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

NCT00855816 | Completed Phase 2 Results DMC

• 1 other identifier: MHBA-019-08F
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Breathing training

EXPERIMENTAL

relaxation training

Behavioral: Breathing training

Treatment as usual

NO INTERVENTION

treatment as usual

Interventions

Breathing training BEHAVIORAL

relaxation training

Breathing training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \*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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304-1290, United States

Location

Related Publications (2)

• 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.

  PMID: 31804108 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.

  PMID: 29171107 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Limitations and Caveats

Higher than anticipated withdrawal rate limited power of statistical analyses.

Results Point of Contact

• Title: Walton T. Roth, M.D.
• Organization: VA Palo Alto Health Care System / Stanford University School of Medicine

wtroth@stanford.edu

650-493-5000

Study Officials

• Walton Roth, MD

  VA Palo Alto Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2009
• First Posted: March 4, 2009
• Study Start: February 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 20, 2014
• Results First Posted: October 20, 2014

Record last verified: 2014-10

Locations

US (1)