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Mental Stress Reduction in Defibrillator Patients

Primary Purpose

Cardiomyopathy, Dilated, Arrhythmia, Anger

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Stress Management (CBSM)
Patient Education
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiomyopathy, Dilated focused on measuring Stress, Psychological, Tachycardia, Ventricular, Defibrillators, Implantable, Death, Sudden Cardiac, Cognitive Therapy, Anger

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wlliam S. Middleton Memorial Veterans Hospital, Madison
  • Zablocki VA Medical Center, Milwaukee

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cognitive Behavioral Stress Management

Patient Education

Arm Description

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

10 week program of once weekly Patient Education group sessions

Outcomes

Primary Outcome Measures

Mental Stress Induced Elevation in "Double Product" by Math Stress Task
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
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
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
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
Psychometric score by self-report questionnaire Scale range is 3-29. Lower values represent better outcome, and higher values represent worse outcome..
Perceived Stress
Psychometric score from self-report questionnaire Scale range is 2-27. Lower values represent better outcome, and higher values represent worse outcome..
Depression/Dejection
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
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
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
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
Cardioverter-Defibrillator therapies for treatment of serious ventricular arrhythmia

Full Information

First Posted
February 14, 2008
Last Updated
December 15, 2014
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00624520
Brief Title
Mental Stress Reduction in Defibrillator Patients
Official Title
Effectiveness of Mental Stress Reduction in Defibrillator Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
Exhaustion of subject population pool, greater than expected drop-out rates . Data analysis approved by DMC for study completions
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathy, Dilated, Arrhythmia, Anger, Stress
Keywords
Stress, Psychological, Tachycardia, Ventricular, Defibrillators, Implantable, Death, Sudden Cardiac, Cognitive Therapy, Anger

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Stress Management
Arm Type
Active Comparator
Arm Description
10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions
Arm Title
Patient Education
Arm Type
Active Comparator
Arm Description
10 week program of once weekly Patient Education group sessions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Stress Management (CBSM)
Intervention Description
10 week program of weekly CBSM therapy group sessions
Intervention Type
Other
Intervention Name(s)
Patient Education
Intervention Description
10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.
Primary Outcome Measure Information:
Title
Mental Stress Induced Elevation in "Double Product" by Math Stress Task
Description
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.
Time Frame
Immediate to 6 months post intervention
Title
Mental Stress Induced Elevation in Double Product by Math Stress Task
Description
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.
Time Frame
3 months post intervention
Title
Mental Stress Induced Elevation in "Double Product" by Anger-recall Task
Description
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
Time Frame
Immediate to 6 months post intervention
Secondary Outcome Measure Information:
Title
State Anger
Description
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..
Time Frame
Immediate post intervention
Title
Tension/Anxiety
Description
Psychometric score by self-report questionnaire Scale range is 3-29. Lower values represent better outcome, and higher values represent worse outcome..
Time Frame
Immediate post intervention
Title
Perceived Stress
Description
Psychometric score from self-report questionnaire Scale range is 2-27. Lower values represent better outcome, and higher values represent worse outcome..
Time Frame
Immediate post intervention
Title
Depression/Dejection
Description
Psychometric score from self-report questionnaire Scale range is 9 to 60. Lower values represent better outcome, and higher values represent worse outcome..
Time Frame
3 months post intervention
Title
Low Frequency Heart Rate Variability
Description
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.
Time Frame
6 months post intervention
Title
High Frequency Heart Rate Variability
Description
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.
Time Frame
6 months post intervention
Title
Low Frequency/High Frequency Ratio of Heart Rate Variability
Description
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.
Time Frame
6 months post intervention
Title
Cardioverter-DefibrillatorTherapies
Description
Cardioverter-Defibrillator therapies for treatment of serious ventricular arrhythmia
Time Frame
6 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Russell, MD PhD
Organizational Affiliation
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wlliam S. Middleton Memorial Veterans Hospital, Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Zablocki VA Medical Center, Milwaukee
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295-1000
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26010524
Citation
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.
Results Reference
derived

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Mental Stress Reduction in Defibrillator Patients

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