Clinical trial NCT01336764: Enhancing Emotion Regulation During Driving in OEF/OIF Veterans
Official title: Enhancing Emotion Regulation During Driving in OEF/OIF Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Driving Distress Secondary to Trauma During Deployment
Keywords: driving distress
veterans
OEF/OIF
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
Collaborators: name: VA Palo Alto Health Care System
First posted: 2011-04-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduced Heart Rate During Driving (Aggregated Over Sessions)
timeFrame: during 60-90 min driving intervention over the 3 intervention visits which were approximately one week apart
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
affiliation: VA Palo Alto Health Care System
name: Steven H Woodward, PhD
role: PRINCIPAL_INVESTIGATOR
References: