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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
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hostility focused on measuring Autonomic Nervous System

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 16, 2006
    Last Updated
    February 17, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    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

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    Hostility Reduction Program to Improve Autonomic Regulation of the Heart

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