Coronary Arteriosclerosis Clinical Trial
Official title:
Hostility Reduction and Autonomic Control of the Heart
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Treatment
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