In this interview we speak with Matthew M. Burg, PhD, Associate Clinical Professor of Medicine at Yale University School of Medicine. Dr. Burg is the Principal Investigator of the Reducing Vulnerability to ICD Shock Treated Ventricular Arrhythmias (RISTA) Study, a randomized, single-blind trial currently underway.

What prompted the RISTA study? What is the purpose of the RISTA study?
In our previous research, we found that engaging in cognitively stressful tasks or describing a previous event that provoked anger, resulted in electrophysiological effects of a pro-arrhythmic nature among patients with implantable cardioverter defibrillators (ICDs). Furthermore, we found that the experience of moderate to extreme anger during routine daily activities increased the risk of an arrhythmia requiring shock for termination in this group. Thus, the purpose of the RISTA Trial is to determine whether teaching ICD patients how to manage/reduce routine stress: 1) reduces the likelihood of them having an arrhythmia requiring shock for termination; 2) limits the electrophysiological effects of stress; and 3) improves quality of life.

How many patients and clinical sites are participating in the trial?
We plan on enrolling 304 patients at 3 sites — Yale affiliated hospitals, Hartford Hospital, and Columbia University Medical Center.

Tell us about the aspects of the stress reduction treatment (SRT) program.
The stress reduction treatment is delivered in a group context, with eight 1½ hour sessions conducted over a 10-week period. At each session we cover a different aspect of stress reduction methods, including: 1) a focus on the automatic thoughts that arise during stress and give rise to strong emotions, and how to re-direct these automatic thoughts in a more useful direction so as to gain control over negative emotions; 2) how to use communication more effectively to reduce stress in social and work situations; 3) how to use standard and structured problem solving approaches to respond more effectively to the demands of each day; 4) how to distinguish important activities from compelling activities and how to use commitment-driven goals to gain greater control over the day; 5) how to use a range of physical relaxation strategies (e.g., progressive muscle relaxation, diaphragmatic breathing, visualization) throughout the day to keep stress from getting out of hand.

Are similar SRT programs in place elsewhere? How have similar SRT programs been successful in other areas of cardiology?
The approach we are using in RISTA is standard for stress reduction training and broadly follows the cognitive behavioral stress management strategies that are widely utilized in both practice and research. Similar protocols have been used in the group part of the intervention used for the ENRICHD (Enhancing Recovery in Coronary Heart Disease Patients) clinical trial with depressed post-ACS patients, and by Blumenthal et al in their clinical trial of treatment for patients with mental stress-provoked ischemia.

How will participants be tested?
The primary outcome for the study is incidence of ICD activity (shock, pacing) for ventricular arrhythmias. Secondary outcomes include the electrophysiological response during performance of stressful tasks in the laboratory, and quality of life (e.g., depression, anxiety, anger, coping) assessed on a psychosocial questionnaire at study entry and every several months over the two-year period of study participation.