Cardiovascular DiseasesNCT00005533
Hostility, Depression, Social Environment and CHD Risk
An observational study of Cardiovascular Diseases and Coronary Disease, run by Duke University.
Trial summary
To examine the separate and interactive effects of hostility, depressive symptomatology and socioeconomic status (SES) in predicting coronary heart disease risk. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- How many people
- 592 participants
- Where
- No sites listed yet
- Study dates
- Feb 1997to May 2009
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: coronary heart disease patients --- undergoing angiography
- Study One will use the data of the Danish National Cohort Study (DANCOS; Helwig-Larsen, et al., 2003)
- Study Two Part A will employ the same DANCOS sample that was used in Study One.
- Study Two Part B will use data from the Vietnam Experience Study (Center for Disease Control, 1988; Tegan, 2004)
- Study Three will be based on data from the patient sample previously collected under the investigator's former protocol (IRB #0608-04-5R5ER)
- Study Four will involve the follow-up of approximately 250 community volunteers who were intensively evaluated for hostility in laboratory sessions during the period of 1991-1993
About this study
To examine the separate and interactive effects of hostility, depressive symptomatology and socioeconomic status (SES) in predicting coronary heart disease risk.
Read the detailed description
BACKGROUND:
Hostility, depression/depressive personality, and socioeconomic status (SES) have all been shown to influence the risk of coronary heart disease (CHD). While the three factors have been studied separately in previous work, there is evidence that they are interrelated and there is reason to hypothesize that they would interact in a multiplicative fashion to dramatically increase risk when they are present in combination.
DESIGN NARRATIVE:
Three studies were conducted designed to describe the interrelationships of hostility, depression/depressive personality, and socioeconomic status and document their joint impact on several health outcomes. Study 1 took advantage of two existing databases to study over 3000 coronary artery disease patients who had been followed for over a decade. Both self-report and behavioral indicators of hostility and depression were studied in combination with SES to predict survival while controlling for initial disease severity. These measures were also used in analyses designed to discriminate the psychosocial profile of patients who died early in follow-up from those who died after five years. Data on health behavior profiles and medical care utilization were examined to evaluate the possibility that those factors could account for the relationships between psychosocial characteristics and survival.
Study 2 examined the ability of depressive personality, hostility, and SES to jointly predict acute myocardial infarction (AMI) and mortality in a sample of 730 initially healthy people who had been followed for 30 years. It also investigated the associations of these psychosocial measures with changes in risk factor patterns and health indicators over the follow-up period.
Study 3 administered a large battery of measures to community volunteers in order to document the interrelationships between hostility, depressive personality, and SES in detail. These measures were also used to predict the magnitude and duration of cardiovascular reactivity to mood induction tasks.
The study was renewed in FY 2000 to continue data analysis.
The study has been extended through June, 2009 to conduct four studies that address several questions. All will target significant clinical events such as coronary events and mortality as the primary dependent variables. Two of these are designed to test aspects of a model of mechanisms that account for the connections between stress and health outcomes. One of these is the notion that tangible, social, and psychological resources can moderate stress reactions. This leads to the hypothesis that good social relationships can be especially protective for those of low SES. This will be tested in a large representative population sample (Study One) and a large sample of military veterans. A corollary of this hypothesis is that the interaction of social support and SES should be most apparent in those under high levels of job strain, which will also be tested in the population sample. Both physical health and depressive symptoms will be the outcomes. Another resource is effective coping strategies for stress producing conditions. One of these may be tension reduction through moderate alcohol consumption, a proposition will be examined as an interaction between moderate alcohol usage and job strain in the same sample. Alcohol consumption is also hypothesized to affect health through other pathways in the conceptual model. The investigators have found that some psychosocial variables (hostility and depression) are associated with patterns of binge drinking and alcohol-related behavior problems, although this effect may be moderated by SES. This could account for some of the associations between hostility, depression, and health, a proposition that will be tested in the sample of veterans. The other studies will concentrate on the task of better illuminating the health effects due to particular components of two complex psychosocial variables that are often treated as more global constructs. One study of cardiac patients will rely on an extensive battery of depressive symptom measures collected during hospitalization to predict subsequent cardiac events and mortality. The other is a study of community volunteers who were assessed with a comprehensive set of hostility measures in the early 1990's. These will serve as predictors of subsequent cardiac events and mortality. All studies are expansions of past and current work, building on those findings to test new hypotheses, extend notions based previous findings to the prediction of significant clinical outcomes, and improve our conceptualizations of widely studied psychosocial risk factors.
