Stress Clinical Trial
Official title:
Effectiveness of Mental Stress Reduction in Defibrillator Patients
Verified date | December 2014 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 129 |
Est. completion date | July 2014 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 85 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Wlliam S. Middleton Memorial Veterans Hospital, Madison | Madison | Wisconsin |
United States | Zablocki VA Medical Center, Milwaukee | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Immediate to 6 months post intervention | No |
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. | 3 months post intervention | No |
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 | Immediate to 6 months post intervention | No |
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.. | Immediate post intervention | No |
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 | No |
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 | No |
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 | No |
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 | No |
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. | 6 months post intervention | No |
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. | 6 months post intervention | No |
Secondary | Cardioverter-DefibrillatorTherapies | Cardioverter-Defibrillator therapies for treatment of serious ventricular arrhythmia | 6 months post intervention | No |
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