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Exhaustion of subject population pool, greater than expected drop-out rates . Data analysis approved by DMC for study completions
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Stress Management | Active Comparator | 10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions |
|
| Patient Education | Active Comparator | 10 week program of once weekly Patient Education group sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Stress Management (CBSM) | Behavioral | 10 week program of weekly CBSM therapy group sessions |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Russell, MD PhD | Wlliam S. Middleton Memorial Veterans Hospital, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wlliam S. Middleton Memorial Veterans Hospital, Madison | Madison | Wisconsin | 53705 | United States | ||
| Zablocki VA Medical Center, Milwaukee |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26010524 | Derived | 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. |
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Some enrolled participants were excluded from the trial if determined to have severe mental illness after administration of an SCID-I questionnaire and/or interview by a clinical psychologist. Others were excluded as drop-outs due to travel issues, weather, family issues, and illness. 2 subjects died before group assignment.
Recruitment commenced October 2009, completed December 2011 Recruitment from Cardiology Clinics W S Middleton Veterans Hospital, Madison, and Zablocki VA Medical Center, Milwaukee
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Behavioral Stress Management | 10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions |
| FG001 | Patient Education | 10 week program of once weekly Patient Education group sessions Patient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects randomized , including drop-outs before commencement of intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Behavioral Stress Management | 10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions |
| BG001 | Patient Education |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Response to Mental Stress by Math Stress Task. | Posted | Mean | Standard Error | mmHg x beats/min | Immediate to 6 months post intervention |
|
6 to 12 months, from enrollment to study completion
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Behavioral Stress Management | 10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Non-systematic Assessment | Cardiomyopathy, sudden cardiac death |
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Early termination of study after 12 month study extension and interim data analysis, due to high drop-out rate and exhaustion of population pool, 9 subjects short of revised target enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Douglas C Russell | Department of Veterans Affairs | 608-256-1901 | Dcrussel@facstaff.wisc.edu |
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| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| D001145 | Arrhythmias, Cardiac |
| D013315 | Stress, Psychological |
| D017180 | Tachycardia, Ventricular |
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
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| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Patient Education | Other | 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease. |
|
| Immediate to 6 months post intervention |
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 |
| Milwaukee |
| Wisconsin |
| 53295-1000 |
| United States |
10 week program of once weekly Patient Education group sessions Patient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Madison and Milwaukee study sites, US | Number | participants |
|
| Cognitive Behavioral Stress Management |
10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions |
| OG001 | Patient Education | 10 week program of once weekly Patient Education group sessions Patient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease. |
|
|
|
| Secondary | 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.. | Serial psychometric scores up to 6 months post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up, with inclusion only of participants having accurate and appropriate data. | Posted | Mean | Standard Deviation | units on a scale | Immediate post intervention |
|
|
|
|
| Secondary | 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 Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up, with inclusion only of participants having accurate and appropriate data. | Posted | Mean | Standard Deviation | units on a scale | Immediate post intervention |
|
|
|
|
| Secondary | 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 Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up, with inclusion only of participants having accurate and appropriate data. | Posted | Mean | Standard Deviation | units on a scale | Immediate post intervention |
|
|
|
|
| Secondary | 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 Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up,with inclusion only of participants having accurate and appropriate data. | Posted | Mean | Standard Deviation | units on a scale | 3 months post intervention |
|
|
|
|
| Secondary | 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, from ECG recordings during mental stress tasks Reduced numbers of participants analyzed reflect drop-outs or non-diagnostic recordings for HRV analyses during follow-up, with inclusion only of participants having accurate and appropriate data. | Posted | Mean | Standard Deviation | percentage of spectral power | 6 months post intervention |
|
|
|
|
| Secondary | 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. | Reduced participant numbers reflect drop-outs and exclusion of participants with non-diagnostic recordings for HRV analyses, with inclusion only of participants having accurate and appropriate data. | Posted | Mean | Standard Deviation | percentage of spectral power | 6 months post intervention |
|
|
|
|
| Secondary | 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. | Reduced numbers of participants analyzed reflect drop-outs or non-diagnostic recordings for heart rate variability analyses during follow-up, with inclusion only of participants having accurate and appropriate data. Data are shown for Ratios of Low and High Frequency power shown above. | Posted | Mean | Standard Deviation | Ratio | 6 months post intervention |
|
|
|
|
| Secondary | Cardioverter-DefibrillatorTherapies | Cardioverter-Defibrillator therapies for treatment of serious ventricular arrhythmia | Cardioverter-defibrillator interrogation data between 3 and 6 months post intervention | Posted | Number | percentage of participants | 6 months post intervention |
|
|
|
|
| Primary | 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. | Response to mental stress by math task testing at 3 months post intervention, compared with pre-intervention. Within-group comparison is shown for matched pair data. The lower number of participants analyzed than at study entry is due to patient drop-outs during follow-up post-intervention. | Posted | Mean | Standard Error | mmHg x beats/minute | 3 months post intervention |
|
|
|
|
| Primary | 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 | Response to Mental Stress by Anger-Recall Stress Task | Posted | Mean | Standard Error | mmHg x beats/minute | Immediate to 6 months post intervention |
|
|
|
|
| 9 |
| 56 |
| 0 |
| 56 |
| EG001 | Patient Education | 10 week program of once weekly Patient Education group sessions Patient Education: 10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease. | 12 | 47 | 0 | 47 |
|
| Atrial flutter | Cardiac disorders | Non-systematic Assessment | Includes Ablation procedures |
|
| Ventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | Non-systematic Assessment | Tachycardia unknown origin |
|
| Heart Failure | Cardiac disorders | Non-systematic Assessment |
|
| Dizziness | Cardiac disorders | Non-systematic Assessment | Includes syncope, dizziness, hypotension |
|
| Implantable Defibrillator malfunction | Cardiac disorders | Non-systematic Assessment | Includes admissions for inappropriate device firings, lead revisions |
|
| Diverticulitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Esophageal stricture | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment | Includes colonoscopy |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Carotid artery disease | Vascular disorders | Non-systematic Assessment | Includes carotid artery surgery |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | includes respiratory infection |
|
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Includes nasal polypectomy |
|
| Cerebrovascular Disease | Vascular disorders | Non-systematic Assessment |
|
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| D000083083 |
| Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
| D003643 | Death |
| Immediate post intervention |
|