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

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Breathing training
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stress Disorders, Post-Traumatic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • VA Palo Alto Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Breathing training

Treatment as usual

Arm Description

relaxation training

treatment as usual

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
March 3, 2009
Last Updated
October 14, 2014
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00855816
Brief Title
Post Traumatic Stress Disorder (PTSD) Hyperarousal Symptoms Treated With Physiological Stress Management
Acronym
BaRT
Official Title
PTSD Hyperarousal Symptoms Treated With Physiological Stress Management
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breathing training
Arm Type
Experimental
Arm Description
relaxation training
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Breathing training
Intervention Description
relaxation training
Primary Outcome Measure Information:
Title
Change Scores for Criteria D Items on the CAPS Structured Clinical Interview
Description
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).
Time Frame
Baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walton Roth, MD
Organizational Affiliation
VA Palo Alto Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31804108
Citation
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.
Results Reference
derived
PubMed Identifier
29171107
Citation
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.
Results Reference
derived

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

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