NCT00624520

Mental Stress Reduction in Defibrillator Patients

Effectiveness of Mental Stress Reduction in Defibrillator Patients

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effectiveness of a 10 week program of Stress Management versus control Patient Education sessions on cardiac responses to mental stress in veterans with Implantable Cardioverter-Defibrillators

Detailed description

The study is a randomized controlled small clinical trial designed to determine whether a 10-week program of group cognitive-behavioral stress management (CBSM) versus a control "Patient Education" program can improve hemodynamic responses to mental stress testing in patients with Implantable Cardioverter Defibrillators. Comparison will be made between groups of heart rate and blood pressure responses to mental arithmetic and anger-recall mental stress, psychometric profiles, arrhythmia frequency and implantable cardioverter defibrillator firings before, immediately and up to 6 months after intervention. If benefit of CBSM is proven, study findings could lead to wider use of stress management programs, with increased life expectancy for implantable cardioverter-defibrillator patients.

Conditions

• Cardiomyopathy, Dilated
• Arrhythmia
• Anger
• Stress

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Stress Management (CBSM)	10 week program of weekly CBSM therapy group sessions
OTHER	Patient Education	10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-05-01
• Completion: 2014-07-01
• First posted: 2008-02-27
• Last updated: 2014-12-22
• Results posted: 2014-12-22

Locations

2 sites across 1 country: United States