Positive Psychotherapy to Improve Autonomic Function and Mood in ICD Patients (PAM-ICD): Rationale and Design of an RCT Currently Underway

Background Improving mental and physical health of patients with implantable cardioverter defibrillators (ICD) is critical because this group is at high risk for ventricular arrhythmias and sudden death and depressed or anxious cardiovascular disease (CVD) patients appear to be at even higher risk for mortality compared to nondepressed or nonanxious CVD patients. Further, autonomic dysfunction is present in these patients, and negative emotions and arrhythmias form a downward spiral further worsening mood, well‐being, and cardiovascular health. Much research demonstrates that positive emotion is related to health benefits, improved physiology, and increased survival. Methods and Results This is a two‐arm randomized controlled trial aiming to recruit 60 adult ICD patients comparing 12 individually delivered, weekly sessions of: (1) a positive emotion‐focused cognitive‐behavioral therapy (Quality of Life Therapy [QOLT]), and (2) Heart Healthy Education. Autonomic functioning, heart rhythm indices, and psychosocial health are measured at baseline, 3 months, and 9 months. The first goal is feasibility and acceptability, with the primary outcome being arrhythmic event frequency data. Conclusion This study is designed to test whether QOLT produces changes in mood, quality of life/well‐being, autonomic function, and arrhythmic and ICD therapy event rates. This feasibility trial is a foundational step for the next trial of QOLT to help determine whether a 3‐month QOLT trial can reduce arrhythmias occurrences among ICD patients, and examine a mechanism of autonomic functioning. This study may help to develop and implement new medical or psychological therapies for ICD patients.