Abstract
BACKGROUND: Interventions are needed to address growing concerns regarding poor psychosocial and mental health in adult congenital heart disease (ACHD). Strengthening patients' resilience is one proposed pathway, given its ability to improve quality of life in other patient populations. OBJECTIVES: The objective of this study was to evaluate feasibility and efficacy of a resilience-building intervention in ACHD. METHODS: We conducted a clinical trial of outpatients with moderate or complex ACHD, randomized to receive a cognitive-behavioral intervention (Promoting Resilience in Stress Management [PRISM]) vs usual care. Participants completed surveys at randomization and 3 months. We evaluated feasibility using enrollment and retention rates. We evaluated PRISM's effect on the primary outcome (change in self-reported resilience) and exploratory outcomes using linear regression adjusted for baseline measurement. RESULTS: We enrolled 78 patients from March 2023 to April 2024. Patients were randomized to treatment (PRISM; n = 40, age 36 ± 11 years; 50% female; 58% self-reported White race/ethnicity) vs control (n = 38, age 40 ± 12 years; 74% female; 79% White). Over three-quarters of participants randomized to treatment completed PRISM (80%) and follow-up measures. Of controls, 35/38 (92%) completed follow-up measures. Resilience scores at 3 months were higher in the treatment group (n = 30, 30.1 ± 8.1) compared to control (n = 35, 28.7 ± 5.8); this difference was not statistically significant. Mean quality of life at follow-up was significantly higher in the treatment group (79 ± 14 vs 73 ± 14; 95% CI: 0.8-12.7; P = 0.03). Program feedback was positive. CONCLUSIONS: This study demonstrates intervention feasibility with modifications. Although we did not demonstrate efficacy, participants were engaged and provided valuable feedback, suggesting value in ACHD. (Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease [PRISMACHD]; NCT04738474).