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Depression
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Coronary Heart Disease Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Patients were interviewed at hospitalization for psychological status and are being followed for future health/later health.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startFeb 1997
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 592 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- John Barefoot, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005533
- Sponsor's protocol ID
- Pro00016441
- Other IDs
- 5R01HL054780, 5066
- Status last verified
- Feb 2013
- First submitted
- 25 May 2000
- Last updated
- 26 Oct 2023
- Results posted
- No
Publications
Brummett BH, Barefoot JC, Feaganes JR, Yen S, Bosworth HB, Williams RB, Siegler IC. Hostility in marital dyads: associations with depressive symptoms. J Behav Med. 2000 Feb;23(1):95-105. doi: 10.1023/a:1005424405056.
PubMed 10749013Brummett BH, Babyak MA, Barefoot JC, Bosworth HB, Clapp-Channing NE, Siegler IC, Williams RB Jr, Mark DB. Social support and hostility as predictors of depressive symptoms in cardiac patients one month after hospitalization: a prospective study. Psychosom Med. 1998 Nov-Dec;60(6):707-13. doi: 10.1097/00006842-199811000-00008.
PubMed 9847029Brummett BH, Maynard KE, Haney TL, Siegler IC, Barefoot JC. Reliability of interview-assessed hostility ratings across mode of assessment and time. J Pers Assess. 2000 Oct;75(2):225-36. doi: 10.1207/S15327752JPA7502_4.
PubMed 11020141Barefoot JC, Brummett BH, Clapp-Channing NE, Siegler IC, Vitaliano PP, Williams RB, Mark DB. Moderators of the effect of social support on depressive symptoms in cardiac patients. Am J Cardiol. 2000 Aug 15;86(4):438-42. doi: 10.1016/s0002-9149(00)00961-9.
PubMed 10946039Brummett BH, Barefoot JC, Siegler IC, Clapp-Channing NE, Lytle BL, Bosworth HB, Williams RB Jr, Mark DB. Characteristics of socially isolated patients with coronary artery disease who are at elevated risk for mortality. Psychosom Med. 2001 Mar-Apr;63(2):267-72. doi: 10.1097/00006842-200103000-00010.
PubMed 11292274Barefoot JC, Brummett BH, Helms MJ, Mark DB, Siegler IC, Williams RB. Depressive symptoms and survival of patients with coronary artery disease. Psychosom Med. 2000 Nov-Dec;62(6):790-5. doi: 10.1097/00006842-200011000-00008.
PubMed 11138998Barefoot JC, Mortensen EL, Helms MJ, Avlund K, Schroll M. A longitudinal study of gender differences in depressive symptoms from age 50 to 80. Psychol Aging. 2001 Jun;16(2):342-5. doi: 10.1037//0882-7974.16.2.342.
PubMed 11405320Barefoot JC, Gronbaek M, Feaganes JR, McPherson RS, Williams RB, Siegler IC. Alcoholic beverage preference, diet, and health habits in the UNC Alumni Heart Study. Am J Clin Nutr. 2002 Aug;76(2):466-72. doi: 10.1093/ajcn/76.2.466.
PubMed 12145024Brummett BH, Babyak MA, Mark DC, Williams RB, Siegler IC, Clapp-Channing N, Barefoot JC. Predictors of smoking cessation in patients with a diagnosis of coronary artery disease. J Cardiopulm Rehabil. 2002 May-Jun;22(3):143-7. doi: 10.1097/00008483-200205000-00003.
PubMed 12042680Surwit RS, Williams RB, Siegler IC, Lane JD, Helms M, Applegate KL, Zucker N, Feinglos MN, McCaskill CM, Barefoot JC. Hostility, race, and glucose metabolism in nondiabetic individuals. Diabetes Care. 2002 May;25(5):835-9. doi: 10.2337/diacare.25.5.835.
PubMed 11978677Fredrickson BL, Maynard KE, Helms MJ, Haney TL, Siegler IC, Barefoot JC. Hostility predicts magnitude and duration of blood pressure response to anger. J Behav Med. 2000 Jun;23(3):229-43. doi: 10.1023/a:1005596208324.
PubMed 10863676Williams RB, Barefoot JC, Schneiderman N. Psychosocial risk factors for cardiovascular disease: more than one culprit at work. JAMA. 2003 Oct 22;290(16):2190-2. doi: 10.1001/jama.290.16.2190. No abstract available.
