Driving Distress Secondary to Trauma During DeploymentNCT01336764
Enhancing Emotion Regulation During Driving in OEF/OIF Veterans
A study testing Cognitive reappraisal and breathing retraining in people with Driving Distress Secondary to Trauma During Deployment, run by Palo Alto Veterans Institute for Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Driving Distress Secondary to Trauma During Deployment
- What is being tested?
- Cognitive reappraisal and breathing retraining
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304
About this study
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.
Read the 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.
- Being tested
- Cognitive reappraisal and breathing retraining, Control
- Keywords
- driving distress, veterans, OEF/OIF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive reappraisal and breathing retrainingBehavioural
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.
ControlBehavioural
Unguided listening to radio/music.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | individual coping self-statements and stimulus guided paced breathing. Receives: 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced Heart Rate During Driving (Aggregated Over Sessions)
averaged over sessions
Measured: during 60-90 min driving intervention over the 3 intervention visits which were approximately one week apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Driving Distress Secondary to Trauma During DeploymentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- VA Palo Alto Health Care System
- Responsible party
- Principal investigator, Steven Woodward, Stanford University
- Investigators
- Steven H Woodward, PhD, Principal investigator, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336764
- Sponsor's protocol ID
- WOS0016AGG
- Status last verified
- Apr 2017
- First submitted
- 5 Apr 2011
- Last updated
- 16 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Emotion Regulation During Driving in OEF/OIF Veterans
- ClinicalTrials.gov ID
- NCT01336764
- Acronym / sponsor ID
- WOS0016AGG
- Keywords
- driving distress, veterans, OEF/OIF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- VA Palo Alto Health Care System
- Study start
- Apr 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Apr 2011 (estimated)
- Results
- Posted 16 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Behavioral: Cognitive reappraisal and breathing retrainingindividual coping self-statements and stimulus guided paced breathing. |
| Control | Sham comparator | Behavioral: ControlCoping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive reappraisal and breathing retrainingThey 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. | Behavioural | Active |
| ControlUnguided listening to radio/music. | Behavioural | Control |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven H Woodward, PhD principal investigator
VA Palo Alto Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive reappraisal and breathing retraining in people with Driving Distress Secondary to Trauma During Deployment, run by Palo Alto Veterans Institute for Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017.