Clinical trial NCT00624520: Mental Stress Reduction in Defibrillator Patients
Official title: Effectiveness of Mental Stress Reduction in Defibrillator Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cardiomyopathy, Dilated
Arrhythmia
Anger
Stress
Keywords: Stress, Psychological
Tachycardia, Ventricular
Defibrillators, Implantable
Death, Sudden Cardiac
Cognitive Therapy
Anger
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-02-27
Enrollment: 129
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mental Stress Induced Elevation in "Double Product" by Math Stress Task
timeFrame: Immediate to 6 months post intervention
measure: Mental Stress Induced Elevation in Double Product by Math Stress Task
timeFrame: 3 months post intervention
measure: Mental Stress Induced Elevation in "Double Product" by Anger-recall Task
timeFrame: Immediate to 6 months post intervention
Secondary outcomes:
measure: State Anger
timeFrame: Immediate post intervention
measure: Tension/Anxiety
timeFrame: Immediate post intervention
measure: Perceived Stress
timeFrame: Immediate post intervention
measure: Depression/Dejection
timeFrame: 3 months post intervention
measure: Low Frequency Heart Rate Variability
timeFrame: 6 months post intervention
measure: High Frequency Heart Rate Variability
timeFrame: 6 months post intervention
measure: Low Frequency/High Frequency Ratio of Heart Rate Variability
timeFrame: 6 months post intervention
measure: Cardioverter-DefibrillatorTherapies
timeFrame: 6 months post intervention
Other outcomes:
Locations:
city: Madison
country: United States
facility: Wlliam S. Middleton Memorial Veterans Hospital, Madison
state: Wisconsin
city: Milwaukee
country: United States
facility: Zablocki VA Medical Center, Milwaukee
state: Wisconsin
Study officials:
affiliation: Wlliam S. Middleton Memorial Veterans Hospital, Madison
name: Douglas Russell, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Russell DC, Smith TL, Krahn DD, Graskamp P, Singh D, Kolden GG, Sigmund H, Zhang Z. Effects of Cognitive Behavioral Stress Management on Negative Mood and Cardiac Autonomic Activity in ICD Recipients. Pacing Clin Electrophysiol. 2015 Aug;38(8):951-65. doi: 10.1111/pace.12668. Epub 2015 Jun 20.