NCT04820634

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2024

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

4.6 years

First QC Date

February 3, 2021

Last Update Submit

March 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month

Study Arms (2)

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.

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.

Other: Wonderworks

Interventions

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.

VR-JIT

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

Wonderworks

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • John DeLuca, Ph.D.

    Lab Director

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2021

First Posted

March 29, 2021

Study Start

December 12, 2019

Primary Completion

July 28, 2024

Study Completion

July 28, 2024

Last Updated

March 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations