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The Effect of Reducing Posttraumatic Stress Disorder Symptoms on Cardiovascular Risk (ACCEPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02736929
Recruitment Status : Recruiting
First Posted : April 13, 2016
Last Update Posted : March 20, 2019
Information provided by (Responsible Party):
Duke University

Brief Summary:
Some individuals who are exposed to traumatic events experience both psychological and cardiovascular changes that affect their health and well-being. The purpose of this study is to learn more about how reducing the psychological symptoms (such as those that occur with posttraumatic stress disorder, or PTSD) affects cardiovascular systems that regulate heart and blood pressure.

Condition or disease Intervention/treatment Phase
PTSD Behavioral: Cognitive Processing Therapy - Cognitive Not Applicable

Detailed Description:
There is a fundamental gap in the understanding of how a diagnosis of post-traumatic stress disorder (PTSD) portends excess risk of coronary heart disease (CHD). This is primarily because of two reasons: (1) the core studies which provide support for an association between PTSD and CHD risk depended on lengthy follow-up periods with no repeat measurement of either PTSD or other related cardiovascular risk factors; (2) PTSD is highly comorbid with both adverse health behaviors and with psychiatric comorbidity that also vary across time and could largely explain the association between PTSD and increased risk of CHD. The long-term goal is to better understand whether there is a direct link between PTSD and CHD risk, as well as to ascertain the role of candidate pathophysiological mechanisms. The study proposed in this application is designed to examine how changes in PTSD symptoms following an established therapeutic intervention (Cognitive Processing Therapy) affect CHD disease pathways in individuals with PTSD. This design will permit an evaluation of the hypothesis that individuals who show significant improvement in PTSD symptoms will also show improvement in CHD risk biomarkers, and individuals who fail to show improvement or show worsening PTSD symptoms, will show no change or worsening in CHD biomarker activity. The study will also provide an evaluation of the role of key stress-related CHD biomarkers as mechanisms underlying the increased CHD risk burden associated with PTSD. Choice of CHD biomarkers focused on the established association of PTSD with chronic activation of stress response systems and includes autonomic nervous system dysregulation, chronic systemic inflammation, and vascular endothelial dysfunction. The proposed research is significant because it is expected to provide knowledge of the role of both the direct impact of PTSD symptoms on CHD risk pathways and the role of these systems as candidate mechanisms underlying the relationship between PTSD and CHD risk. By better defining how PTSD is a risk factor for CHD, as well as identifying the disease pathways involved, the proposed study will help inform strategies for CHD prevention, as well as guide optimal medical management for vulnerable men and women with PTSD, especially in those who refrain or who are refractory to psychiatric treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of Reducing Posttraumatic Stress Disorder Symptoms on Cardiovascular Risk
Study Start Date : April 2016
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Cognitive Processing Therapy - Cognitive
Cognitive Processing Therapy - Cognitive (CPT-C), is a brief cognitive behavioral treatment for PTSD. CPT-C consists of 2 hours of therapy each week for 6 weeks (i.e., two sessions).
Behavioral: Cognitive Processing Therapy - Cognitive
CPT-C is a brief cognitive behavioral treatment for PTSD. It consists of 2 hours of therapy each week for 6 weeks (i.e., two sessions).
Other Name: CPT-C

No Intervention: Waiting Period Control (WP-CON)
WP-CON group will receive minimal attention in the form of weekly telephone calls to assess current emotional state and to provide supportive, nondirective, brief counseling if participants report experiencing a crisis. Any participant assigned to the WP-CON group will be given the opportunity to receive CPT-C after the post-waiting period assessment.

Primary Outcome Measures :
  1. Change in heart rate variability (HRV) [ Time Frame: Baseline & post-treatment (or wait period, approximately 6 weeks) ]
    24-hour heart rate variability (HRV) is measured by Holter monitor. HRV is a strong independent predictor of coronary heart disease and cardiac death.

Secondary Outcome Measures :
  1. Change in 24-hour urinary catecholamine [ Time Frame: Baseline & post-treatment (or wait period, approximately 6 weeks) ]
    Participants will collect urine for a 24-hour period at baseline and at post-treatment or wait period (approximately six weeks). 24-hour urinary catecholamine excretion has been consistently found to be elevated in PTSD and also is predictive of increased risk of mortality.

  2. Change in inflammatory activity, measured by high sensitivity C-reactive protein (hs-CRP) [ Time Frame: Baseline & post-treatment (or wait period, approximately 6 weeks) ]
    Peripheral inflammation will be measured because it has a strong correlation with cardiovascular morbidity and mortality.

  3. Change in vascular endothelial function, measured by brachial artery flow mediated dilation (FMD) [ Time Frame: Baseline & post-treatment (or wait period, approximately 6 weeks) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Has current PTSD lasting at least three months with a Clinician-Administered PTSD Scale score of 25 or greater; and
  • Will have been stable on any current psychiatric medications for four weeks prior to the Time 1 assessment.

Exclusion Criteria:

  • Is currently participating in evidence-based trauma focused therapy (e.g., CPT, prolonged exposure) for PTSD (current or past 6 months);
  • Has current dementia or other memory loss condition, as indicated by self report or a score less than 20 on the Montreal Cognitive Assessment;
  • Has current psychotic spectrum disorder or bipolar disorder;
  • Has current uncontrolled substance use disorder that would interfere with his/her ability to perform study procedures;
  • Has severely impaired hearing or speech;
  • Is pregnant;
  • Has established heart disease, abnormal heart rhythm, cancer, or epilepsy;
  • Has current exposure to ongoing trauma (e.g., physically abusive relationship);
  • Has prominent suicidal or homicidal ideation (as assessed through a clinical interview);
  • Has a serious/terminal illness or other health problem that would prohibit participation in the study;
  • Has an acute inflammatory condition such as infection, fever, or a one-month history of accident or surgery, rheumatoid arthritis, lupus, or inflammatory bowel disease;
  • Is unwilling to accept randomization; or
  • Cannot agree to attend therapy sessions at least once per week.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02736929

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Contact: Tifffany Beaver, M.S. 919-668-6040

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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27706
Contact: Angela C Kirby, MS    919-286-0411 ext 5526      
Sponsors and Collaborators
Duke University
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Principal Investigator: Lana Watkins, Ph.D. Duke University
Principal Investigator: Jean C. Beckham, Ph.D. Duke University

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Responsible Party: Duke University Identifier: NCT02736929     History of Changes
Other Study ID Numbers: Pro00067912
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders