Post Traumatic Stress Disorder (PTSD) Hyperarousal Symptoms Treated With Physiological Stress Management
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2/Phase 3

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 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.
    

Intervention name(s): Breathing training
Intervention type(s): Behavioral
Intervention description(s): relaxation training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic