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The purpose of this study is to evaluate the feasibility and preliminary efficacy of the Promoting Resilience in Stress Management (PRISM) intervention in patients with adult congenital heart disease.
After consent is obtained, eligible patients (moderate or complex ACHD, stages B, C, or D) will complete the baseline study measures assessment and be randomized to receive PRISM or usual care (anticipated n=86, 43 per group). Patients in the intervention group will participate in the six PRISM sessions over 3 months. At 3 months following enrollment, patients in both groups will again complete study measures. We will define feasibility as a) the proportion of eligible patients who enroll and b) the proportion of patients who complete the intervention among those randomized to intervention. We will define preliminary efficacy as the change in mean resilience from baseline to 3 months after randomization between those randomized to intervention and usual care. Exploratory analyses will examine PRISM's impact on patient-centered outcomes of quality of life, symptoms of anxiety and depression, and perceived competence for health care.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Washington
Seattle, Washington, United States
Start Date
March 15, 2023
Primary Completion Date
July 25, 2024
Completion Date
July 25, 2024
Last Updated
December 15, 2025
78
ACTUAL participants
Promoting Resilience in Stress Management (PRISM)
BEHAVIORAL
Usual Care
OTHER
Lead Sponsor
University of Washington
Collaborators
NCT05647213
NCT07042334
Data Source & Attribution
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