Anger, Arrhythmia, Cardiomyopathy, Dilated, Stress
Conditions
Keywords
Stress, Psychological, Tachycardia, Ventricular, Defibrillators, Implantable, Death, Sudden Cardiac, Cognitive Therapy, Anger
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.
Interventions
10 week program of weekly CBSM therapy group sessions
OTHERPatient Education
10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mental Stress Induced Elevation in Double Product by Math Stress Task | 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 Anger-recall Task | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress | 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 | 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 | 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. |
| State Anger | 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.. |
| Low Frequency/High Frequency Ratio of Heart Rate Variability | 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 | 6 months post intervention | Cardioverter-Defibrillator therapies for treatment of serious ventricular arrhythmia |
| High Frequency Heart Rate Variability | 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. |
| Tension/Anxiety | 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.. |
Countries
United States
Participant flow
Recruitment details
Recruitment commenced October 2009, completed December 2011 Recruitment from Cardiology Clinics W S Middleton Veterans Hospital, Madison, and Zablocki VA Medical Center, Milwaukee
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 56 |
| 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. | 47 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Withdrawal by Subject | 12 | 7 |
Baseline characteristics
| Characteristic | Cognitive Behavioral Stress Management | Patient Education | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 24 Participants | 24 Participants | 48 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 23 Participants | 55 Participants |
| Age, Continuous | 65.7 Years STANDARD_DEVIATION 9 | 66.2 Years STANDARD_DEVIATION 8.6 | 65.7 Years STANDARD_DEVIATION 8.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 45 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 6 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 51 Participants | 41 Participants | 92 Participants |
| Region of Enrollment United States | 56 participants | 47 participants | 103 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 56 Participants | 46 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 56 | 0 / 47 |
| serious Total, serious adverse events | 9 / 56 | 12 / 47 |
Outcome results
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
Time frame: Immediate to 6 months post intervention
Population: Response to Mental Stress by Anger-Recall Stress Task
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavioral Stress Management | Mental Stress Induced Elevation in Double Product by Anger-recall Task | 6 months post intervention | 711 mmHg x beats/minute | Standard Error 232 |
| Cognitive Behavioral Stress Management | Mental Stress Induced Elevation in Double Product by Anger-recall Task | 3 months post intervention | 353 mmHg x beats/minute | Standard Error 167 |
| Cognitive Behavioral Stress Management | Mental Stress Induced Elevation in Double Product by Anger-recall Task | Immediate post intervention | 406 mmHg x beats/minute | Standard Error 93 |
| Patient Education | Mental Stress Induced Elevation in Double Product by Anger-recall Task | 6 months post intervention | 631 mmHg x beats/minute | Standard Error 292 |
| Patient Education | Mental Stress Induced Elevation in Double Product by Anger-recall Task | 3 months post intervention | 548 mmHg x beats/minute | Standard Error 308 |
| Patient Education | Mental Stress Induced Elevation in Double Product by Anger-recall Task | Immediate post intervention | 681 mmHg x beats/minute | Standard Error 244 |
Comparison: Initial sample size calculation, based on previous published data of effects sizes of anger stress management on heart rate and blood pressure responses in a veteran population, indicated a study population of 138 patients should detect a reduction in Double Product response to mental stress following psychological intervention, with over 90% power, assuming 20% drop-out rate.p-value: 0.81ANOVA
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.
