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Mental Stress Reduction in Defibrillator Patients

NCT ID: NCT00624520

Last Updated: 2014-12-22

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2014-07-31

Brief Summary

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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

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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

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Cardiomyopathy, Dilated Arrhythmia Anger Stress

Keywords

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Stress, Psychological Tachycardia, Ventricular Defibrillators, Implantable Death, Sudden Cardiac Cognitive Therapy Anger

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cognitive Behavioral Stress Management

10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Stress Management (CBSM)

Intervention Type BEHAVIORAL

10 week program of weekly CBSM therapy group sessions

Patient Education

10 week program of once weekly Patient Education group sessions

Group Type ACTIVE_COMPARATOR

Patient Education

Intervention Type OTHER

10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.

Interventions

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Cognitive Behavioral Stress Management (CBSM)

10 week program of weekly CBSM therapy group sessions

Intervention Type BEHAVIORAL

Patient Education

10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Douglas Russell, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Wlliam S. Middleton Memorial Veterans Hospital, Madison

Locations

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Wlliam S. Middleton Memorial Veterans Hospital, Madison

Madison, Wisconsin, United States

Site Status

Zablocki VA Medical Center, Milwaukee

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26010524 (View on PubMed)

Other Identifiers

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CLIN-008-07F

Identifier Type: -

Identifier Source: org_study_id