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Occupational Therapy Driving Intervention (OT-DI) for Post-Traumatic Stress Disorder

N/A

Waitlist Available

Led By Sherrilene Classen, PhD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up changes in baseline at months 2 and 5

Awards & highlights

Study Summary

This trialstudies driving ability in 260 Combat Veterans to see if Occupational Therapy Driving Intervention can help reduce driving errors.

Eligible Conditions

Traumatic Brain Injury
Post-Traumatic Stress Disorder

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ changes in baseline at months 2 and 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~changes in baseline at months 2 and 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and changes in baseline at months 2 and 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Simulator driving errors changes within the experimental and control groups at baseline, months 2 and 5

Secondary outcome measures

On-road driving errors changes within the experimental and control groups at baseline and month 5

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Experimental GroupExperimental Treatment8 Interventions

Participants in this group will have the following performed: Institute of Mobility Activity and Participation's clinical battery tests and a simulated driving tests, a Brief Driving Behavior Interview, Propensity for Angry Driving Scale, Clinical Driving Assessment, Community Integration Questionnaire, Fitness-to-Drive Screening Measure(FTDS), and a Satisfaction with Life Questionnaire. Occupational Therapy Driving Intervention (OT-DI) consisting of three x 1 hour sessions to review explicit driving errors, strategies to mitigate errors and receiving feedback from the evaluator after driving the simulator.

Group II: Simulator-drives Evaluation GroupActive Control1 Intervention

This group will comprise of 30 Combat Veterans who will be drawn outside of the randomized experimental and and control groups participants. This group will only perform simulator driving triggers evaluation

Group III: Control GroupActive Control8 Interventions

Participants in this group will have the following performed: Institute of Mobility Activity and Participation's clinical battery tests and a simulated driving evaluation, a Brief Driving Behavior Interview, Propensity for Angry Driving Scale, Clinical Driving Assessment, Community Integration Questionnaire, Fitness-to-Drive Screening Measure (FTDS), and a Satisfaction with Life Questionnaire. Driving Safety Education by a traffic safety professional, three x 1 hour sessions to discuss traffic safety rules regarding person, vehicle, environmental factors.

Group IV: Caregiver Control GroupActive Control1 Intervention

Caregiver control group will fill out a Fitness-to-Drive Screening Measure (FTDS) questionnaire at baseline and at the end of the study.

Group V: Caregiver Experimental GroupActive Control1 Intervention

Caregivers of the experimental group will fill out a Fitness-to-Drive Screening Measure (FTDS) questionnaire at baseline and at the end of the study.

Group VI: On-road driving GroupActive Control1 Intervention

A subset of 30 Combat Veterans will be drawn from the control group (15 no.) and experimental group (15 no.). This group of Combat Veterans will will undergo an on-road driving test at baseline and month 5

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Driving Behavior Interview

2016

N/A

~130

Propensity for Angry Driving Scale

2016

N/A

~130

Satisfaction with Life

2016

N/A

~60

Fitness-to-Drive Screening Measure (FTDS)

2016

N/A

~60

Simulated Driving Evaluation

2016

N/A

~60

Occupational Therapy Driving Intervention (OT-DI)

2016

N/A

~60

Community Integration Questionnaire

2016

N/A

~130

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,340 Previous Clinical Trials

715,647 Total Patients Enrolled

United States Department of DefenseFED

863 Previous Clinical Trials

227,574 Total Patients Enrolled

VA Office of Research and DevelopmentFED

1,609 Previous Clinical Trials

3,306,371 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications must potential participants satisfy to enroll in this research project?

"The eligibility criteria for this medical trial require participants to have suffered a brain injury and be aged between 18-85. This particular clinical experiment is designed to recruit 58 willing candidates in total."

Answered by AI

Is the current study recruiting participants that are younger than seventy years of age?

"This medical trial is open to all individuals between 18 and 85 years old. For younger or older patients, 105 trials are available for those under 18 and 542 for seniors over 65."

Answered by AI

Are there any open vacancies in this clinical investigation?

"According to clinicaltrials.gov, this medical trial is no longer accepting patients. It was initially posted on December 1st 2016 and lastly updated on October 24th 2022; while the study has concluded recruitment, there are currently 707 other trials that remain in active enrollment status."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effectiveness of a Driving Intervention on Safe Community Mobility for Returning Combat Veterans

2016. "Effectiveness of a Driving Intervention on Safe Community Mobility for Returning Combat Veterans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02765672.