Rationale and design of a randomized controlled clinical trial of a resilience-building intervention in adults with congenital heart disease

Contemp Clin Trials. 2024 Oct:145:107638. doi: 10.1016/j.cct.2024.107638. Epub 2024 Jul 22.

Abstract

Background: Adults with congenital heart disease (ACHD) are at risk for lower quality of life (QOL) and psychological health. Behavioral interventions to meet their psychosocial needs are lacking. The aim of this study is to evaluate the feasibility of implementing the Promoting Resilience in Stress Management (PRISM) intervention in ACHD and its efficacy in increasing resilience in this population.

Methods: We designed a phase II randomized controlled clinical trial of patients with moderate or complex ACHD, physiological stages C or D. Enrolled participants will be randomized to receive PRISM or usual care. PRISM is a manualized, skills-based behavioral intervention comprised of four one-on-one sessions targeting resilience resources (stress-management, goal-setting, cognitive reframing, meaning making), an optional session on advance care planning, and a facilitated family meeting. Participants in both groups will complete study questionnaires at enrollment and 3-months later. The primary aim is to describe feasibility, namely the proportions of patients who a) enroll in the study among those eligible, and b) complete the PRISM intervention among those randomized to that arm. We will also evaluate PRISM's efficacy by using linear regression models to compare changes in mean resilience scores between assigned groups. In exploratory analyses, we will evaluate effects on QOL, psychological distress, perceived competence for health care management, and comfort with advance care planning.

Discussion: This study will provide rigorous evidence to determine the feasibility and efficacy of a brief intervention to promote resilience and psychosocial health in ACHD. Findings may guide the development of a future multi-site effectiveness study.

Clinical trial registration: NCT04738474.

Keywords: Behavioral intervention; Clinical trial; Congenital heart disease; Quality of life; Resilience.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adult
  • Advance Care Planning / organization & administration
  • Clinical Trials, Phase II as Topic
  • Cognitive Behavioral Therapy / methods
  • Feasibility Studies
  • Female
  • Goals
  • Heart Defects, Congenital* / psychology
  • Heart Defects, Congenital* / therapy
  • Humans
  • Male
  • Psychosocial Intervention / methods
  • Quality of Life*
  • Randomized Controlled Trials as Topic
  • Research Design
  • Resilience, Psychological*
  • Stress, Psychological / therapy

Associated data

  • ClinicalTrials.gov/NCT04738474