Status:
TERMINATED
Mental Stress Reduction in Defibrillator Patients
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Cardiomyopathy, Dilated
Arrhythmia
Eligibility:
All Genders
21-85 years
Phase:
PHASE3
Brief 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 Impl...
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" pr...
Eligibility Criteria
Inclusion
- Age \>21 years,
- ICD Implantation,
- \> 3 months following ICD implantation,
- willingness to give informed consent
Exclusion
- Episodes within prior 3 months of: acute coronary syndrome, myocardial infraction, Coronary Artery By-pass Graft surgery, percutaneous coronary intervention, hospital admission any cause,
- severe mental illness,
- life expectancy \< 1 year,
- hyperkalemia,
- hypokalemia,
- hypomagnesemia,
- hypermagnesemia,
- unwillingness to give informed consent
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT00624520
Start Date
September 1 2008
End Date
July 1 2014
Last Update
December 22 2014
Active Locations (2)
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1
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Madison, Wisconsin, United States, 53705
2
Zablocki VA Medical Center, Milwaukee
Milwaukee, Wisconsin, United States, 53295-1000