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

April 16, 2024 updated by: Duke University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27706
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline & post-intervention (up to 20 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline & post-intervention (up to 20 weeks)
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.
Baseline & post-intervention (up to 20 weeks)
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.
Baseline & post-intervention (up to 20 weeks)
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.
Baseline & post-intervention (up to 20 weeks)
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.
Baseline & post-intervention (up to 20 weeks)
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.
Baseline & post-intervention (up to 20 weeks)
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.
Baseline & post-intervention (up to 20 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lana Watkins, Ph.D., Duke University
  • Principal Investigator: Jean C. Beckham, Ph.D., Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00067912

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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