PubMed 14570955Matthews KA, Gump BB, Harris KF, Haney TL, Barefoot JC. Hostile behaviors predict cardiovascular mortality among men enrolled in the Multiple Risk Factor Intervention Trial. Circulation. 2004 Jan 6;109(1):66-70. doi: 10.1161/01.CIR.0000105766.33142.13. Epub 2003 Dec 8.
PubMed 14662707Boyle SH, Williams RB, Mark DB, Brummett BH, Siegler IC, Barefoot JC. Hostility, age, and mortality in a sample of cardiac patients. Am J Cardiol. 2005 Jul 1;96(1):64-6. doi: 10.1016/j.amjcard.2005.02.046.
PubMed 15979435
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hostility, Depression, Social Environment and CHD Risk
- ClinicalTrials.gov ID
- NCT00005533
- Acronym / sponsor ID
- Pro00016441
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 592 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 1997
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 26 May 2000 (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.
To examine the separate and interactive effects of hostility, depressive symptomatology and socioeconomic status (SES) in predicting coronary heart disease risk.
Detailed description
BACKGROUND:
Hostility, depression/depressive personality, and socioeconomic status (SES) have all been shown to influence the risk of coronary heart disease (CHD). While the three factors have been studied separately in previous work, there is evidence that they are interrelated and there is reason to hypothesize that they would interact in a multiplicative fashion to dramatically increase risk when they are present in combination.
DESIGN NARRATIVE:
Three studies were conducted designed to describe the interrelationships of hostility, depression/depressive personality, and socioeconomic status and document their joint impact on several health outcomes. Study 1 took advantage of two existing databases to study over 3000 coronary artery disease patients who had been followed for over a decade. Both self-report and behavioral indicators of hostility and depression were studied in combination with SES to predict survival while controlling for initial disease severity. These measures were also used in analyses designed to discriminate the psychosocial profile of patients who died early in follow-up from those who died after five years. Data on health behavior profiles and medical care utilization were examined to evaluate the possibility that those factors could account for the relationships between psychosocial characteristics and survival.
Study 2 examined the ability of depressive personality, hostility, and SES to jointly predict acute myocardial infarction (AMI) and mortality in a sample of 730 initially healthy people who had been followed for 30 years. It also investigated the associations of these psychosocial measures with changes in risk factor patterns and health indicators over the follow-up period.
Study 3 administered a large battery of measures to community volunteers in order to document the interrelationships between hostility, depressive personality, and SES in detail. These measures were also used to predict the magnitude and duration of cardiovascular reactivity to mood induction tasks.
The study was renewed in FY 2000 to continue data analysis.
The study has been extended through June, 2009 to conduct four studies that address several questions. All will target significant clinical events such as coronary events and mortality as the primary dependent variables. Two of these are designed to test aspects of a model of mechanisms that account for the connections between stress and health outcomes. One of these is the notion that tangible, social, and psychological resources can moderate stress reactions. This leads to the hypothesis that good social relationships can be especially protective for those of low SES. This will be tested in a large representative population sample (Study One) and a large sample of military veterans. A corollary of this hypothesis is that the interaction of social support and SES should be most apparent in those under high levels of job strain, which will also be tested in the population sample. Both physical health and depressive symptoms will be the outcomes. Another resource is effective coping strategies for stress producing conditions. One of these may be tension reduction through moderate alcohol consumption, a proposition will be examined as an interaction between moderate alcohol usage and job strain in the same sample. Alcohol consumption is also hypothesized to affect health through other pathways in the conceptual model. The investigators have found that some psychosocial variables (hostility and depression) are associated with patterns of binge drinking and alcohol-related behavior problems, although this effect may be moderated by SES. This could account for some of the associations between hostility, depression, and health, a proposition that will be tested in the sample of veterans. The other studies will concentrate on the task of better illuminating the health effects due to particular components of two complex psychosocial variables that are often treated as more global constructs. One study of cardiac patients will rely on an extensive battery of depressive symptom measures collected during hospitalization to predict subsequent cardiac events and mortality. The other is a study of community volunteers who were assessed with a comprehensive set of hostility measures in the early 1990's. These will serve as predictors of subsequent cardiac events and mortality. All studies are expansions of past and current work, building on those findings to test new hypotheses, extend notions based previous findings to the prediction of significant clinical outcomes, and improve our conceptualizations of widely studied psychosocial risk factors.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary Heart Disease Patients | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- coronary heart disease patients --- undergoing angiography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 10 years
Patients were interviewed at hospitalization for psychological status and are being followed for future health/later health.
