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Completed

NCT Number: NCT02736929

The Effect of Reducing Posttraumatic Stress Disorder Symptoms on Cardiovascular Risk

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.

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Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27706, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Is between the ages of 40 and 65;
  • Has current PTSD lasting at least three months, based on the Clinician Administered PTSD Scale (CAPS), DSM 5 version, with a CAPS total 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 as indicated by scores less than 20 on the Montreal Cognitive Assessment (MoCA);
  • 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 a urine drug screen positive for cocaine and/or methamphetamine and reports regular use of that substance;
  • Has severely impaired hearing or speech;
  • Is pregnant;
  • Has established heart disease, abnormal heart rhythm, advanced cancer, or epilepsy
  • Has HIV positive status with unstable disease status and/or unstable medication use;
  • 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 inflammatory condition such as infection, fever, 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.

Treatment and study plan

Cognitive Processing Therapy - Cognitive

Behavioral

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 names: CPT-C

Primary outcomes

  1. Change From Baseline to Post-Intervention in 24-hour Heart Rate Variability (HRV) Estimated From the Standard Deviation of the Interbeat Interval of Normal Sinus Beats (SDNN)

    Time frame: Baseline & post-intervention (up to 20 weeks)

    24-hour HRV measured from SDNN was obtained from 24-hours of ambulatory electocardiograph (ECG) recordings. Inclusion criteria for HRV requires that at least 80% of the recording show normal sinus rhythm. SDNN is an independent predictor of coronary heart disease and cardiac death. Means for SDNN are listed below, and evaluation of change in scores can be found in statistical analysis 1.

Secondary outcomes

  1. Change From Baseline to Post-Intervention in 24-hour Heart Rate Variability (HRV) Estimated From Low Frequency HRV (LF-HRV)

    Time frame: Baseline & post-intervention (up to 20 weeks)

    24-hour HRV measured from LF-HRV was obtained from 24-hours of ambulatory electrocardiograph (ECG) recordings. Inclusion criteria for HRV requires that at least 80% of the recording show normal sinus rhythm. LF-HRV is a frequency domain measure of HRV which captures all heart rate variations occurring over the frequency band linked to sympathetic vasomotor oscillations. Higher LF-HRV reflects stronger baroreflex cardiovascular control which is offset by increases in cardiac efferent sympathetic activity during periods of acute stress and physical activity. Low levels of LF-HRV are predictive of incident diabetes and increased coronary heart disease risk. Means for LF-HRV are listed below, and evaluation of change in scores can be found in statistical analysis 1.

  2. Change in Heart Rate Variability (HRV) Measured by Holter Monitor, as Indicated by High Frequency HRV (HF-HRV)

    Time frame: Baseline & post-intervention (up to 20 weeks)

    24-hour HRV measured from HF-HRV was obtained from 24-hours of ambulatory electocardiograph (ECG) recordings. Inclusion criteria for HRV requires that at least 80% of the recording show normal sinus rhythm. HF-HRV is a frequency domain measure of HRV which captures all heart rate variations occurring over the frequency band linked to respiration. Higher HF-HRV reflects stronger parasympathetic cardiac control. Low levels of HF-HRV are predictive of increased coronary heart disease risk. Means for HF-HRV are listed below, and evaluation of change in scores can be found in statistical analysis 1.

  3. Change in Heart Rate Variability (HRV) as Measured by Root Square Mean of Successive Interbeat Interval Differences (RMSSD)

    Time frame: Baseline & post-intervention (up to 20 weeks)

    24-hour HRV measured from RMSSD was obtained from 24-hours of ambulatory electocardiograph (ECG) recordings. Inclusion criteria for HRV requires that at least 80% of the recording show normal sinus rhythm. RMSSD is a time domain measure of HRV which captures heart rate variations occurring over the frequency band linked to respiration. Higher RMSSD reflects stronger parasympathetic cardiac control. Means for RMSSD are listed below, and evaluation of change in scores can be found in statistical analysis 1.

  4. Change From Baseline to Post-Intervention in 24-hour Urinary Excretion of Norepinephrine

    Time frame: Baseline & post-intervention (up to 20 weeks)

    24-hour urinary excretion of norepinephrine was obtained from 24-hours of urine collection. Inclusion criteria for 24-hour urine collection requires that at least 300 milliliters of urine be collected. Norepinephrine levels have been found to be elevated in PTSD and following trauma exposure. Norepinephrine is implicated in the association between cardiovascular disease and stress. Means for norepinephrine are listed below, and evaluation of change in scores can be found in statistical analysis 1.

  5. Change From Baseline to Post-Intervention in 24-hour Urinary Excretion of Epinephrine

    Time frame: Baseline & post-intervention (up to 20 weeks)

    24-hour urinary excretion of epinephrine was obtained from 24-hours of urine collection. Inclusion criteria for 24-hour urine collection requires that at least 300 milliliters of urine be collected. Epinephrine levels have been found to be elevated in PTSD and following trauma exposure. Epinephrine is implicated in the association between cardiovascular disease and stress. Means for epinephrine are listed below, and evaluation of change in scores can be found in statistical analysis 1.

  6. Change From Baseline to Post-Intervention in High Sensitivity C-Reactive Protein (Hs-CRP)

    Time frame: Baseline & post-intervention (up to 20 weeks)

    Peripheral inflammation was measured from fasting levels of CRP. Inclusion criteria for measurement of hsCRP requires that the participant be free from active infections or acute inflammatory conditions; therefore, participants were required to be free of fever, infections, and acute inflammatory conditions for a minimum of 7 days prior to the blood draw. Oral temperatures were obtained from all participants to check for sickness at the time of blood draw. CRP will be measured because it has a strong correlation with cardiovascular morbidity and mortality. Means for hs-CRP are listed below, and evaluation of change in scores can be found in statistical analysis 1.

  7. Change From Baseline to Post-Intervention in Flow-Mediated Dilation (FMD)

    Time frame: Baseline & post-intervention (up to 20 weeks)

    Vascular endothelial function was measured under fasting conditions from the percent change in dilation of the brachial artery following controlled occlusion of the artery. FMD is a measure of health of blood vessels. Lower flow mediated dilation is associated with poor cardiovascular health. FMD was measured because it has been correlated with cardiovascular morbidity and mortality and is reduced following trauma exposure. Means for FMD are listed below, and evaluation of change in scores can be found in statistical analysis 1.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: ACCEPT

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Apr 13, 2016
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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