The Effect of Reducing Posttraumatic Stress Disorder Symptoms on Cardiovascular Risk



Status:Recruiting
Conditions:Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:40 - 65
Updated:3/22/2019
Start Date:April 2016
End Date:February 2021
Contact:Tifffany Beaver, M.S.
Email:tiffanyannaba.beaver@duke.edu
Phone:919-668-6040

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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.

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.

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.
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-286-0411
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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from
Durham, NC
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