Post Traumatic Stress Disorder (PTSD) Hyperarousal Symptoms Treated With Physiological Stress Management

Stress Disorders, Post-Traumatic Clinical Trial

— BaRT  

Official title:

PTSD Hyperarousal Symptoms Treated With Physiological Stress Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00855816
• Other study ID #: MHBA-019-08F
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 3, 2009
• Last updated: October 14, 2014
• Start date: February 2010
• Est. completion date: July 2013

Study information

• Verified date: October 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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*

• 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 and will not be accepted until these problems are resolved.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Breathing training
relaxation training

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Baseline and 8 weeks	No