Effectiveness of Mental Stress Reduction in Defibrillator Patients
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Enrollment
- 129
- Locations
- 2
- Primary Endpoint
- Mental Stress Induced Elevation in "Double Product" by Math Stress Task
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Cognitive Behavioral Stress Management
10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions
Intervention: Cognitive Behavioral Stress Management (CBSM) (Behavioral)
Patient Education
10 week program of once weekly Patient Education group sessions
Intervention: Patient Education (Other)
Outcomes
Primary Outcomes
Mental Stress Induced Elevation in "Double Product" by Math Stress Task
Time Frame: 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 Math Stress Task
Time Frame: 3 months post intervention
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
Time Frame: 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 Outcomes
- State Anger(Immediate post intervention)
- Tension/Anxiety(Immediate post intervention)
- Perceived Stress(Immediate post intervention)
- Depression/Dejection(3 months post intervention)
- Low Frequency Heart Rate Variability(6 months post intervention)
- High Frequency Heart Rate Variability(6 months post intervention)
- Low Frequency/High Frequency Ratio of Heart Rate Variability(6 months post intervention)
- Cardioverter-DefibrillatorTherapies(6 months post intervention)