Mental Stress Reduction in Defibrillator Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of Mental Stress Reduction in Defibrillator Patients

Conditions
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Cardiomyopathy, Dilated, Arrhythmia, Anger, Stress

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Stress Management (CBSM)
* Other: Patient Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive Behavioral Stress Management<br>10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions | Behavioral: Cognitive Behavioral Stress Management (CBSM)<br>* 10 week program of weekly CBSM therapy group sessions<br>|
| Active Comparator: Patient Education<br>10 week program of once weekly Patient Education group sessions | Other: Patient Education<br>* 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Immediate to 6 months post intervention | 
| 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. | 3 months post intervention | 
| 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 | Immediate to 6 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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.. | Immediate post intervention | 
| Tension/Anxiety | Psychometric score by self-report questionnaire Scale range is 3-29. Lower values represent better outcome, and higher values represent worse outcome.. | Immediate post intervention | 
| Perceived Stress | Psychometric score from self-report questionnaire Scale range is 2-27. Lower values represent better outcome, and higher values represent worse outcome.. | Immediate post intervention | 
| 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.. | 3 months post intervention | 
| 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. | 6 months post intervention | 
| 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. | 6 months post intervention | 
| 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. | 6 months post intervention | 
| Cardioverter-DefibrillatorTherapies | Cardioverter-Defibrillator therapies for treatment of serious ventricular arrhythmia | 6 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress, Psychological, Tachycardia, Ventricular, Defibrillators, Implantable, Death, Sudden Cardiac, Cognitive Therapy, Anger