Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00365196
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2006-08-16
Brief Title:
Hostility Reduction Program to Improve Autonomic Regulation of the Heart
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
Hostility Reduction and Autonomic Control of the Heart
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Individuals who experience high hostility levels may be more prone to developing coronary artery disease CAD than individuals who experience low hostility levels This study will evaluate the effectiveness of a hostility reduction treatment program on the bodys ability to regulate heart activity in individuals with high levels of hostility
Detailed Description:
CAD is caused by a narrowing of the blood vessels that supply blood and oxygen to the heart It is the leading cause of death in the United States Recent evidence has suggested that individuals with increased hostility levels have a higher risk of developing CAD than individuals with lower hostility levels The autonomic nervous system ANS the involuntary part of the nervous system that is responsible for controlling the bodys internal environment in a coordinated manner may play a role in CAD development High levels of hostility may elevate ANS activity and increase the release of certain hormones which in turn may lead to hardening of the arteries and CAD Cognitive behavioral therapy CBT has been effective for treating individuals with hostility Through CBT individuals develop coping skills to deal with their anger This study will evaluate the effect of a CBT hostility reduction treatment program on ANS heart regulation and overall CAD risk in individuals with high levels of hostility
This study will enroll individuals with high levels of hostility At an initial screening visit potential participants will partake in interviews and complete questionnaires to assess hostility levels Eligible participants will then undergo 24-hour continuous electrocardiogram ECG monitoring and will complete questionnaires about their surroundings and any hostility experienced during the 24-hour period They will also undergo psychophysiological testing in which responses to a variety of stress-inducing situations will be monitored Participants will then be randomly assigned to either a 12-week CBT hostility reduction treatment program or a 12-week wait list control group Participants in the CBT program will attend weekly 75-minute therapy sessions which will focus on relaxation stress reduction behavior management and development of social communication and coping skills Hostility levels will be documented each day in a diary Participants in the wait list control group will not take part in any therapy sessions for the initial 12 weeks At Week 12 baseline evaluations will be repeated for all participants The waitlist control group will then begin the 12-week CBT program All participants will attend a 6-month follow-up visit for repeat testing
This study will enroll individuals with high levels of hostility At an initial screening visit potential participants will partake in interviews and complete questionnaires to assess hostility levels Eligible participants will then undergo 24-hour continuous electrocardiogram ECG monitoring and will complete questionnaires about their surroundings and any hostility experienced during the 24-hour period They will also undergo psychophysiological testing in which responses to a variety of stress-inducing situations will be monitored Participants will then be randomly assigned to either a 12-week CBT hostility reduction treatment program or a 12-week wait list control group Participants in the CBT program will attend weekly 75-minute therapy sessions which will focus on relaxation stress reduction behavior management and development of social communication and coping skills Hostility levels will be documented each day in a diary Participants in the wait list control group will not take part in any therapy sessions for the initial 12 weeks At Week 12 baseline evaluations will be repeated for all participants The waitlist control group will then begin the 12-week CBT program All participants will attend a 6-month follow-up visit for repeat testing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL063872-04 | NIH | None | httpsreporternihgovquickSearchR01HL063872-04 |