The Effect of Reducing Posttraumatic Stress Disorder Symptoms on Cardiovascular Risk (ACCEPT)
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|ClinicalTrials.gov Identifier: NCT02736929|
Recruitment Status : Recruiting
First Posted : April 13, 2016
Last Update Posted : March 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|PTSD||Behavioral: Cognitive Processing Therapy - Cognitive||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Reducing Posttraumatic Stress Disorder Symptoms on Cardiovascular Risk|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||February 2021|
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 Name: 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.
- Change in heart rate variability (HRV) [ Time Frame: Baseline & post-treatment (or wait period, approximately 6 weeks) ]24-hour heart rate variability (HRV) is measured by Holter monitor. HRV is a strong independent predictor of coronary heart disease and cardiac death.
- Change in 24-hour urinary catecholamine [ Time Frame: Baseline & post-treatment (or wait period, approximately 6 weeks) ]Participants will collect urine for a 24-hour period at baseline and at post-treatment or wait period (approximately six weeks). 24-hour urinary catecholamine excretion has been consistently found to be elevated in PTSD and also is predictive of increased risk of mortality.
- Change in inflammatory activity, measured by high sensitivity C-reactive protein (hs-CRP) [ Time Frame: Baseline & post-treatment (or wait period, approximately 6 weeks) ]Peripheral inflammation will be measured because it has a strong correlation with cardiovascular morbidity and mortality.
- Change in vascular endothelial function, measured by brachial artery flow mediated dilation (FMD) [ Time Frame: Baseline & post-treatment (or wait period, approximately 6 weeks) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736929
|Contact: Tifffany Beaver, M.S.||email@example.com|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27706|
|Contact: Angela C Kirby, MS 919-286-0411 ext 5526|
|Principal Investigator:||Lana Watkins, Ph.D.||Duke University|
|Principal Investigator:||Jean C. Beckham, Ph.D.||Duke University|