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Mental Stress Reduction in Defibrillator Patients

This study has been terminated.
(Exhaustion of subject population pool, with greater than expected drop-out rates . Data analysis approved by DMC for study completions)
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00624520
First received: February 14, 2008
Last updated: July 23, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Cardiomyopathy, Dilated
Arrhythmia
Anger
Stress
 Behavioral: Cognitive Behavioral Stress Management (CBSM)
Other: Control "Patient Education" program
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Mental Stress Reduction in Defibrillator Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Heart Rate and Blood pressure ("Double product" of Heart Rate x Systolic Blood pressure) response to Mental Stress testing [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Mental Stress induced elevation in product of Heart Rate and Systolic Arterial Blood Pressure ("Double product")


Enrollment: 129
Study Start Date: September 2008
Estimated Study Completion Date: June 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
10 week program of once weekly stress management therapy (CBSM)
 Behavioral: Cognitive Behavioral Stress Management (CBSM)
10 week program of weekly CBSM therapy group sessions
Active Comparator: Arm 2
10 week program of once weekly Patient Education group sessions
 Other: Control "Patient Education" program
10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.

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 ICD 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 ICD patients.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, CABG surgery, percutaneous coronary intervention, hospital admission any cause,
  • severe mental illness,
  • life expectancy < 1 year,
  • hyperkalemia,
  • hypokalemia,
  • hypomagnesemia,
  • hypermagnesemia,
  • unwillingness to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00624520

Locations
United States, Wisconsin
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Madison, Wisconsin, United States, 53705
Zablocki VA Medical Center, Milwaukee
Milwaukee, Wisconsin, United States, 53295-1000
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Douglas Russell, MD PhD Wlliam S. Middleton Memorial Veterans Hospital, Madison
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00624520     History of Changes
Other Study ID Numbers: CLIN-008-07F
Study First Received: February 14, 2008
Last Updated: July 23, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Stress, Psychological
Tachycardia, Ventricular
Defibrillators, Implantable
 Death, Sudden Cardiac
Cognitive Therapy
Anger

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Cardiomyopathy, Dilated
Stress, Psychological
Cardiomyopathies
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Cardiomegaly
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 16, 2013