Post Traumatic Stress DisorderNCT01571245
Predicting Treatment Response Using Psychophysiologic Reactivity Measures
An observational study of Post Traumatic Stress Disorder, run by Central Arkansas Veterans Healthcare System at 1 site in United States.
Trial summary
Objective psychophysiologic reactivity data may be useful for predicting post-traumatic stress disorder (PTSD) treatment response. Given the variety of PTSD treatments and the lack of a clearly superior treatment, a reliable and valid approach to predicting treatment response is needed. Specific Aims: 1). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult
Study population: Veterans receiving or seeking treatment at the Central Arkansas Veterans Healthcare Administration Mental Health Clinics.
Who may be able to join
- OEF/OIF/OND Veterans
- Ages 18 to 60 (The investigators chose to limit the recruitment age to 60 because heart rate variability decreases dramatically with age and therefore may not demonstrate the variability necessary for use in a prediction model.)
- Currently in or about to start treatment for deployment-related PTSD at Mental Health Clinics
- PTSD symptom severity score using the PTSD Checklist-Civilian version of 40 or greater
- Able to provide the name and phone number of at least one contact person in case of difficulty locating participant for the follow-up assessment.
Who cannot join
- Current diagnosis of schizophrenia
- Daily use of benzodiazepines except as needed for sleep,
- Daily use of beta-blockers
- Plans to leave the area within 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
CAVHS Eugene Towbin VA Medical Center
North Little Rock, Arkansas, 72114-1706
About this study
Objective psychophysiologic reactivity data may be useful for predicting post-traumatic stress disorder (PTSD) treatment response. Given the variety of PTSD treatments and the lack of a clearly superior treatment, a reliable and valid approach to predicting treatment response is needed.
Specific Aims: 1). Evaluate the clinical utility of psychophysiologic reactivity measures to predict overall PTSD symptom response among OEF/OIF/OND (Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn) veterans receiving treatment for PTSD. 2). Evaluate the clinical utility of psychophysiologic reactivity measures to predict psychosocial functioning and health-related quality of life (HRQoL) response among OEF/OIF/OND veterans in treatment for PTSD. Exploratory). Develop psychophysiologic, neuropsychological, and/or self-report models to predict PTSD symptom response to pharmacotherapy, psychotherapy, and combined pharmacotherapy/psychotherapy. The investigators will divide psychophysiologic reactivity predictors into two groups: heart rate variability and attentional bias (eye gaze tracking and modified Stroop). The investigators will collect observational and longitudinal data from a treatment-seeking sample of 50 OEF/OIF/OND veterans with PTSD recruited from the Central Arkansas Veterans Healthcare System (CAVHS) Mental Health Clinics.
Read the detailed description
All subjects will complete a baseline assessment including self-report data and psychophysiologic reactivity measures. Trained research assistants will collect psychophysiologic reactivity data. The investigators will collect the 3-month data in-person. At 6-months, self-report data will be collected in-person. If study participant is unable to complete the 6-month assessment in person the investigators will attempt to collect the self-report data by phone. The study instruments have all been previously administered by telephone. The project coordinator will schedule and track the participants using the telephone. The project coordinator will call participants to remind them about follow-up appointments. The consent form will also include the name and phone number of at least one contact person.
Psychophysiologic reactivity measures will be collected first to minimize fatigue. In addition, the psychophysiologic reactivity measures are context dependent and the investigators do not want the psychophysiologic measures to be primed by symptom reporting. Heart rate variability data will be collected at baseline for five minutes prior to other testing and then continued during eye gaze tracking and modified Stroop testing.
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Heart rate variability, Attentional Bias
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Veterans with PTSD | Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) veterans who are ages 18 to 60 and currently in or about to start treatment for deployment-related Post-Traumatic Stress Disorder (PTSD) at the Central Arkansas Veterans Healthcare System Mental Health Clinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Eye-gaze Tracking
This measures attentional bias.
