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| Name | Class |
|---|---|
| VA Palo Alto Health Care System | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | individual coping self-statements and stimulus guided paced breathing. |
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| Control | Sham Comparator | Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven H Woodward, PhD | VA Palo Alto Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System | Palo Alto | California | 94304 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | individual coping self-statements and stimulus guided paced breathing. 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. |
| FG001 | Control | Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music. Control: Unguided listening to radio/music. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | individual coping self-statements and stimulus guided paced breathing. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reduced Heart Rate During Driving (Aggregated Over Sessions) | averaged over sessions | Posted | Mean | Standard Deviation | beats per minute | during 60-90 min driving intervention over the 3 intervention visits which were approximately one week apart |
|
Entire study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active | individual coping self-statements and stimulus guided paced breathing. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven H. Woodward, PhD | National Center for PTSD | 650-493-5000 | 22111 | steve.woodward@va.gov |
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Physical separation of Care Provider during self-administration of intervention
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| Control | Behavioral | Unguided listening to radio/music. |
|
| BG001 | Control | Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music. Control: Unguided listening to radio/music. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 0 |
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| 12 |
| 0 |
| 12 |
| EG001 | Control | Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music. Control: Unguided listening to radio/music. | 22 | 22 | 0 | 10 | 0 | 10 |
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