Using Virtual Reality to Improve Job Reentry in Adults With TBI

Sponsor

Kessler Foundation (Other)

Overall Status

Recruiting

CT.gov ID

NCT04820634

Collaborator

(none)

Enrollment

Location

Arms

31.5

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research is to investigate the effectiveness of virtual reality (VR) to improve job reentry skills in individuals with TBI.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury	Other: Virtual Reality Job Interview Training Other: Wonderworks	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Using Virtual Reality to Improve Job Reentry in Adults With TBI

Actual Study Start Date :

Dec 12, 2019

Anticipated Primary Completion Date :

Jul 28, 2021

Anticipated Study Completion Date :

Jul 28, 2022

Arms and Interventions

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.	Other: Virtual Reality Job Interview Training 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.	Other: Wonderworks The control group (CT) will complete 7 sessions of Wonderworks (1 session per week for 7 weeks) using skills in an office environment.

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.

Other: Virtual Reality Job Interview Training

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.

Other: Wonderworks

The control group (CT) will complete 7 sessions of Wonderworks (1 session per week for 7 weeks) using skills in an office environment.

Outcome Measures

Primary Outcome Measures

Change in Mock Job Interview Score at 1 month [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kessler Foundation	East Hanover	New Jersey	United States	07936

Sponsors and Collaborators

Kessler Foundation

Investigators

Study Director: Nancy Chiarvalloti, Ph.D., Lab Director

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kessler Foundation

ClinicalTrials.gov Identifier:

NCT04820634

Other Study ID Numbers:

R-1090-19

First Posted:

Mar 29, 2021

Last Update Posted:

Mar 29, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Brain Injuries

Brain Injuries, Traumatic

Study Results

No Results Posted as of Mar 29, 2021