Enhancing Emotion Regulation During Driving in OEF/OIF Veterans

NCT ID: NCT01336764

Last Updated: 2017-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2014-12-31

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.

Conditions

Driving Distress Secondary to Trauma During Deployment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active

individual coping self-statements and stimulus guided paced breathing.

Group Type: EXPERIMENTAL

Cognitive reappraisal and breathing retraining

Intervention Type: BEHAVIORAL

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

Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music.

Group Type: SHAM_COMPARATOR

Control

Intervention Type: BEHAVIORAL

Unguided listening to radio/music.

Interventions

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.

Intervention Type: BEHAVIORAL

Control

Unguided listening to radio/music.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Palo Alto Health Care System

FED

Sponsor Role: collaborator

Palo Alto Veterans Institute for Research

OTHER

Sponsor Role: lead

Responsible Party

Steven Woodward

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven H Woodward, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System

Locations

VA Palo Alto Health Care System

Palo Alto, California, United States

Countries

United States

Other Identifiers

WOS0016AGG

Identifier Type: -

Identifier Source: org_study_id