Trial Outcomes & Findings for Psychophysiologic Predictors of Post-deployment Mental Health Outcomes (NCT NCT00838006)
NCT ID: NCT00838006
Last Updated: 2020-07-02
Results Overview
The Post Traumatic Stress Disorder Checklist is based on Diagnostic Statistical Manual (DSM)-IV symptoms of PTSD. The minimum score is 17 and the maximum score is 85. Higher scores are associated with more severe symptoms and worse outcome.
COMPLETED
NA
426 participants
pre-deployment, 3-, and 12-months post-deployment
2020-07-02
Participant Flow
426 soldiers were enrolled and completed the pre-deployment assessment. Fo these, 342 were randomized and had at least one follow-up assessment.
Participant milestones
| Measure |
Heart Rate Variability Biofeedback Training
Heart rate variability biofeedback training and iPod with Breath Pacer app
heart rate variability biofeedback: Heart rate variability biofeedback,1 session plus handheld device
|
Cognitive Bias Modification Training
Cognitive bias modification training and iPod with cognitive bias training app
Cognitive bias modification training: Cognitive bias modification training - 1 session plus handheld device
|
Control Group
No additional resilience training and iPod with no resilience training apps
Sham Comparator: Subjects received iPod without a study app and no additional resilience training
|
|---|---|---|---|
|
Overall Study
STARTED
|
102
|
98
|
142
|
|
Overall Study
3-month Post-deployment Follow-up
|
92
|
80
|
135
|
|
Overall Study
COMPLETED
|
68
|
72
|
94
|
|
Overall Study
NOT COMPLETED
|
34
|
26
|
48
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Psychophysiologic Predictors of Post-deployment Mental Health Outcomes
Baseline characteristics by cohort
| Measure |
Cognitive Bias Modification
n=98 Participants
Soldiers randomized to Cognitive Bias Modification for Interpretation training arm
|
Heart Rate Variability Biofeedback
n=102 Participants
Soldiers randomized to Heart Rate Variability Biofeedback training arm
|
Control
n=142 Participants
Soldiers randomly assigned to Control group
|
Total
n=342 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
98 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
342 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
29.0 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
29.0 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
28.1 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
28.7 years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
314 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
98 participants
n=5 Participants
|
102 participants
n=7 Participants
|
142 participants
n=5 Participants
|
342 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: pre-deployment, 3-, and 12-months post-deploymentPopulation: participants completed baseline and at least one follow-up
The Post Traumatic Stress Disorder Checklist is based on Diagnostic Statistical Manual (DSM)-IV symptoms of PTSD. The minimum score is 17 and the maximum score is 85. Higher scores are associated with more severe symptoms and worse outcome.
Outcome measures
| Measure |
HRV Biofeedback
n=102 Participants
Soldiers randomized the heart rate variability biofeedback training arm
|
Cognitive Bias Modification Training
n=98 Participants
Soldiers randomized to the cognitive bias modification for interpretation training arm
|
Control
n=142 Participants
Soldiers randomized to the control arm
|
|---|---|---|---|
|
The PTSD Checklist - Military Version
Pre-deployment
|
22.2 units on a scale
Standard Deviation 6.6
|
23.7 units on a scale
Standard Deviation 8.4
|
23.8 units on a scale
Standard Deviation 9.6
|
|
The PTSD Checklist - Military Version
3-months Post-deployment
|
25.9 units on a scale
Standard Deviation 9.2
|
26.5 units on a scale
Standard Deviation 11.9
|
28.5 units on a scale
Standard Deviation 12.7
|
|
The PTSD Checklist - Military Version
12-month Post-deployment
|
24.5 units on a scale
Standard Deviation 9.2
|
24.3 units on a scale
Standard Deviation 8.6
|
23.9 units on a scale
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: pre-deployment, 3-, and 12-month post-deploymentThe PHQ-9 is a nine-item depression module that is based on DSM-IV criteria for major depression. The minimum score is 0 and the maximum score is 27. Higher scores indicate more severe depression or worse outcome.
Outcome measures
| Measure |
HRV Biofeedback
n=102 Participants
Soldiers randomized the heart rate variability biofeedback training arm
|
Cognitive Bias Modification Training
n=98 Participants
Soldiers randomized to the cognitive bias modification for interpretation training arm
|
Control
n=142 Participants
Soldiers randomized to the control arm
|
|---|---|---|---|
|
Patient Health Questionnaire (PHQ-9)
|
2.83 units on a scale
Standard Deviation 3.19
|
3.02 units on a scale
Standard Deviation 3.27
|
3.03 units on a scale
Standard Deviation 3.29
|
Adverse Events
HRV Biofeedback
Cognitive Bias Modification Training
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jeff Pyne, MD
Central Arkansas Veterans Healthcare System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place