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Enhancing Emotion Regulation During Driving in OEF/OIF Veterans

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01336764
First Posted: April 18, 2011
Last Update Posted: June 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
VA Palo Alto Health Care System
Information provided by (Responsible Party):
Steven Woodward, Stanford University
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description:
Physical separation of Care Provider during self-administration of intervention
Primary Purpose: Treatment
Official Title: Enhancing Emotion Regulation During Driving in OEF/OIF Veterans

Further study details as provided by Steven Woodward, Stanford University:

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


Enrollment: 22
Study Start Date: April 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01336764


Locations
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Palo Alto Veterans Institute for Research
VA Palo Alto Health Care System
Investigators
Principal Investigator: Steven H Woodward, PhD VA Palo Alto Health Care System
  More Information

Responsible Party: Steven Woodward, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01336764     History of Changes
Other Study ID Numbers: WOS0016AGG
First Submitted: April 5, 2011
First Posted: April 18, 2011
Results First Submitted: February 16, 2017
Results First Posted: June 16, 2017
Last Update Posted: June 16, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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