Framingham Offspring Study: Psychosocial Risk Factors

Depression Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00037323
• Other study ID #: 1162
• Secondary ID: R03HL067426
• Status: Completed
• Phase: N/A
• First received: May 16, 2002
• Last updated: March 15, 2016
• Start date: May 2001
• Est. completion date: October 2003

Study information

• Verified date: May 2004
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

To examine the relationship between psychosocial characteristics, health behaviors, and the development of coronary heart disease among participants in the Framingham Offspring Study.

Description:

DESIGN NARRATIVE:

Unique data sets of social, psychological, and behavioral measures were collected at the third examination of the Offspring Study from 1984 through 1987 (which results in 14 to 17 years of follow-up). Hypotheses for this research are focused toward understanding the sex and age differences in the effects these variables have on health endpoints. The research questions involve the prediction of three separate endpoints: incidence of coronary heart disease; the incidence and prognosis of atrial fibrillation; and total mortality. The analyses of psychosocial predictors for these outcomes are divided into four conceptual areas: 1) occupational status and strain, income, and employment status; 2) type A behavior, expressions of anger, hostility, and rate; 3) symptoms of depression, tension, anxiety, and feelings of aloneness; and 4) marital relationships and marital strain. These psychosocial variables will be analyzed jointly with the physiological risk factors collected at the same time to assess independence and interaction of effects. To date these psychosocial data have not been analyzed or published.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 100 Years
• Eligibility: No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Depression
• Heart Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (2)

Eaker ED, Sullivan LM, Kelly-Hayes M, D'Agostino RB Sr, Benjamin EJ. Anger and hostility predict the development of atrial fibrillation in men in the Framingham Offspring Study. Circulation. 2004 Mar 16;109(10):1267-71. Epub 2004 Mar 1. — View Citation

Eaker ED, Sullivan LM, Kelly-Hayes M, D'Agostino RB Sr, Benjamin EJ. Does job strain increase the risk for coronary heart disease or death in men and women? The Framingham Offspring Study. Am J Epidemiol. 2004 May 15;159(10):950-8. — View Citation