Enhancing Emotion Regulation During Driving in OEF/OIF Veterans
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|ClinicalTrials.gov Identifier: NCT01336764|
Recruitment Status : Completed
First Posted : April 18, 2011
Results First Posted : June 16, 2017
Last Update Posted : June 16, 2017
|Condition or disease||Intervention/treatment|
|Driving Distress Secondary to Trauma During Deployment||Behavioral: Cognitive reappraisal and breathing retraining Behavioral: Control|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Masking Description:||Physical separation of Care Provider during self-administration of intervention|
|Official Title:||Enhancing Emotion Regulation During Driving in OEF/OIF Veterans|
|Study Start Date :||April 2011|
|Primary Completion Date :||December 2014|
|Study Completion Date :||December 2014|
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.
Unguided listening to radio/music.
- 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
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
|United States, California|
|VA Palo Alto Health Care System|
|Palo Alto, California, United States, 94304|
|Principal Investigator:||Steven H Woodward, PhD||VA Palo Alto Health Care System|