Rationale and Design of a Randomized Clinical Trial Comparing Stress Reduction Treatment to Usual Cardiac Care: The Reducing Vulnerability to Implantable Cardioverter Defibrillator Shock-Treated Ventricular Arrhythmias (RISTA) Trial

Abstract

Objective-Present the design of a multicenter randomized trial testing the effects of Stress Reduction Treatment (SRT) on the prevalence of shock treated ventricular arrhythmias among patients with an implantable cardioverter defibrillator (ICD). Significant adjustment problems secondary to ICD shock can increase the likelihood of arrhythmias requiring shock for termination. Whether SRT can reduce arrhythmias requiring shock for termination in patients with ICDs has not been tested in clinical trials.Methods-New ICD recipients and previous recipients who have received an appropriate therapeutic shock in the past 6 months (n=304) will be enrolled and randomized to either SRT or usual cardiac care. Participants complete a psychosocial questionnaire and undergo laboratory mental stress testing and 24-hour holter monitoring with diary at study entry and approximately 4 months later. Follow-ups are completed at 6-, 12-, and 24-months post randomization to assess occurrence of ICD shock for ventricular arrhythmias (primary outcome), ATP events, medication changes, hospitalizations, deaths, and quality of life.Results-Log-rank test and Cox proportional hazards model will be used to test the effects of SRT on time to first shock treated ventricular arrhythmia, with exploratory analyses testing the effects on overall frequency of ventricular arrhythmia. Secondary analyses will test the effects of SRT on lab stress induced and 24-hour arrhythmogenic electrophysiological indices from pre-to post-treatment, and both quality of life and measures of anger across the 2-years of the study.Conclusions-The RISTA Trial is the first large scale randomized clinical trial designed to evaluate the effect of SRT on the prevalence of shock-treated arrhythmias among patients with an ICD. Results may demonstrate a treatment that can reduce vulnerability to arrhythmia provoked shock and improve quality of life.Correspondence: Matthew M. Burg, Ph.D., Yale University School of Medicine, Internal Medicine-Cardiology, 333 Cedar Street, FMP 3, New Haven, Connecticut 06520; Phone 203-937-3882; Fax 203-937-3884; mb2358@columbia.edu.. RISTA is registered at ClinicalTrials.gov: NCT00627263 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. (2) or induced (3) life-threatening ventricular arrhythmias -the original targets of this therapy -but also for primary prevention in patients with impaired left ventricular (LV) function due to either ischemic or non-ischemic cardiomyopathies accompanied by congestive heart failure (4-6). These trials have led to expansions of the initial indications for ICD therapy, and with the recent...

A Randomized Controlled Trial of Cognitive Behavior Therapy Tailored to Psychological Adaptation to an Implantable Cardioverter Defibrillator

“…Although these studies, taken together, suggest that CBT is not associated with reduced arrhythmia events, it is important to note that arrhythmia events were defined as those triggering an ICD therapy, and thus, arrhythmia events below the treatment threshold would be missed. Studies to better address arrhythmia outcomes of CBT are underway (5).…”

“…Elevated depressive and anxiety symptoms (2)(3)(4), in turn, are associated with an increased risk of arrhythmia events necessitating ICD therapies. The high occurrence rate of psychological problems and the potential detrimental effects on cardiac function underscore the need for psychosocial interventions that can help individuals optimize adaptation to the ICD and possibly prevent emotionally triggered ventricular arrhythmias necessitating ICD shock therapy (5).…”

Psychological vulnerability, ventricular tachyarrhythmias and mortality in implantable cardioverter defibrillator patients: is there a link?

“…Even though some of these trials are plagued by methodological short comings, they show that multifactorial interventions are likely to be the most successful, including for example cognitive behavioral therapy, psycho-education about the ICD and cardiac rehabilitation as some of the mainstay components [85], which can, if warranted, be combined with pharmacological treatment. Other trials with the aim to improve mental health outcomes in ICD patients are currently underway that use comprehensive and state-of-the-art techniques in behavioral medicine, including e-health [86,87]. …”

Managing With Pacemakers and Implantable Cardioverter Defibrillators

“…The largest study to date of a stress reduction therapy is ongoing, using a cognitive-behavioral model of stress that emphasizes the interactive relationship of cognition, emotion, physiology, and behavior (Reducing Vulnerability to ICD Shock Treated Arrhythmia [RISTA]). 21 Whether interventions should be offered to all ICD patients, or are of most benefit in subgroups demonstrating distress at baseline, is an important avenue of future research.…”

“…One small study (N=70) found a positive effect of cognitive therapy on ICD-treated ventricular arrhythmias at 3 months. 31 The larger ongoing RISTA study described above 21 is powered to investigate the effects of a stress management intervention on receipt of appropriate ICD therapy as a primary end point.…”