NCT00365196

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 1999

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
6.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
Last Updated

February 18, 2016

Status Verified

December 1, 2007

First QC Date

August 16, 2006

Last Update Submit

February 17, 2016

Conditions

Keywords

Autonomic Nervous System

Outcome Measures

Primary Outcomes (1)

  • Cardiac autonomic regulation (measured at Week 12 and at 6-month follow-up evaluation)

Interventions

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Psychiatric disorder
  • Currently taking psychiatric medications
  • Currently taking cardioactive medications
  • Medical condition that affects the ANS
  • Currently taking medications that affect the cardiovascular system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Richard P. Sloan, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 16, 2006

First Posted

August 17, 2006

Study Start

December 1, 1999

Study Completion

January 1, 2006

Last Updated

February 18, 2016

Record last verified: 2007-12