Time frame: Immediate to 6 months post intervention
Population: Response to Mental Stress by Math Stress Task.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavioral Stress Management | Mental Stress Induced Elevation in Double Product by Math Stress Task | 6 months post | 1693 mmHg x beats/min | Standard Error 343 |
| Cognitive Behavioral Stress Management | Mental Stress Induced Elevation in Double Product by Math Stress Task | 3 months post | 1399 mmHg x beats/min | Standard Error 201 |
| Cognitive Behavioral Stress Management | Mental Stress Induced Elevation in Double Product by Math Stress Task | Immediate post | 1514 mmHg x beats/min | Standard Error 246 |
| Patient Education | Mental Stress Induced Elevation in Double Product by Math Stress Task | 6 months post | 1137 mmHg x beats/min | Standard Error 228 |
| Patient Education | Mental Stress Induced Elevation in Double Product by Math Stress Task | 3 months post | 1063 mmHg x beats/min | Standard Error 158 |
| Patient Education | Mental Stress Induced Elevation in Double Product by Math Stress Task | Immediate post | 1538 mmHg x beats/min | Standard Error 224 |
Comparison: Initial sample size calculation, based on previous published data of effects sizes of anger stress management on heart rate and blood pressure responses in a veteran population, indicated a study population of 138 patients should detect a reduction in Double Product response to mental stress following psychological intervention, with over 90% power, assuming 20% drop-out rate.p-value: 0.18ANOVA
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.
Time frame: 3 months post intervention
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavioral Stress Management | Mental Stress Induced Elevation in Double Product by Math Stress Task | Pre intervention | 1915 mmHg x beats/minute | Standard Error 263 |
| Cognitive Behavioral Stress Management | Mental Stress Induced Elevation in Double Product by Math Stress Task | 3 months post intervention | 1399 mmHg x beats/minute | Standard Error 201 |
p-value: 0.025ANCOVA
Secondary
Cardioverter-DefibrillatorTherapies
Cardioverter-Defibrillator therapies for treatment of serious ventricular arrhythmia
Time frame: 6 months post intervention
Population: Cardioverter-defibrillator interrogation data between 3 and 6 months post intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cognitive Behavioral Stress Management | Cardioverter-DefibrillatorTherapies | 0 percentage of participants |
| Patient Education | Cardioverter-DefibrillatorTherapies | 6 percentage of participants |
p-value: 0.21Fisher Exact
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..
Time frame: 3 months post intervention
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Stress Management | Depression/Dejection | 20 units on a scale | Standard Deviation 6 |
| Patient Education | Depression/Dejection | 24 units on a scale | Standard Deviation 11 |
p-value: 0.048ANOVA
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.
Time frame: 6 months post intervention
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Stress Management | High Frequency Heart Rate Variability | 41 percentage of spectral power | Standard Deviation 19 |
| Patient Education | High Frequency Heart Rate Variability | 26 percentage of spectral power | Standard Deviation 16 |
p-value: 0.01ANOVA
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.
Time frame: 6 months post intervention
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Stress Management | Low Frequency Heart Rate Variability | 59 percentage of spectral power | Standard Deviation 19 |
| Patient Education | Low Frequency Heart Rate Variability | 70 percentage of spectral power | Standard Deviation 21 |
p-value: 0.01ANOVA
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.
Time frame: 6 months post intervention
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Stress Management | Low Frequency/High Frequency Ratio of Heart Rate Variability | 1.99 Ratio | Standard Deviation 1.47 |
| Patient Education | Low Frequency/High Frequency Ratio of Heart Rate Variability | 4.01 Ratio | Standard Deviation 3.26 |
p-value: 0.01ANOVA
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..
Time frame: Immediate post intervention
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Stress Management | Perceived Stress | 10 units on a scale | Standard Deviation 6 |
| Patient Education | Perceived Stress | 14 units on a scale | Standard Deviation 8 |
p-value: 0.011ANOVA
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..
Time frame: Immediate post intervention
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Stress Management | State Anger | 16 units on a scale | Standard Deviation 2 |
| Patient Education | State Anger | 19 units on a scale | Standard Deviation 7 |
p-value: 0.02ANOVA
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..
Time frame: Immediate post intervention
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Stress Management | Tension/Anxiety | 8 units on a scale | Standard Deviation 4 |
| Patient Education | Tension/Anxiety | 12 units on a scale | Standard Deviation 7 |
p-value: 0.003ANOVA