Mental Stress Reduction in Defibrillator Patients

NCT00624520 | Terminated Phase 3 Results DMC

• 1 other identifier: CLIN-008-07F
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 2

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

Conditions

Cardiomyopathy, Dilated; Arrhythmia; Anger; Stress

Keywords

Stress, Psychological; Tachycardia, Ventricular; Defibrillators, Implantable; Death, Sudden Cardiac; Cognitive Therapy; Anger

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• 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

Study Arms (2)

Cognitive Behavioral Stress Management

ACTIVE COMPARATOR

10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions

Behavioral: Cognitive Behavioral Stress Management (CBSM)

Patient Education

ACTIVE COMPARATOR

10 week program of once weekly Patient Education group sessions

Other: Patient Education

Interventions

Cognitive Behavioral Stress Management (CBSM) BEHAVIORAL

10 week program of weekly CBSM therapy group sessions

Cognitive Behavioral Stress Management

Patient Education OTHER

10 week program of "Patient Education" group sessions, involving presentations of educational materials relating to heart disease.

Patient Education

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>21 years,
• ICD Implantation,
• \> 3 months following ICD implantation,
• willingness to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (2)

Wlliam S. Middleton Memorial Veterans Hospital, Madison

Madison, Wisconsin, 53705, United States

Location

Zablocki VA Medical Center, Milwaukee

Milwaukee, Wisconsin, 53295-1000, United States

Location

Related Publications (1)

• 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.

  PMID: 26010524 DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Arrhythmias, Cardiac; Stress, Psychological; Tachycardia, Ventricular; Death, Sudden, Cardiac

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Tachycardia; Cardiac Conduction System Disease; Heart Arrest; Death, Sudden; Death

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr Douglas C Russell
• Organization: Department of Veterans Affairs

Dcrussel@facstaff.wisc.edu

608-256-1901

Study Officials

• Douglas Russell, MD PhD

  Wlliam S. Middleton Memorial Veterans Hospital, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 27, 2008
• Study Start: September 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2014
• Last Updated: December 22, 2014
• Results First Posted: December 22, 2014

Record last verified: 2014-12

Locations

US (2)