Exploring cardiac-related PTSD symptoms in patients with implantable cardioverter defibrillators: protocol for an open-label trial of written exposure therapy and qualitative study

<b>Introduction:</b> Posttraumatic stress disorder (PTSD) symptoms develop in approximately 20% of individuals following a sudden, life-threatening cardiac arrhythmia and subsequent implantable cardioverter defibrillator (ICD) implantation. ICD-related PTSD symptoms are not only common but associated with adverse disease outcomes, and yet studies examining psychological treatments for these medically induced symptoms are rare. Written Exposure Therapy (WET) is a brief and efficacious trauma-focused intervention for PTSD, but it has yet to be evaluated in individuals who developed PTSD symptoms following a cardiac event.<b>Objective:</b> This paper describes the design and procedures of a multi-method study exploring individuals' ICD-related PTSD symptom manifestations and responses to WET. The study will begin with a qualitative examination of participants' experiences with medically induced PTSD symptoms and their perceptions of WET. Next, we will conduct a single-arm open-label trial to evaluate the feasibility, acceptability, and preliminary efficacy of WET for individuals with ICD-related PTSD symptoms.<b>Methods:</b> Adults with elevated ICD-related PTSD symptoms (N = 15) will first complete a semi-structured interview querying participants' experiences with medically induced PTSD symptoms, perceptions of WET, and barriers and facilitators to treatment engagement. They will then complete five weekly sessions of WET. A brief exit interview will be conducted to assess the acceptability of the WET intervention and changes in PTSD symptoms experienced by participants. Primary outcomes of the trial include feasibility (recruitment, retention, adherence) and acceptability (credibility, expectancy, and satisfaction ratings and qualitative interviews). Secondary outcomes include changes in total and fear-related PTSD symptoms, ICD-related fear, and health-related quality of life assessed pre-, during, and post-treatment and at a 1-month follow-up.<b>Conclusions:</b> This study will provide initial evidence of the feasibility, acceptability, and potential utility of WET for ICD-related PTSD symptoms. Results will inform future randomized controlled trials and guide clinical implementation efforts for those with medically induced PTSD.