N/A
N=112
The Effect of Reducing Posttraumatic Stress Disorder Symptoms on Cardiovascular Risk
PTSD
Bottom Line
View on ClinicalTrials.gov: NCT02736929 ↗Enrolled (actual)
112
Serious AEs
0.7%
Results posted
Apr 2024
Primary outcome: Primary: 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) — 118; 113; 123; 108 milliseconds — p=0.12
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Processing Therapy - Cognitive (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
118; 113; 123; 108 | 0.12 |
| SECONDARY Change From Baseline to Post-Intervention in 24-hour Heart Rate Variability (HRV) Estimated From Low Frequency HRV (LF-HRV) |
5.9; 5.9; 5.9; 5.7 | 0.024 sig |
| SECONDARY Change in Heart Rate Variability (HRV) Measured by Holter Monitor, as Indicated by High Frequency HRV (HF-HRV) |
4.9; 5.0; 5.0; 4.8 | 0.027 sig |
| SECONDARY Change in Heart Rate Variability (HRV) as Measured by Root Square Mean of Successive Interbeat Interval Differences (RMSSD) |
23.3; 24.7; 24.3; 22.1 | 0.024 sig |
| SECONDARY Change From Baseline to Post-Intervention in 24-hour Urinary Excretion of Norepinephrine |
36.3; 39.8; 33.6; 38.6 | 0.19 |
| SECONDARY Change From Baseline to Post-Intervention in 24-hour Urinary Excretion of Epinephrine |
4.4; 5.0; 3.3; 3.9 | 0.31 |
| SECONDARY Change From Baseline to Post-Intervention in High Sensitivity C-Reactive Protein (Hs-CRP) |
4.0; 3.6; 3.9; 3.9 | 0.86 |
| SECONDARY Change From Baseline to Post-Intervention in Flow-Mediated Dilation (FMD) |
2.5; 3.6; 3.4; 3.7 | 0.77 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02736929). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.