A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Congenital Heart Disease: WE BEAT CHD Study

Summary

The goal of this pragmatic clinical trial is to learn if the WE BEAT program, a 5-week group-based online wellbeing and skill-building program, can help teens with congenital heart disease (CHD) improve their ability to handle stress. The main question it aims to answer is if participants who receive the WE BEAT program become more resilient (the ability to bounce back from from tough times or recover from something difficult) and have better quality of life compared to participants who receive usual care. The study also aims to learn if there are connections between participant-reported psychosocial data (such as resilience, feelings about one's life and one's physical, mental, and social wellbeing) and clinical outcomes.

Eligible participants who are 12-17-year-old will be in the study for about 6 months and be randomized to receive either the WE BEAT program or usual care. Following completion of the primary WE BEAT intervention at Week 5, intervention arm participants will be randomized to a single-session booster session (occurring at Week 18) vs no booster session. The booster session will be provided in a similar format to the WE BEAT program. A review of all modules/skills introduced in the program will be provided.

All participants will complete 4 sets of online surveys and give 3 hair/saliva samples at different timepoints. Some participants may volunteer to give optional blood and urine samples.

Conditions

• Patient-Reported Outcome Measures (PROMs)
• Pragmatic Trial
• Adolescent Congenital Heart Disease
• Resiliency-building Intervention
• Resilience, Psychological
• Telemedicine-Based Education

Interventions

BEHAVIORAL

Telemedicine-based resiliency-building intervention

Improving Access and Increasing Resilience through the WE BEAT Well-Being Education Program. The WE BEAT Well-Being Education Program was developed for pediatric patients with heart disease. The evidence-based components of the 5-module WE BEAT intervention are derived from cognitive behavioral theory, stress management and resiliency research, and behavioral intervention science across pediatric populations and adult heart disease. The five WE BEAT modules include: Well-being Education--Introduction, Breathe--Mindfulness and Relaxation-Based Skills, Energize--Positive Psychology Skills, Adjust--Cognitive Skills Training, and Thanks--Gratitude Practice. The objective is to foster positive psychological well-being and resilient outcomes in adolescents with CHD through a mental health promotion and prevention while providing access to safe, peer-to-peer community building. Through its group-based telemedicine delivery, the program aims to increase access to mental health care.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Carelon Research

  lead OTHER

Principal Investigators

• Melissa Cousino, PhD · University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-20

Primary Completion

2029-04-30

Completion

2029-06-30

Countries

• United States

Study Locations