Enhancing Emotion Regulation During Driving in OEF/OIF Veterans

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
VA Palo Alto Health Care System
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01336764
First received: April 5, 2011
Last updated: April 18, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Driving Distress Secondary to Trauma During Deployment
Behavioral: Cognitive reappraisal and breathing retraining
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Enhancing Emotion Regulation During Driving in OEF/OIF Veterans

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Improved Driving Behavior [ Time Frame: during 60-90min driving intervention, there will be 3 intervention visits ] [ Designated as safety issue: No ]
    1. reduced mean square successive differences of steering wheel position during driving within and across sessions
    2. reduced peak lateral and longitudinal acceleration within and across sessions
    3. reduced standard deviation of visual fixation durations within and across sessions


Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01336764

Contacts
Contact: Abby Haile, PsyD 650-614-9800 abby.haile@va.gov
Contact: Steve Woodward, PhD 650-493-5000 ext 22111 steve.woodward@va.gov

Locations
United States, California
VA Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304
Principal Investigator: Steven Woodward, PhD         
Sponsors and Collaborators
Stanford University
VA Palo Alto Health Care System
Investigators
Principal Investigator: Steven Woodward, PhD VA Palo Alto Health Care System
  More Information

No publications provided

Responsible Party: Steven Woodward, PhD, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT01336764     History of Changes
Other Study ID Numbers: 18680
Study First Received: April 5, 2011
Last Updated: April 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
driving distress
veterans
OEF/OIF

ClinicalTrials.gov processed this record on July 22, 2014