Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Mental Stress Reduction in Defibrillator Patients

This study has been terminated.
(Exhaustion of subject population pool, 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: December 15, 2014
Last verified: December 2014
  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: Patient Education
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:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Mental Stress Induced Elevation in "Double Product" by Math Stress Task [ Time Frame: Immediate to 6 months post intervention ] [ Designated as safety issue: No ]
    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.

  • Mental Stress Induced Elevation in Double Product by Math Stress Task [ Time Frame: 3 months post intervention ] [ Designated as safety issue: No ]
    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.

  • Mental Stress Induced Elevation in "Double Product" by Anger-recall Task [ Time Frame: Immediate to 6 months post intervention ] [ Designated as safety issue: No ]
    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:
  • State Anger [ Time Frame: Immediate post intervention ] [ Designated as safety issue: No ]
    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..

  • Tension/Anxiety [ Time Frame: Immediate post intervention ] [ Designated as safety issue: No ]
    Psychometric score by self-report questionnaire Scale range is 3-29. Lower values represent better outcome, and higher values represent worse outcome..

  • Perceived Stress [ Time Frame: Immediate post intervention ] [ Designated as safety issue: No ]
    Psychometric score from self-report questionnaire Scale range is 2-27. Lower values represent better outcome, and higher values represent worse outcome..

  • Depression/Dejection [ Time Frame: 3 months post intervention ] [ Designated as safety issue: No ]
    Psychometric score from self-report questionnaire Scale range is 9 to 60. Lower values represent better outcome, and higher values represent worse outcome..

  • Low Frequency Heart Rate Variability [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]

    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.


  • High Frequency Heart Rate Variability [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
    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.

  • Low Frequency/High Frequency Ratio of Heart Rate Variability [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
    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.

  • Cardioverter-DefibrillatorTherapies [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
    Cardioverter-Defibrillator therapies for treatment of serious ventricular arrhythmia


Enrollment: 129
Study Start Date: September 2008
Study Completion Date: July 2014
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

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, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Results First Received: November 19, 2014
Last Updated: December 15, 2014
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:
Cardiomyopathies
Cardiomyopathy, Dilated
Stress, Psychological
Behavioral Symptoms
Cardiomegaly
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on February 25, 2015