Hostility Reduction Program to Improve Autonomic Regulation of the Heart
Primary Purpose
Hostility, Coronary Arteriosclerosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CBT Hostility Reduction Program
Sponsored by
About this trial
This is an interventional treatment trial for Hostility focused on measuring Autonomic Nervous System
Eligibility Criteria
Inclusion Criteria: In good general health Experiences a high level of hostility according to the Spielberger Trait Anger Scale and Cook Medley Scale (greater than 1 standard deviation for each scale) English speaking Exclusion Criteria: Psychiatric disorder Currently taking psychiatric medications Currently taking cardioactive medications Medical condition that affects the ANS Currently taking medications that affect the cardiovascular system
Sites / Locations
Outcomes
Primary Outcome Measures
Cardiac autonomic regulation (measured at Week 12 and at 6-month follow-up evaluation)
Secondary Outcome Measures
Full Information
NCT ID
NCT00365196
First Posted
August 16, 2006
Last Updated
February 17, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00365196
Brief Title
Hostility Reduction Program to Improve Autonomic Regulation of the Heart
Official Title
Hostility Reduction and Autonomic Control of the Heart
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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 body's 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 body's 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hostility, Coronary Arteriosclerosis
Keywords
Autonomic Nervous System
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
CBT Hostility Reduction Program
Primary Outcome Measure Information:
Title
Cardiac autonomic regulation (measured at Week 12 and at 6-month follow-up evaluation)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
In good general health
Experiences a high level of hostility according to the Spielberger Trait Anger Scale and Cook Medley Scale (greater than 1 standard deviation for each scale)
English speaking
Exclusion Criteria:
Psychiatric disorder
Currently taking psychiatric medications
Currently taking cardioactive medications
Medical condition that affects the ANS
Currently taking medications that affect the cardiovascular system
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard P. Sloan, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
21257979
Citation
Sloan RP, Shapiro PA, DeMeersman RE, Bagiella E, Brondolo EN, McKinley PS, Crowley O, Zhao Y, Schwartz JE, Myers MM. Impact of aerobic training on cardiovascular reactivity to and recovery from challenge. Psychosom Med. 2011 Feb-Mar;73(2):134-41. doi: 10.1097/PSY.0b013e31820a1174. Epub 2011 Jan 21.
Results Reference
derived
Learn more about this trial
Hostility Reduction Program to Improve Autonomic Regulation of the Heart
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