Measured: from Baseline to 6 months
Secondary outcomes (2)
Change in Modified Stroop
This measures attentional bias
Measured: from Baseline to 6 months
Change in Heart rate variability
Measured: from Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Arkansas Veterans Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- John Spollen, MD, Principal investigator, Central Arkansas Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571245
- Sponsor's protocol ID
- 252121
- Other IDs
- PTRUPRM
- Status last verified
- Dec 2015
- First submitted
- 27 Mar 2012
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Treatment Response Using Psychophysiologic Reactivity Measures
- ClinicalTrials.gov ID
- NCT01571245
- Acronym / sponsor ID
- 252121
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Heart rate variability, Attentional Bias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Central Arkansas Veterans Healthcare SystemUS federal agency
- Study start
- Apr 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective psychophysiologic reactivity data may be useful for predicting post-traumatic stress disorder (PTSD) treatment response. Given the variety of PTSD treatments and the lack of a clearly superior treatment, a reliable and valid approach to predicting treatment response is needed.
Specific Aims: 1). Evaluate the clinical utility of psychophysiologic reactivity measures to predict overall PTSD symptom response among OEF/OIF/OND (Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn) veterans receiving treatment for PTSD. 2). Evaluate the clinical utility of psychophysiologic reactivity measures to predict psychosocial functioning and health-related quality of life (HRQoL) response among OEF/OIF/OND veterans in treatment for PTSD. Exploratory). Develop psychophysiologic, neuropsychological, and/or self-report models to predict PTSD symptom response to pharmacotherapy, psychotherapy, and combined pharmacotherapy/psychotherapy. The investigators will divide psychophysiologic reactivity predictors into two groups: heart rate variability and attentional bias (eye gaze tracking and modified Stroop). The investigators will collect observational and longitudinal data from a treatment-seeking sample of 50 OEF/OIF/OND veterans with PTSD recruited from the Central Arkansas Veterans Healthcare System (CAVHS) Mental Health Clinics.
Detailed description
All subjects will complete a baseline assessment including self-report data and psychophysiologic reactivity measures. Trained research assistants will collect psychophysiologic reactivity data. The investigators will collect the 3-month data in-person. At 6-months, self-report data will be collected in-person. If study participant is unable to complete the 6-month assessment in person the investigators will attempt to collect the self-report data by phone. The study instruments have all been previously administered by telephone. The project coordinator will schedule and track the participants using the telephone. The project coordinator will call participants to remind them about follow-up appointments. The consent form will also include the name and phone number of at least one contact person.
Psychophysiologic reactivity measures will be collected first to minimize fatigue. In addition, the psychophysiologic reactivity measures are context dependent and the investigators do not want the psychophysiologic measures to be primed by symptom reporting. Heart rate variability data will be collected at baseline for five minutes prior to other testing and then continued during eye gaze tracking and modified Stroop testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Veterans with PTSD | – | –Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) veterans who are ages 18 to 60 and currently in or about to start treatment for deployment-related Post-Traumatic Stress Disorder (PTSD) at the Central Arkansas Veterans Healthcare System Mental Health Clinics. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Veterans receiving or seeking treatment at the Central Arkansas Veterans Healthcare Administration Mental Health Clinics.
Key inclusion criteria (5 listed)
- OEF/OIF/OND Veterans
- Ages 18 to 60 (The investigators chose to limit the recruitment age to 60 because heart rate variability decreases dramatically with age and therefore may not demonstrate the variability necessary for use in a prediction model.)
- Currently in or about to start treatment for deployment-related PTSD at Mental Health Clinics
- PTSD symptom severity score using the PTSD Checklist-Civilian version of 40 or greater
- Able to provide the name and phone number of at least one contact person in case of difficulty locating participant for the follow-up assessment.
Key exclusion criteria (4 listed)
- Current diagnosis of schizophrenia
- Daily use of benzodiazepines except as needed for sleep,
- Daily use of beta-blockers
- Plans to leave the area within 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Eye-gaze Tracking
Time frame: from Baseline to 6 months
This measures attentional bias.
2 secondary outcomes
Change in Modified Stroop
Time frame: from Baseline to 6 months
Change in Heart rate variability
Time frame: from Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
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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.
John Spollen, 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?
An observational study of Post Traumatic Stress Disorder, run by Central Arkansas Veterans Healthcare System 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 5 inclusion and 4 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 15 Dec 2015. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Eye-gaze Tracking (time frame: from Baseline to 6 months). 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 15 Dec 2015.