Enhancing Emotion Regulation During Driving in OEF/OIF Veterans

Driving Distress Secondary to Trauma During Deployment Clinical Trial

Official title:

Enhancing Emotion Regulation During Driving in OEF/OIF Veterans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01336764
• Other study ID #: 18680
• Status: Recruiting
• Phase: N/A
• First received: April 5, 2011
• Last updated: April 18, 2011
• Start date: April 2011
• Est. completion date: April 2012

Study information

• Verified date: April 2011
• Source: Stanford University
• Contact: Abby Haile, PsyD
• Phone: 650-614-9800
• Email: abby.haile[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Many U.S. military personnel are returning from Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) deployments with histories of trauma while driving in military vehicles. The proposed project aims to develop and test a rehabilitative technology aimed at enhancing emotion regulation and reducing operator-related risk during civilian driving.

Description:

The driving exercises to be used are based upon standard Veterans Affairs-based driver assessments which have a well-established safety record and have been applied to a wide-range of medically-related and post-deployment driving issues.

Specifically, the driving exercises will embed a test-intervene-test session plan within a structured hierarchy of four progressively more challenging civilian driving tasks administered on successive weeks. Participants will drive local roads and highways familiar to Veterans Affairs - Palo Alto Health Care System Certified Driving Rehabilitation Specialists (CDRS). These courses have known characteristics as regards civilian driving challenges and OEF/OIF-relevant "trigger" stimuli. Graduation from one course to the next will take place only with permission from the CDRS who has accompanied the participant on the prior exercise. Based upon their self-reports of driving-related distress, we expect such distress to arise during the driving exercises. At such times, participants will be instructed to park in the next available safe parking location. They will be induced to rapidly achieve reduced autonomic arousal through use of a graphics-rich biofeedback procedure and simultaneously engage in the generation and rehearsal of cognitive reappraisal scripts under the coaching of project therapist also in the vehicle. These individualized procedures are expected to quickly lower emotional reactivity to subjectively adverse driving events and conditions. The participant will then drive the course a second time. Each session will finish with a graphical comparison of pre- and post-intervention vehicle and control surface movement parameters, visual attentional control, autonomic arousal and subjective driving distress.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Driving-related distress secondary to conditions of OEF/OIF deployment

2. Possesses valid driver's license

3. Owns vehicle registered in his/her name

4. Vehicle currently insured in his/her name

5. Drives regularly (e.g. to regularly scheduled activities such as work or school)

6. Drives to all driving rehabilitation appointments

Exclusion Criteria:

1. Any moving violations since discharge from the military

2. Any central nervous system injury or disease

3. Psychotic disorder and/or any psychotic signs or symptoms

4. Current alcohol or substance abuse/dependence (required answer: "yes" or "no", only)

5. Severe Post-traumatic Stress Disorder (as indicated by a PTSD Checklist (PCL) score greater than 60)

6. Severe Depression(as indicated by a Beck Depression Inventory-II score greater than 28)

7. Amputation or restricted mobility of any limb

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Driving Distress Secondary to Trauma During Deployment

Intervention

Behavioral:
• Cognitive reappraisal and breathing retraining
They will be induced to rapidly achieve reduced autonomic arousal through use of a graphics-rich biofeedback procedure and simultaneously engage in the generation and rehearsal of cognitive reappraisal scripts under the coaching of project therapist also in the vehicle.
• Control
Unguided listening to radio/music.

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	VA Palo Alto Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved Driving Behavior	reduced mean square successive differences of steering wheel position during driving within and across sessions; reduced peak lateral and longitudinal acceleration within and across sessions; reduced standard deviation of visual fixation durations within and across sessions	during 60-90min driving intervention, there will be 3 intervention visits	No