Enhancing Emotion Regulation During Driving in OEF/OIF Veterans

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.

Study Overview

• Status: Completed
• Conditions: Driving Distress Secondary to Trauma During Deployment
• Intervention / Treatment: Behavioral: Cognitive reappraisal and breathing retraining; Behavioral: Control

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • VA Palo Alto Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; individual coping self-statements and stimulus guided paced breathing.	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.
Sham Comparator: Control; Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music.	Behavioral: Control; Unguided listening to radio/music.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduced Heart Rate During Driving (Aggregated Over Sessions)	averaged over sessions	during 60-90 min driving intervention over the 3 intervention visits which were approximately one week apart

Collaborators and Investigators

• Sponsor: Palo Alto Veterans Institute for Research
• Collaborators: VA Palo Alto Health Care System
• Investigators: Principal Investigator: Steven H Woodward, PhD, VA Palo Alto Health Care System

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: April 5, 2011
• First Submitted That Met QC Criteria: April 14, 2011
• First Posted (Estimate): April 18, 2011

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: veterans; OEF/OIF; driving distress
• Other Study ID Numbers: WOS0016AGG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No