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 26 Oct 2023.
- Background: PubMed 10749013Brummett BH, Barefoot JC, Feaganes JR, Yen S, Bosworth HB, Williams RB, Siegler IC. Hostility in marital dyads: associations with depressive symptoms. J Behav Med. 2000 Feb;23(1):95-105. doi: 10.1023/a:1005424405056.
- Background: PubMed 9847029Brummett BH, Babyak MA, Barefoot JC, Bosworth HB, Clapp-Channing NE, Siegler IC, Williams RB Jr, Mark DB. Social support and hostility as predictors of depressive symptoms in cardiac patients one month after hospitalization: a prospective study. Psychosom Med. 1998 Nov-Dec;60(6):707-13. doi: 10.1097/00006842-199811000-00008.
- Background: PubMed 11020141Brummett BH, Maynard KE, Haney TL, Siegler IC, Barefoot JC. Reliability of interview-assessed hostility ratings across mode of assessment and time. J Pers Assess. 2000 Oct;75(2):225-36. doi: 10.1207/S15327752JPA7502_4.
- Background: PubMed 10946039Barefoot JC, Brummett BH, Clapp-Channing NE, Siegler IC, Vitaliano PP, Williams RB, Mark DB. Moderators of the effect of social support on depressive symptoms in cardiac patients. Am J Cardiol. 2000 Aug 15;86(4):438-42. doi: 10.1016/s0002-9149(00)00961-9.
- Background: PubMed 11292274Brummett BH, Barefoot JC, Siegler IC, Clapp-Channing NE, Lytle BL, Bosworth HB, Williams RB Jr, Mark DB. Characteristics of socially isolated patients with coronary artery disease who are at elevated risk for mortality. Psychosom Med. 2001 Mar-Apr;63(2):267-72. doi: 10.1097/00006842-200103000-00010.
- Background: PubMed 11138998Barefoot JC, Brummett BH, Helms MJ, Mark DB, Siegler IC, Williams RB. Depressive symptoms and survival of patients with coronary artery disease. Psychosom Med. 2000 Nov-Dec;62(6):790-5. doi: 10.1097/00006842-200011000-00008.
- Background: PubMed 11405320Barefoot JC, Mortensen EL, Helms MJ, Avlund K, Schroll M. A longitudinal study of gender differences in depressive symptoms from age 50 to 80. Psychol Aging. 2001 Jun;16(2):342-5. doi: 10.1037//0882-7974.16.2.342.
- Background: PubMed 12145024Barefoot JC, Gronbaek M, Feaganes JR, McPherson RS, Williams RB, Siegler IC. Alcoholic beverage preference, diet, and health habits in the UNC Alumni Heart Study. Am J Clin Nutr. 2002 Aug;76(2):466-72. doi: 10.1093/ajcn/76.2.466.
- Background: PubMed 12042680Brummett BH, Babyak MA, Mark DC, Williams RB, Siegler IC, Clapp-Channing N, Barefoot JC. Predictors of smoking cessation in patients with a diagnosis of coronary artery disease. J Cardiopulm Rehabil. 2002 May-Jun;22(3):143-7. doi: 10.1097/00008483-200205000-00003.
- Background: PubMed 11978677Surwit RS, Williams RB, Siegler IC, Lane JD, Helms M, Applegate KL, Zucker N, Feinglos MN, McCaskill CM, Barefoot JC. Hostility, race, and glucose metabolism in nondiabetic individuals. Diabetes Care. 2002 May;25(5):835-9. doi: 10.2337/diacare.25.5.835.
- Background: PubMed 10863676Fredrickson BL, Maynard KE, Helms MJ, Haney TL, Siegler IC, Barefoot JC. Hostility predicts magnitude and duration of blood pressure response to anger. J Behav Med. 2000 Jun;23(3):229-43. doi: 10.1023/a:1005596208324.
- Background: PubMed 14570955Williams RB, Barefoot JC, Schneiderman N. Psychosocial risk factors for cardiovascular disease: more than one culprit at work. JAMA. 2003 Oct 22;290(16):2190-2. doi: 10.1001/jama.290.16.2190. No abstract available.
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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.
John Barefoot, PhD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Coronary Disease, run by Duke University.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2023. 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?
Mortality (time frame: 10 years). 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 NCT00005533, which also lists 14 linked publications.
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 26 Oct 2023.