HostilityNCT00365196
Hostility Reduction Program to Improve Autonomic Regulation of the Heart
A study testing CBT Hostility Reduction Program in people with Hostility and Coronary Arteriosclerosis, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hostility, Coronary Arteriosclerosis
- What is being tested?
- CBT Hostility Reduction Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Dec 1999to Jan 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Psychiatric disorder
- Currently taking psychiatric medications
- Currently taking cardioactive medications
- Medical condition that affects the ANS
- Currently taking medications that affect the cardiovascular system
About this study
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.
Read the 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.
- Conditions
- Hostility, Coronary Arteriosclerosis
- Being tested
- CBT Hostility Reduction Program
- Keywords
- Autonomic Nervous System
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT Hostility Reduction ProgramBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac autonomic regulation (measured at Week 12 and at 6-month follow-up evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2006 (estimated)
- Study startDec 1999
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HostilityStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 150 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Richard P. Sloan, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365196
- Sponsor's protocol ID
- 399
- Other IDs
- R01HL063872-04
- Status last verified
- Dec 2007
- First submitted
- 16 Aug 2006
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
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.
PubMed 21257979
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hostility Reduction and Autonomic Control of the Heart
- ClinicalTrials.gov ID
- NCT00365196
- Acronym / sponsor ID
- 399
- Conditions
- Hostility, Coronary Arteriosclerosis
- Keywords
- Autonomic Nervous System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Dec 1999
- Study completion
- Jan 2006 (actual)
- First posted
- 17 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Psychiatric disorder
- Currently taking psychiatric medications
- Currently taking cardioactive medications
- Medical condition that affects the ANS
- Currently taking medications that affect the cardiovascular system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT Hostility Reduction Program | Behavioural | – |
Primary outcome
Cardiac autonomic regulation (measured at Week 12 and at 6-month follow-up evaluation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Derived from this study: PubMed 21257979Sloan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard P. Sloan, PhD principal investigator
Columbia University
Questions about this trial
What is this clinical trial studying?
A study testing CBT Hostility Reduction Program in people with Hostility and Coronary Arteriosclerosis, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac autonomic regulation (measured at Week 12 and at 6-month follow-up evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00365196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.