Traumatic Brain InjuryNCT04820634
Using Virtual Reality to Improve Job Reentry in Adults With TBI
A study testing Virtual Reality Job Interview Training and Wonderworks in people with Traumatic Brain Injury, run by Kessler Foundation at 1 site in United States.
Trial summary
The purpose of this research is to investigate the effectiveness of virtual reality (VR) to improve job reentry skills in individuals with TBI. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Virtual Reality Job Interview Training and Wonderworks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2019to 28 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
East Hanover, New Jersey, 07936
Nancy Moore, MA, 973-323-8450, nmoore@kesslerfoundation.org
Katarina Reduzzi, BA, kreduzzi@kesslerfoundation.org
About this study
The purpose of this research is to investigate the effectiveness of virtual reality (VR) to improve job reentry skills in individuals with TBI.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Virtual Reality Job Interview Training, Wonderworks
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Job Interview TrainingOther
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.
WonderworksOther
The control group (CT) will complete 7 sessions of Wonderworks (1 session per week for 7 weeks) using skills in an office environment.
| Study group | Role | What they receive |
|---|---|---|
| VR-JIT | Experimental | In this arm, participants would participate in simulated interviews utilizing a software program and virtual interviewer, once a week for 90 minutes. Receives: Other: Virtual Reality Job Interview Training |
| Wonderworks | Placebo comparator | 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. Receives: Other: Wonderworks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mock Job Interview Score at 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start12 Dec 2019
- Primary completion28 Jul 2024 (estimated)
- Study completion28 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John DeLuca, Ph.D., Study chair, Lab Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820634
- Sponsor's protocol ID
- R-1090-19
- Status last verified
- Mar 2024
- First submitted
- 3 Feb 2021
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Virtual Reality to Improve Job Reentry in Adults With TBI
- ClinicalTrials.gov ID
- NCT04820634
- Acronym / sponsor ID
- R-1090-19
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 28 Jul 2024 (estimated)
- Study completion
- 28 Jul 2024 (estimated)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to investigate the effectiveness of virtual reality (VR) to improve job reentry skills in individuals with TBI.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR-JIT | Experimental | Other: Virtual Reality Job Interview TrainingIn this arm, participants would participate in simulated interviews utilizing a software program and virtual interviewer, once a week for 90 minutes. |
| Wonderworks | Placebo comparator | Other: WonderworksIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Job Interview TrainingThe 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. | Other | VR-JIT |
| WonderworksThe control group (CT) will complete 7 sessions of Wonderworks (1 session per week for 7 weeks) using skills in an office environment. | Other | Wonderworks |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John DeLuca, Ph.D. study chair
Lab Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Job Interview Training and Wonderworks in people with Traumatic Brain Injury, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helen Genova, Ph.D. (973-324-8390, hgenova@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mock Job Interview Score at 1 month (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.