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Using Virtual Reality to Improve Job Reentry in Adults With TBI

Primary Purpose

Traumatic Brain Injury

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Virtual Reality Job Interview Training

Wonderworks

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Kessler FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VR-JIT

Wonderworks

Arm Description

In this arm, participants would participate in simulated interviews utilizing a software program and virtual interviewer, once a week for 90 minutes.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04820634

First Posted

February 3, 2021

Last Updated

October 12, 2022

Sponsor

Kessler Foundation

1. Study Identification

Unique Protocol Identification Number

NCT04820634

Brief Title

Using Virtual Reality to Improve Job Reentry in Adults With TBI

Official Title

Using Virtual Reality to Improve Job Reentry in Adults With TBI

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 12, 2019 (Actual)

Primary Completion Date

July 28, 2023 (Anticipated)

Study Completion Date

July 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kessler Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Brain Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

VR-JIT

Arm Type

Experimental

Arm Description

In this arm, participants would participate in simulated interviews utilizing a software program and virtual interviewer, once a week for 90 minutes.

Arm Title

Wonderworks

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Virtual Reality Job Interview Training

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Wonderworks

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Mock Job Interview Score at 1 month

Description

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.

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Helen Genova, Ph.D.

Phone

973-324-8390

hgenova@kesslerfoundation.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nancy Chiarvalloti, Ph.D.

Organizational Affiliation

Lab Director

Official's Role

Study Director

Facility Information:

Facility Name

Kessler Foundation

City

East Hanover

State/Province

New Jersey

ZIP/Postal Code

07936

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nancy Moore, MA

Phone

973-323-8450

nmoore@kesslerfoundation.org

First Name & Middle Initial & Last Name & Degree

Jimmy Morecraft, BA

Phone

973-323-3685

jmorecraft@kesslerfoundation.org

First Name & Middle Initial & Last Name & Degree

Helen Genova, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Using Virtual Reality to Improve Job Reentry in Adults With TBI

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