Post-traumatic Stress DisorderNCT00838006
Psychophysiologic Predictors of Post-deployment Mental Health Outcomes
A study testing heart rate variability biofeedback and Cognitive bias modification training in people with Post-traumatic Stress Disorder, run by Biomedical Research Foundation at 1 site in United States.
Trial summary
The primary objectives of this proposal are to develop objective pre-deployment predictors of PTSD and test two pre-deployment resiliency interventions. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- heart rate variability biofeedback and Cognitive bias modification training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 426 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Sep 2013
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Implantable pacemaker or cardiac defibrillator
- Unable to wear a virtual reality headset
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Army National Guard
Blackstone, Virginia, 23824
About this study
Official title: Identification of and At-Risk Interventions for Pre-deployment Psychophysiologic Predictors of Post-deployment Mental Health Outcomes
The primary objectives of this proposal are to develop objective pre-deployment predictors of PTSD and test two pre-deployment resiliency interventions.
Read the 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.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- heart rate variability biofeedback, Cognitive bias modification training, Sham Comparator
- Keywords
- post-traumatic stress disorder, post-deployment, prediction, prevention
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heart rate variability biofeedbackDevice
Heart rate variability biofeedback, 3 session plus handheld device
Cognitive bias modification trainingDevice
Cognitive bias modification training - 3 session plus handheld device
Sham ComparatorDevice
Subjects received iPod without a study app and no additional resilience training
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback training | Experimental | Heart rate variability biofeedback training and iPod with Breath Pacer app Receives: Device: heart rate variability biofeedback |
| Cognitive bias modification training | Experimental | Cognitive bias modification training and iPod with cognitive bias training app Receives: Device: Cognitive bias modification training |
| Control Group | Sham comparator | No additional resilience training and iPod with no resilience training apps Receives: Device: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-deployment, 3-, and 12-months post-deployment
Secondary outcomes (1)
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.
Measured: pre-deployment, 3-, and 12-month post-deployment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startSep 2008
- Primary completionSep 2013
- Study completionSep 2013
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 Post-traumatic Stress DisorderStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomedical Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Pyne, Biomedical Research Foundation
- Investigators
- Jeffrey M Pyne, MD, Principal investigator, Central Arkansas Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838006
- Sponsor's protocol ID
- PT074626
- Status last verified
- Jun 2020
- First submitted
- 4 Feb 2009
- Last updated
- 2 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of and At-Risk Interventions for Pre-deployment Psychophysiologic Predictors of Post-deployment Mental Health Outcomes
- ClinicalTrials.gov ID
- NCT00838006
- Acronym / sponsor ID
- PT074626
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- post-traumatic stress disorder, post-deployment, prediction, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Biomedical Research FoundationUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 6 Feb 2009 (estimated)
- Results
- Posted 2 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biofeedback training | Experimental | Device: heart rate variability biofeedbackHeart rate variability biofeedback training and iPod with Breath Pacer app |
| Cognitive bias modification training | Experimental | Device: Cognitive bias modification trainingCognitive bias modification training and iPod with cognitive bias training app |
| Control Group | Sham comparator | Device: Sham ComparatorNo additional resilience training and iPod with no resilience training apps |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Implantable pacemaker or cardiac defibrillator
- Unable to wear a virtual reality headset
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 |
|---|---|---|
| heart rate variability biofeedbackHeart rate variability biofeedback, 3 session plus handheld device | Device | Biofeedback training |
| Cognitive bias modification trainingCognitive bias modification training - 3 session plus handheld device | Device | Cognitive bias modification training |
| Sham ComparatorSubjects received iPod without a study app and no additional resilience training | Device | Control Group |
Primary outcome
The PTSD Checklist - Military Version
Time frame: 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.
1 secondary outcome
Patient Health Questionnaire (PHQ-9)
Time frame: pre-deployment, 3-, and 12-month post-deployment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeffrey M Pyne, MD principal investigator
Central Arkansas Veterans Healthcare 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 heart rate variability biofeedback and Cognitive bias modification training in people with Post-traumatic Stress Disorder, run by Biomedical Research Foundation 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 1 inclusion and 2 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 2 Jul 2020. 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 2 Jul 2020). 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?
The PTSD Checklist - Military Version (time frame: pre-deployment, 3-, and 12-months post-deployment). 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 2 Jul 2020.