Stress Disorders, Post-TraumaticPhase 2/3BaRTNCT00855816
Post Traumatic Stress Disorder (PTSD) Hyperarousal Symptoms Treated With Physiological Stress Management
A Phase 2/3 study testing Breathing training in people with Stress Disorders, Post-Traumatic, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Hyperarousal is a key symptom of PTSD. Even after receiving trauma-focused therapy, PTSD patients may continue to suffer from hyperarousal. Our main objectives are to measure hyperarousal in VA outpatients with PTSD related to combat experience in the last 10 years and to test the efficacy of physiological relaxation… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Breathing training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jul 2013
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants in the PTSD treatment MUST be US military veterans. Healthy volunteers may include members of the general community, as well as veterans or active duty military personnel
- Patients diagnosed by DSM-IV criteria for current PTSD,
- OR met DSM-IV criteria for PTSD within last 5 years.
- Patients must either have participated in a trauma-focused therapy,
- OR have declined to participate in such a therapy.
- In addition, they must currently score positive on at least 2 of the 5 D criteria symptoms.
- This will be defined as having a CAPS frequency plus intensity ratings greater than or equal to 4.
Who cannot join
- Patients with evidence of current significant alcohol abuse or dependence, psychosis, or substantial cognitive deficits,
- OR who are severely depressed or acutely suicidal and will not be accepted until these problems are resolved.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304-1290
About this study
Official title: PTSD Hyperarousal Symptoms Treated With Physiological Stress Management
Hyperarousal is a key symptom of PTSD. Even after receiving trauma-focused therapy, PTSD patients may continue to suffer from hyperarousal. Our main objectives are to measure hyperarousal in VA outpatients with PTSD related to combat experience in the last 10 years and to test the efficacy of physiological relaxation training in reducing this hyperarousal. Measurements will be both physiological, using 24 hour ambulatory monitoring of skin conductance, heart rate, and physical activity during waking and sleeping, and psychological, using self-reports and clinician interviews. Specific aims include initially evaluating 100 or more PTSD patients for the severity of their hyperarousal symptoms. Of these, 50 with at least moderate hyperarousal who either have participated in a trauma-focused therapy or have declined to participate in such a therapy will be recruited for a therapy trial. Volunteers will be randomized to treatment consisting of 5 sessions of individual physiological relaxation training with biofeedback over a 4-week period or to a 2-month waiting period after which they also may receive this therapy. Physiological evaluations of the patients' ability to relax will be measured at three times -before treatment, immediately after treatment, and 6 months after treatment. Clinical evaluations by interviews and questionnaires on measures of symptoms and disability will be measured at four times - before treatment, immediately after treatment, 1 month after treatment, and 6 months after treatment. The waiting-list group and a nonanxious control group will be tested psychophysiologically twice at the same interval as the patients before and immediately after treatment. A control group will allow us to calibrate our measures in the setting in which they are being applied. We hypothesize that this therapy will relieve both self-reported and objective, physiological symptoms of hyperarousal.
Relevance to health and the VA mission: Many of our clients at the VA Palo Alto Mental Health Outpatient Services for PTSD are veterans of Iraq, who need help with hyperarousal symptoms. This study will fill in gaps in our knowledge about the physiology of these symptoms and about the efficacy of relaxation therapies. Non-pharmacological treatments like the ones that we propose may relieve patients' hyperarousal to an extent that they are less tempted to turn to alcohol or sedative drugs.
Read the detailed description
Hyperarousal is a key symptom of PTSD. Even after receiving trauma-focused therapy, PTSD patients may continue to suffer from hyperarousal. Neuroimaging findings in PTSD support the idea that regulation of autonomic arousal from the cingulate cortex can be helpful in reducing anxiety.
Our main objectives are to measure hyperarousal in VA outpatients with PTSD related to combat experience in the last 10 years and to test the efficacy of physiological relaxation training in reducing this hyperarousal. Measurements will be both physiological, using 24 hour ambulatory monitoring of skin conductance, heart rate, and physical activity during waking and sleeping, and psychological, using self-reports and clinician interviews. Specific aims include initially evaluating 100 or more PTSD patients for the severity of their hyperarousal symptoms. Of these, 50 with at least moderate hyperarousal who either have participated in a trauma-focused therapy or have declined to participate in such a therapy will be recruited for a therapy trial. Volunteers will be randomized to treatment consisting of 5 sessions of individual physiological relaxation training with electromyographic feedback and with capnographic feedback over a 4-week period or to a 2-month waiting period after which they also may receive this therapy. Physiological evaluations of the patients' ability to relax while sitting quietly and their arousal levels during daily activities and sleep will be measured at three times -before treatment, immediately after treatment, and 6 months after treatment. Clinical evaluations by interviews and questionnaires on measures of symptoms and disability will be measured at four times - before treatment, immediately after treatment, 1 month after treatment, and 6 months after treatment. The waiting-list group and a nonanxious control group will be tested psychophysiologically twice at the same interval as the patients before and immediately after treatment. A control group will allow us to calibrate our measures in the setting in which they are being applied. We hypothesize that this therapy will relieve both self-reported and objective, physiological symptoms of hyperarousal.
