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Mental Stress Reduction in Defibrillator Patients

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ClinicalTrials.gov Identifier: NCT00624520
Recruitment Status : Terminated (Exhaustion of subject population pool, greater than expected drop-out rates . Data analysis approved by DMC for study completions)
First Posted : February 27, 2008
Results First Posted : December 22, 2014
Last Update Posted : December 22, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description
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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

Condition or disease Intervention/treatment Phase
Cardiomyopathy, Dilated Arrhythmia Anger Stress Behavioral: Cognitive Behavioral Stress Management (CBSM) Other: Patient Education Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Mental Stress Reduction in Defibrillator Patients
Study Start Date : September 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stress

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Cognitive Behavioral Stress Management
10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions
 Behavioral: Cognitive Behavioral Stress Management (CBSM)
10 week program of weekly CBSM therapy group sessions
Active Comparator: Patient Education
10 week program of once weekly Patient Education group sessions
 Other: Patient Education
10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.


Outcome Measures
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Primary Outcome Measures :
  1. Mental Stress Induced Elevation in "Double Product" by Math Stress Task [ Time Frame: Immediate to 6 months post intervention ]
    Maximum Mental Stress induced elevation in "Double Product" , (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress task of mental arithmetic (serial subtraction). Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The math task was applied for 10 minutes, with 10 minutes recovery time. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect.

  2. Mental Stress Induced Elevation in Double Product by Math Stress Task [ Time Frame: 3 months post intervention ]
    Maximum Mental Stress induced elevation in "Double Product" , DP, (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress tasks of mental arithmetic (serial subtraction). Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The math task was applied for 10 minutes, with 10 minutes recovery time. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect.

  3. Mental Stress Induced Elevation in "Double Product" by Anger-recall Task [ Time Frame: Immediate to 6 months post intervention ]
    Maximum Mental Stress induced elevation in "Double Product" , (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress of anger-recall task. Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The anger-recall test was applied for 25 minutes with 10 minutes monitoring post-test. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect


Secondary Outcome Measures :
  1. State Anger [ Time Frame: Immediate post intervention ]
    Psychosocial score of negative mood derived from self-report questionnaires. Scale range was 15-45. Lower values represent better outcome, and higher values represent worse outcome..

  2. Tension/Anxiety [ Time Frame: Immediate post intervention ]
    Psychometric score by self-report questionnaire Scale range is 3-29. Lower values represent better outcome, and higher values represent worse outcome..

  3. Perceived Stress [ Time Frame: Immediate post intervention ]
    Psychometric score from self-report questionnaire Scale range is 2-27. Lower values represent better outcome, and higher values represent worse outcome..

  4. Depression/Dejection [ Time Frame: 3 months post intervention ]
    Psychometric score from self-report questionnaire Scale range is 9 to 60. Lower values represent better outcome, and higher values represent worse outcome..

  5. Low Frequency Heart Rate Variability [ Time Frame: 6 months post intervention ]

    Heart Rate Variability measure of cardiac autonomic activity, believed to reflect a combination of cardiac sympathetic and parasympathetic activity.

    Data are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Low frequency heart rate variability correlates with cardiac sympathetic and parasympathetic activity. Increased sympathetic activity and/or decreased parasympathetic activity occur in this study population at high risk for cardiac arrhythmia. Normalized units are used, reflecting percentage of total frequency power.


  6. High Frequency Heart Rate Variability [ Time Frame: 6 months post intervention ]
    Heart Rate Variability measure of Cardiac Parasympathetic activity. Data are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Increased High Frequency heart rate variability correlates with increased cardiac parasympathetic activity. Normalized units are used, reflecting percentage of total frequency power.

  7. Low Frequency/High Frequency Ratio of Heart Rate Variability [ Time Frame: 6 months post intervention ]
    Heart Rate Variability measure of cardiac autonomic activity Data are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Decreased Low/High Frequency ratio reflects Increased High Frequency heart rate variability which correlates with increased cardiac parasympathetic activity, which may be beneficial in this patient population. Normalized units are used, reflecting percentage of total frequency power.

  8. Cardioverter-DefibrillatorTherapies [ Time Frame: 6 months post intervention ]
    Cardioverter-Defibrillator therapies for treatment of serious ventricular arrhythmia


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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, 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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00624520


Locations
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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
US Department of Veterans Affairs
Investigators
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Principal Investigator: Douglas Russell, MD PhD Wlliam S. Middleton Memorial Veterans Hospital, Madison
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: US Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00624520    
Other Study ID Numbers: CLIN-008-07F
First Posted: February 27, 2008    Key Record Dates
Results First Posted: December 22, 2014
Last Update Posted: December 22, 2014
Last Verified: December 2014
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
Stress, Psychological
Tachycardia, Ventricular
Defibrillators, Implantable
 Death, Sudden Cardiac
Cognitive Therapy
Anger
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Dilated
Stress, Psychological
Heart Diseases
Cardiovascular Diseases
 Behavioral Symptoms
Cardiomegaly
Laminopathies
Genetic Diseases, Inborn