Trial Outcomes & Findings for Enhancing Emotion Regulation During Driving in OEF/OIF Veterans (NCT NCT01336764)

Results Overview

averaged over sessions

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

during 60-90 min driving intervention over the 3 intervention visits which were approximately one week apart

Results posted on

2017-06-16

Participant milestones
Measure	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.	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.
Overall Study STARTED	12	10
Overall Study COMPLETED	7	5
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	5	5

Enhancing Emotion Regulation During Driving in OEF/OIF Veterans

Baseline characteristics by cohort
Measure	Active n=12 Participants 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.	Control n=10 Participants Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music. Control: Unguided listening to radio/music.	Total n=22 Participants Total of all reporting groups
Age, Customized age>/=18 years	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants

Timeframe: during 60-90 min driving intervention over the 3 intervention visits which were approximately one week apart

averaged over sessions

Outcome measures
Measure	Active n=7 Participants 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.	Control n=5 Participants Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music. Control: Unguided listening to radio/music.
Reduced Heart Rate During Driving (Aggregated Over Sessions)	3.21 beats per minute Standard Deviation 5	9.0 beats per minute Standard Deviation 5

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 22 deaths

Adverse event data not reported

Adverse event data not reported

National Center for PTSD

Phone: 650-493-5000