Post-traumatic Stress Disorder
Conditions
Keywords
post-traumatic stress disorder, post-deployment, prediction, prevention
Brief summary
The primary objectives of this proposal are to develop objective pre-deployment predictors of PTSD and test two pre-deployment resiliency interventions.
Detailed description
The primary objectives of this proposal are to develop objective pre-deployment predictors of PTSD and test two pre-deployment resiliency interventions. The objective predictors will be based on: 1) physiologic reactivity (heart rate, heart rate variability, eye blink startle, skin conductance) to virtual reality (VR) environments depicting common Operation Iraqi Freedom (OIF) or Operation Enduring Freedom (OEF) combat scenarios and 2) cognitive bias assessment using a recognition memory paradigm. We hypothesize that a model combining physiologic reactivity and cognitive bias predictors will be superior to either the physiologic reactivity or cognitive bias model alone for predicting post-deployment PTSD. We also will test two pre-deployment resiliency interventions: heart rate variability biofeedback and cognitive bias modification training that we have designed to target physiologic and cognitive responses to stress, respectively. We will compare the prevention interventions to a no intervention control group. We hypothesize that the prevalence of post-deployment PTSD will be lower in the intervention groups compared to the control group.
Interventions
DEVICEheart rate variability biofeedback
Heart rate variability biofeedback, 3 session plus handheld device
Cognitive bias modification training - 3 session plus handheld device
DEVICESham Comparator
Subjects received iPod without a study app and no additional resilience training
Sponsors
Biomedical Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Army National Guard members who are scheduled to deploy for OIF/OEF operations within the next 12 months, age 18 to 60, and willing to provide the name and phone number of at least one person to help locate the member for the follow-up assessments if necessary.
Exclusion criteria
* Implantable pacemaker or cardiac defibrillator * Unable to wear a virtual reality headset
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The PTSD Checklist - Military Version | pre-deployment, 3-, and 12-months post-deployment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) | pre-deployment, 3-, and 12-month post-deployment | The 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. |
Countries
United States
Participant flow
Pre-assignment details
426 soldiers were enrolled and completed the pre-deployment assessment. Fo these, 342 were randomized and had at least one follow-up assessment.
Participants by arm
| Arm | Count |
|---|---|
| Cognitive Bias Modification Soldiers randomized to Cognitive Bias Modification for Interpretation training arm | 98 |
| Heart Rate Variability Biofeedback Soldiers randomized to Heart Rate Variability Biofeedback training arm | 102 |
| Control Soldiers randomly assigned to Control group | 142 |
| Total | 342 |
Baseline characteristics
| Characteristic | Heart Rate Variability Biofeedback | Control | Cognitive Bias Modification | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 102 Participants | 142 Participants | 98 Participants | 342 Participants |
| Age, Continuous | 29.0 years STANDARD_DEVIATION 8.6 | 28.1 years STANDARD_DEVIATION 8.2 | 29.0 years STANDARD_DEVIATION 8.5 | 28.7 years STANDARD_DEVIATION 8.4 |
| Region of Enrollment United States | 102 participants | 142 participants | 98 participants | 342 participants |
| Sex: Female, Male Female | 16 Participants | 6 Participants | 6 Participants | 28 Participants |
| Sex: Female, Male Male | 86 Participants | 136 Participants | 92 Participants | 314 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 102 | 0 / 98 | 0 / 142 |
| other Total, other adverse events | 0 / 102 | 0 / 98 | 0 / 142 |
| serious Total, serious adverse events | 0 / 102 | 0 / 98 | 0 / 142 |
Outcome results
Primary
The PTSD Checklist - Military Version
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.
Time frame: pre-deployment, 3-, and 12-months post-deployment
Population: participants completed baseline and at least one follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HRV Biofeedback | The PTSD Checklist - Military Version | 3-months Post-deployment | 25.9 units on a scale | Standard Deviation 9.2 |
| HRV Biofeedback | The PTSD Checklist - Military Version | Pre-deployment | 22.2 units on a scale | Standard Deviation 6.6 |
| HRV Biofeedback | The PTSD Checklist - Military Version | 12-month Post-deployment | 24.5 units on a scale | Standard Deviation 9.2 |
| Cognitive Bias Modification Training | The PTSD Checklist - Military Version | 3-months Post-deployment | 26.5 units on a scale | Standard Deviation 11.9 |
| Cognitive Bias Modification Training | The PTSD Checklist - Military Version | Pre-deployment | 23.7 units on a scale | Standard Deviation 8.4 |
| Cognitive Bias Modification Training | The PTSD Checklist - Military Version | 12-month Post-deployment | 24.3 units on a scale | Standard Deviation 8.6 |
| Control | The PTSD Checklist - Military Version | Pre-deployment | 23.8 units on a scale | Standard Deviation 9.6 |
| Control | The PTSD Checklist - Military Version | 12-month Post-deployment | 23.9 units on a scale | Standard Deviation 9.7 |
| Control | The PTSD Checklist - Military Version | 3-months Post-deployment | 28.5 units on a scale | Standard Deviation 12.7 |
Secondary
Patient Health Questionnaire (PHQ-9)
The 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.
Time frame: pre-deployment, 3-, and 12-month post-deployment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HRV Biofeedback | Patient Health Questionnaire (PHQ-9) | 2.83 units on a scale | Standard Deviation 3.19 |
| Cognitive Bias Modification Training | Patient Health Questionnaire (PHQ-9) | 3.02 units on a scale | Standard Deviation 3.27 |
| Control | Patient Health Questionnaire (PHQ-9) | 3.03 units on a scale | Standard Deviation 3.29 |