The Effect of Reducing Posttraumatic Stress Disorder Symptoms on Cardiovascular Risk

NCT02736929 | Completed Results DMC

• 1 other identifier: Pro00067912
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD

Outcome Measures

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)

  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 Outcomes (7)

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

  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)

  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)

  Baseline & post-intervention (up to 20 weeks)

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

  Baseline & post-intervention (up to 20 weeks)

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

  Baseline & post-intervention (up to 20 weeks)

Study Arms (2)

Cognitive Processing Therapy - Cognitive

ACTIVE COMPARATOR

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

Waiting Period Control (WP-CON)

NO INTERVENTION

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.

Interventions

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).

Also known as: CPT-C

Cognitive Processing Therapy - Cognitive

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27706, United States

Location

Related Publications (1)

• LoSavio ST, Beckham JC, Wells SY, Resick PA, Sherwood A, Coffman CJ, Kirby AC, Beaver TA, Dennis MF, Watkins LL. The effect of reducing posttraumatic stress disorder symptoms on cardiovascular risk: Design and methodology of a randomized clinical trial. Contemp Clin Trials. 2021 Mar;102:106269. doi: 10.1016/j.cct.2021.106269. Epub 2021 Jan 8.

  PMID: 33429088 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Angela Kirby
• Organization: Duke University School of Medicine

angela.kirby@duke.edu

919-286-0411

Study Officials

• Lana Watkins, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

• Jean C. Beckham, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 13, 2016
• Study Start: April 1, 2016
• Primary Completion: July 20, 2021
• Study Completion: July 20, 2021
• Last Updated: April 17, 2024
• Results First Posted: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)