Hostility Reduction Program to Improve Autonomic Regulation of the Heart

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00365196
Recruitment Status : Completed
First Posted : August 17, 2006
Last Update Posted : February 18, 2016
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

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.

Condition or disease Intervention/treatment Phase
Hostility Coronary Arteriosclerosis Behavioral: CBT Hostility Reduction Program Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Hostility Reduction and Autonomic Control of the Heart
Study Start Date : December 1999
Actual Study Completion Date : January 2006

Primary Outcome Measures :
  1. Cardiac autonomic regulation (measured at Week 12 and at 6-month follow-up evaluation)

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00365196

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Richard P. Sloan, PhD Columbia University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Richard P. Sloan, Columbia University Identifier: NCT00365196     History of Changes
Other Study ID Numbers: 399
R01HL063872-04 ( U.S. NIH Grant/Contract )
First Posted: August 17, 2006    Key Record Dates
Last Update Posted: February 18, 2016
Last Verified: December 2007

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Autonomic Nervous System

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases