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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 )

Tracking Information
First Submitted Date  ICMJE February 14, 2008
First Posted Date  ICMJE February 27, 2008
Results First Submitted Date  ICMJE November 19, 2014
Results First Posted Date  ICMJE December 22, 2014
Last Update Posted Date December 22, 2014
Study Start Date  ICMJE September 2008
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2014)
  • 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.
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2008)
Heart Rate and Blood pressure ("Double product" of Hear Rate x Systolic Blood pressure) response to Mental Stress testing [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT00624520 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2014)
  • 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..
  • 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..
  • 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..
  • 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..
  • 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.
  • 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.
  • 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.
  • Cardioverter-DefibrillatorTherapies [ Time Frame: 6 months post intervention ]
    Cardioverter-Defibrillator therapies for treatment of serious ventricular arrhythmia
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mental Stress Reduction in Defibrillator Patients
Official Title  ICMJE Effectiveness of Mental Stress Reduction in Defibrillator Patients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiomyopathy, Dilated
  • Arrhythmia
  • Anger
  • Stress
Intervention  ICMJE
  • Behavioral: Cognitive Behavioral Stress Management (CBSM)
    10 week program of weekly CBSM therapy group sessions
  • Other: Patient Education
    10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.
Study Arms  ICMJE
  • Active Comparator: Cognitive Behavioral Stress Management
    10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions
    Intervention: Behavioral: Cognitive Behavioral Stress Management (CBSM)
  • Active Comparator: Patient Education
    10 week program of once weekly Patient Education group sessions
    Intervention: Other: Patient Education
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 23, 2012)
129
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2008)
138
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00624520
Other Study ID Numbers  ICMJE CLIN-008-07F
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VA Office of Research and Development ( US Department of Veterans Affairs )
Study Sponsor  ICMJE US Department of Veterans Affairs
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Douglas Russell, MD PhD Wlliam S. Middleton Memorial Veterans Hospital, Madison
PRS Account VA Office of Research and Development
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP