| City: |
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Palo Alto |
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State:
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CA |
| Zip Code: |
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94304 |
| Conditions: |
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Stress Disorders, Post-Traumatic |
| Purpose: |
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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.
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| Study summary: |
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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. 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. |
| Criteria: |
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with evidence of current significant alcohol abuse or dependence, psychosis,
or substantial cognitive deficits, or who are severely depressed or acutely suicidal
will not be accepted until these problems are resolved. |
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| Study is available at: |
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VA Palo Alto Health Care System
Palo Alto, CA 94304
United States
Primary Contact:
Walton Roth, MD
Email: wtroth@stanford.edu
Phone: 650-493-5000
Secondary Contact:
Walton Roth, MD
Email: wtroth@stanford.edu
Phone: (650) 493-5000 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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above to view all information about this clinical trial. |
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