Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objectives of this proposal are to develop objective pre-deployment predictors of PTSD and test two pre-deployment resiliency interventions.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biofeedback training | Experimental | Heart rate variability biofeedback training and iPod with Breath Pacer app |
|
| Cognitive bias modification training | Experimental | Cognitive bias modification training and iPod with cognitive bias training app |
|
| Control Group | Sham Comparator | No additional resilience training and iPod with no resilience training apps |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| heart rate variability biofeedback | Device | Heart rate variability biofeedback, 3 session plus handheld device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | pre-deployment, 3-, and 12-months post-deployment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | pre-deployment, 3-, and 12-month post-deployment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey M Pyne, MD | Central Arkansas Veterans Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Army National Guard | Blackstone | Virginia | 23824 | United States |
426 soldiers were enrolled and completed the pre-deployment assessment. Fo these, 342 were randomized and had at least one follow-up assessment.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
342 participants completed at least one follow-up and were included in the analysis
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Bias Modification | Soldiers randomized to Cognitive Bias Modification for Interpretation training arm |
| BG001 | Heart Rate Variability Biofeedback | Soldiers randomized to Heart Rate Variability Biofeedback training arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | 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. | participants completed baseline and at least one follow-up | Posted | Mean | Standard Deviation | units on a scale | pre-deployment, 3-, and 12-months post-deployment |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HRV Biofeedback | Soldiers randomized to heart rate variability biofeedback training arm |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeff Pyne, MD | Central Arkansas Veterans Healthcare System | 501-257-1083 | jeffrey.pyne@va.gov |
Not provided
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cognitive bias modification training | Device | Cognitive bias modification training - 3 session plus handheld device |
|
| Sham Comparator | Device | Subjects received iPod without a study app and no additional resilience training |
|
| BG002 | Control | Soldiers randomly assigned to Control group |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Control | Soldiers randomized to the control arm |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | pre-deployment, 3-, and 12-month post-deployment |
|
|
|
| 0 |
| 102 |
| 0 |
| 102 |
| 0 |
| 102 |
| EG001 | Cognitive Bias Modification Training | Soldiers randomized to Cognitive Bias Modification for Interpretation training arm | 0 | 98 | 0 | 98 | 0 | 98 |
| EG002 | Control | Soldiers randomized to the control arm | 0 | 142 | 0 | 142 | 0 | 142 |
Not provided
Not provided