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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breathing training | Experimental | relaxation training |
|
| Treatment as usual | No Intervention | treatment as usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breathing training | Behavioral | relaxation training |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and 8 weeks |
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Inclusion Criteria:
*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*
This will be defined as having a CAPS frequency plus intensity ratings greater than or equal to 4.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walton Roth, MD | VA Palo Alto Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System | Palo Alto | California | 94304-1290 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31804108 | Derived | 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. | |
| 29171107 | Derived | Slightam 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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| ID | Title | Description |
|---|---|---|
| FG000 | Breathing Training | relaxation training |
| FG001 | Treatment as Usual | No intervention - treatment as usual |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Breathing Training | relaxation training |
| BG001 | Treatment as Usual | No intervention: Treatment as usual |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Breathing Training | relaxation training |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Musculoskeletal and connective tissue disorders | Unplanned knee surgery |
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Higher than anticipated withdrawal rate limited power of statistical analyses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Walton T. Roth, M.D. | VA Palo Alto Health Care System / Stanford University School of Medicine | 650-493-5000 | 65243 | wtroth@stanford.edu |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001945 | Breathing Exercises |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
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| Death |
|
| Became ineligible |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
No intervention: treatment as usual |
|
|
|
| 3 |
| 47 |
| 0 |
| 47 |
| EG001 | Treatment as Usual | No intervention: Treatment as usual | 1 | 33 | 0 | 33 |
| Death | Blood and lymphatic system disorders | Multiple myeloma |
|
| Hospitalization | Psychiatric disorders | Alcohol and drug relapse |
|
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| D026741 |
| Physical Therapy Modalities |