Relevance to health and the VA mission: Many of our clients at the VA Palo Alto Mental Health Outpatient Services for PTSD are veterans of Iraq, who need help with hyperarousal symptoms. This study will fill in gaps in our knowledge about the physiology of these symptoms and about the efficacy of relaxation therapies. Non-pharmacological treatments like the ones that we propose may relieve patients' hyperarousal to an extent that they are less tempted to turn to alcohol or sedative drugs. Physiological proof of the effectiveness of relaxation procedures in this clinical group would help convince clinicians to apply them and patient consumers to try them.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Breathing training
- 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.
Breathing trainingBehavioural
relaxation training
| Study group | Role | What they receive |
|---|---|---|
| Breathing training | Experimental | relaxation training Receives: Behavioral: Breathing training |
| Treatment as usual | No intervention | treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Scores for Criteria D Items on the CAPS Structured Clinical Interview
Change in total score for all criterion D items on the Clinician-Administered PTSD Scale for DSM-IV, from baseline to post-treatment.
Total Criterion D subscore = sum of all frequency (0-4) and intensity (0-4) ratings of 5 PTSD hyperarousal symptoms.
Range: 0 to 40, with higher scores indicating more severe (frequent and/or intense) symptoms.
Change score calculated as: CAPS D score time 2 - CAPS D score time 1. Greater negative change scores indicate greater reduction in symptom severity (aka symptom improvement).
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startFeb 2010
- Primary completionJun 2013
- Study completionJul 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Walton Roth, MD, Principal investigator, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855816
- Sponsor's protocol ID
- MHBA-019-08F
- Acronym
- BaRT
- Status last verified
- Oct 2014
- First submitted
- 3 Mar 2009
- Last updated
- 20 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Jamison AL, Slightam C, Bertram F, Kim S, Roth WT. Randomized clinical trial of capnometry-assisted respiratory training in veterans with posttraumatic stress disorder hyperarousal. Psychol Trauma. 2022 Jul;14(5):883-893. doi: 10.1037/tra0000525. Epub 2019 Dec 5.
PubMed 31804108Slightam C, Petrowski K, Jamison AL, Keller M, Bertram F, Kim S, Roth WT. Assessing sleep quality using self-report and actigraphy in PTSD. J Sleep Res. 2018 Jun;27(3):e12632. doi: 10.1111/jsr.12632. Epub 2017 Nov 24.
PubMed 29171107
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PTSD Hyperarousal Symptoms Treated With Physiological Stress Management
- ClinicalTrials.gov ID
- NCT00855816
- Acronym / sponsor ID
- BaRT / MHBA-019-08F
- Conditions
- Stress Disorders, Post-Traumatic
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Feb 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 4 Mar 2009 (estimated)
- Results
- Posted 20 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hyperarousal is a key symptom of PTSD. Even after receiving trauma-focused therapy, PTSD patients may continue to suffer from hyperarousal. Our main objectives are to measure hyperarousal in VA outpatients with PTSD related to combat experience in the last 10 years and to test the efficacy of physiological relaxation training in reducing this hyperarousal. Measurements will be both physiological, using 24 hour ambulatory monitoring of skin conductance, heart rate, and physical activity during waking and sleeping, and psychological, using self-reports and clinician interviews. Specific aims include initially evaluating 100 or more PTSD patients for the severity of their hyperarousal symptoms. Of these, 50 with at least moderate hyperarousal who either have participated in a trauma-focused therapy or have declined to participate in such a therapy will be recruited for a therapy trial. Volunteers will be randomized to treatment consisting of 5 sessions of individual physiological relaxation training with biofeedback over a 4-week period or to a 2-month waiting period after which they also may receive this therapy. Physiological evaluations of the patients' ability to relax will be measured at three times -before treatment, immediately after treatment, and 6 months after treatment. Clinical evaluations by interviews and questionnaires on measures of symptoms and disability will be measured at four times - before treatment, immediately after treatment, 1 month after treatment, and 6 months after treatment. The waiting-list group and a nonanxious control group will be tested psychophysiologically twice at the same interval as the patients before and immediately after treatment. A control group will allow us to calibrate our measures in the setting in which they are being applied. We hypothesize that this therapy will relieve both self-reported and objective, physiological symptoms of hyperarousal.
Relevance to health and the VA mission: Many of our clients at the VA Palo Alto Mental Health Outpatient Services for PTSD are veterans of Iraq, who need help with hyperarousal symptoms. This study will fill in gaps in our knowledge about the physiology of these symptoms and about the efficacy of relaxation therapies. Non-pharmacological treatments like the ones that we propose may relieve patients' hyperarousal to an extent that they are less tempted to turn to alcohol or sedative drugs.
