 7 sessions of VR-JIT (1 sessions per week for 7 weeks), designed to teach the skills & concepts of job interviews.
Sessions are approximately 90 minutes long.
|
|
Placebo Comparator: Wonderworks
In this arm, participants would participate in a similar intervention, also once a week for 90 minutes.
However, in this arm, the intervention would be in a virtual office environment completing office tasks.
|
The control group (CT) will complete 7 sessions of Wonderworks (1 session per week for 7 weeks) using skills in an office environment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Mock Job Interview Score at 1 month
Time Frame: 1 month
|
Participants will complete a mock job interview at follow-up which will be compared to their initial interview and rated by blinded assessors on their job interview performance.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: John DeLuca, Ph.D., Lab Director
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 12, 2019
Primary Completion (Estimated)
July 28, 2024
Study Completion (Estimated)
July 28, 2024
Study Registration Dates
First Submitted
February 3, 2021
First Submitted That Met QC Criteria
March 26, 2021
First Posted (Actual)
March 29, 2021
Study Record Updates
Last Update Posted (Actual)
March 20, 2024
Last Update Submitted That Met QC Criteria
March 19, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-1090-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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