Stress Reduction Program to Reduce Abnormal Heart Rhythms Treated With Implantable Cardioverter Defibrillators (The RISTA Study) (RISTA)
Recruitment status was: Recruiting
|Arrhythmias, Cardiac||Behavioral: Stress reduction treatment (SRT) program||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Reducing Vulnerability to ICD Shock Treated Ventricular Arrhythmias|
- ICD shock-treated ventricular arrhythmia event-free survival [ Time Frame: Measured at Month 24 ]
- Laboratory stress-provoked arrhythmogenic changes in the heart rhythm [ Time Frame: Measured at Baseline and Month 6 ]
- 24-hour heart rate variability [ Time Frame: Measured at Baseline and Month 6 ]
- Quality of life [ Time Frame: Measured at Month 24 ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
No Intervention: 1
Participants will receive the usual cardiologic care for ICD patients provided by their medical team.
In addition to the usual cardiologic care for ICD patients provided by the participants medical team, those randomized to Intervention will receive the stress reduction treatment (SRT) program (see below).
Behavioral: Stress reduction treatment (SRT) program
The SRT program is a cognitive behavioral program that consists of 8 group sessions over a period of 10 weeks.
An ICD is a device designed to quickly detect a life-threatening, rapid heartbeat. Through a process called defibrillation, the ICD tries to convert an abnormal heart rhythm back to normal by delivering an electrical shock to the heart. The ICD continuously monitors heartbeats to ensure that they are normal, and it only delivers a shock to the heart when it senses a life-threatening arrhythmia. Because of the recent funding approval by Medicaid, it is now estimated that more than 500,000 people will receive ICDs annually. Although ICDs are life-saving medical devices, some people may experience anxiety, depression, and impaired quality of life as a result of the repeated ICD shocks. Additionally, increased mental and emotional stress and anger may increase the likelihood of experiencing more arrhythmias requiring an ICD shock. SRT programs that encourage people to manage their emotions may decrease the frequency of arrhythmias. Furthermore, SRT programs have been shown to be successful at reducing other stress-related heart conditions. The purpose of this study is to evaluate the effectiveness of an SRT program at reducing the incidence of ICD shock-treated arrhythmias among people with newly implanted ICDs.
This study will enroll people who have recently received an ICD. Initially, participants will complete questionnaires about mood and attitudes. Next, at a baseline study visit, participants will complete a mental stress exercise in which they will perform math problems and describe an experience that made them angry. During this exercise, participants will undergo blood pressure measurements, blood collection, and an electrocardiogram (EKG) to measure electrical activity of the heart. Participants will also wear a monitor for 24 hours after the study visit to record heart activity. Participants will then be randomly assigned to either take part in the SRT group and receive usual care or only receive usual care. For 10 weeks, participants in the SRT group will attend 8 group sessions that will focus on learning and applying stress reduction techniques to everyday living. All participants will attend a 3-month follow-up visit for repeat baseline testing. At Months 6, 12, and 24, participants will complete questionnaires during routine doctor's visits or by mail.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00627263
|Contact: Matthew M. Burg, PhDemail@example.com|
|Contact: Joanne McGloinfirstname.lastname@example.org|
|United States, Connecticut|
|Yale University Medical School||Recruiting|
|New Haven, Connecticut, United States, 06520|
|Principal Investigator: Matthew M. Burg, PhD|
|Sub-Investigator: Rachel Lampert, MD|
|Principal Investigator:||Matthew M. Burg, PhD||Yale University|