Enhancing Emotion Regulation During Driving in OEF/OIF Veterans

NCT01336764 | Completed Results

• 1 other identifier: WOS0016AGG
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Driving Distress Secondary to Trauma During Deployment

Keywords

driving distress; veterans; OEF/OIF

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Active

EXPERIMENTAL

individual coping self-statements and stimulus guided paced breathing.

Behavioral: Cognitive reappraisal and breathing retraining

Control

SHAM COMPARATOR

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

Behavioral: Control

Interventions

Cognitive reappraisal and breathing retraining 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.

Active

Control BEHAVIORAL

Unguided listening to radio/music.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Driving-related distress secondary to conditions of OEF/OIF deployment
• Possesses valid driver's license
• Owns vehicle registered in his/her name
• Vehicle currently insured in his/her name
• Drives regularly (e.g. to regularly scheduled activities such as work or school)
• Drives to all driving rehabilitation appointments

You may not qualify if:

• Any moving violations since discharge from the military
• Any central nervous system injury or disease
• Psychotic disorder and/or any psychotic signs or symptoms
• Current alcohol or substance abuse/dependence (required answer: "yes" or "no", only)
• Severe Post-traumatic Stress Disorder (as indicated by a PTSD Checklist (PCL) score greater than 60)
• Severe Depression(as indicated by a Beck Depression Inventory-II score greater than 28)
• Amputation or restricted mobility of any limb

Sponsors & Collaborators

• Palo Alto Veterans Institute for Research: lead
• VA Palo Alto Health Care System: collaborator

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Results Point of Contact

• Title: Steven H. Woodward, PhD
• Organization: National Center for PTSD

steve.woodward@va.gov

650-493-5000

Study Officials

• Steven H Woodward, PhD

  VA Palo Alto Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Physical separation of Care Provider during self-administration of intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 5, 2011
• First Posted: April 18, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 16, 2017
• Results First Posted: June 16, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)