Mental Stress Reduction in Defibrillator Patients

Effectiveness of Mental Stress Reduction in Defibrillator Patients

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

Study Overview

• Status: Terminated
• Conditions: Anger; Stress; Arrhythmia; Cardiomyopathy, Dilated
• Intervention / Treatment: Behavioral: Cognitive Behavioral Stress Management (CBSM); Other: Patient Education

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 Type: Interventional
• Enrollment (Actual): 129
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Wlliam S. Middleton Memorial Veterans Hospital, Madison
    • Milwaukee, Wisconsin, United States, 53295-1000
      • Zablocki VA Medical Center, Milwaukee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Investigators: Principal Investigator: Douglas Russell, MD PhD, Wlliam S. Middleton Memorial Veterans Hospital, Madison

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: February 14, 2008
• First Submitted That Met QC Criteria: February 15, 2008
• First Posted (Estimate): February 27, 2008

Study Record Updates

• Last Update Posted (Estimate): December 22, 2014
• Last Update Submitted That Met QC Criteria: December 15, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Defibrillators, Implantable; Anger; Stress, Psychological; Cognitive Therapy; Tachycardia, Ventricular; Death, Sudden Cardiac
• Additional Relevant MeSH Terms: Behavioral Symptoms; Heart Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Cardiomegaly; Laminopathies; Stress, Psychological; Cardiomyopathies; Cardiomyopathy, Dilated
• Other Study ID Numbers: CLIN-008-07F