Detailed description
Hyperarousal is a key symptom of PTSD. Even after receiving trauma-focused therapy, PTSD patients may continue to suffer from hyperarousal. Neuroimaging findings in PTSD support the idea that regulation of autonomic arousal from the cingulate cortex can be helpful in reducing anxiety.
Our main objectives are to measure hyperarousal in VA outpatients with PTSD related to combat experience in the last 10 years and to test the efficacy of physiological relaxation training in reducing this hyperarousal. Measurements will be both physiological, using 24 hour ambulatory monitoring of skin conductance, heart rate, and physical activity during waking and sleeping, and psychological, using self-reports and clinician interviews. Specific aims include initially evaluating 100 or more PTSD patients for the severity of their hyperarousal symptoms. Of these, 50 with at least moderate hyperarousal who either have participated in a trauma-focused therapy or have declined to participate in such a therapy will be recruited for a therapy trial. Volunteers will be randomized to treatment consisting of 5 sessions of individual physiological relaxation training with electromyographic feedback and with capnographic feedback over a 4-week period or to a 2-month waiting period after which they also may receive this therapy. Physiological evaluations of the patients' ability to relax while sitting quietly and their arousal levels during daily activities and sleep will be measured at three times -before treatment, immediately after treatment, and 6 months after treatment. Clinical evaluations by interviews and questionnaires on measures of symptoms and disability will be measured at four times - before treatment, immediately after treatment, 1 month after treatment, and 6 months after treatment. The waiting-list group and a nonanxious control group will be tested psychophysiologically twice at the same interval as the patients before and immediately after treatment. A control group will allow us to calibrate our measures in the setting in which they are being applied. We hypothesize that this therapy will relieve both self-reported and objective, physiological symptoms of hyperarousal.
Relevance to health and the VA mission: Many of our clients at the VA Palo Alto Mental Health Outpatient Services for PTSD are veterans of Iraq, who need help with hyperarousal symptoms. This study will fill in gaps in our knowledge about the physiology of these symptoms and about the efficacy of relaxation therapies. Non-pharmacological treatments like the ones that we propose may relieve patients' hyperarousal to an extent that they are less tempted to turn to alcohol or sedative drugs. Physiological proof of the effectiveness of relaxation procedures in this clinical group would help convince clinicians to apply them and patient consumers to try them.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathing training | Experimental | Behavioral: Breathing trainingrelaxation training |
| Treatment as usual | No intervention | –treatment as usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants in the PTSD treatment MUST be US military veterans. Healthy volunteers may include members of the general community, as well as veterans or active duty military personnel
- Patients diagnosed by DSM-IV criteria for current PTSD,
- OR met DSM-IV criteria for PTSD within last 5 years.
- Patients must either have participated in a trauma-focused therapy,
- OR have declined to participate in such a therapy.
Key exclusion criteria (2 listed)
- Patients with evidence of current significant alcohol abuse or dependence, psychosis, or substantial cognitive deficits,
- OR who are severely depressed or acutely suicidal and will not be accepted until these problems are resolved.
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 |
|---|---|---|
| Breathing trainingrelaxation training | Behavioural | Breathing training |
Primary outcome
Change Scores for Criteria D Items on the CAPS Structured Clinical Interview
Time frame: Baseline and 8 weeks
Change in total score for all criterion D items on the Clinician-Administered PTSD Scale for DSM-IV, from baseline to post-treatment. Total Criterion D subscore = sum of all frequency (0-4) and intensity (0-4) ratings of 5 PTSD hyperarousal symptoms. Range: 0 to 40, with higher scores indicating more severe (frequent and/or intense) symptoms. Change score calculated as: CAPS D score time 2 - CAPS D score time 1. Greater negative change scores indicate greater reduction in symptom severity (aka symptom improvement).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31804108Jamison AL, Slightam C, Bertram F, Kim S, Roth WT. Randomized clinical trial of capnometry-assisted respiratory training in veterans with posttraumatic stress disorder hyperarousal. Psychol Trauma. 2022 Jul;14(5):883-893. doi: 10.1037/tra0000525. Epub 2019 Dec 5.
- Derived from this study: PubMed 29171107Slightam C, Petrowski K, Jamison AL, Keller M, Bertram F, Kim S, Roth WT. Assessing sleep quality using self-report and actigraphy in PTSD. J Sleep Res. 2018 Jun;27(3):e12632. doi: 10.1111/jsr.12632. Epub 2017 Nov 24.
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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.
Walton Roth, MD principal investigator
VA Palo Alto Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Breathing training in people with Stress Disorders, Post-Traumatic, run by US Department of Veterans Affairs 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 7 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 20 Oct 2014. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2014). 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?
Change Scores for Criteria D Items on the CAPS Structured Clinical Interview (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00855816, which also lists 2 linked publications.
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 20 Oct 2014; AzTrials last refreshed its copy on 1 Nov 2026.