Mental Stress Reduction in Defibrillator Patients
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Age >21 years,
- ICD Implantation,
- > 3 months following ICD implantation,
- willingness to give informed consent
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
129 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal