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NOT YET RECRUITING
NCT07630844
NA

REFRAME: an Emotion Regulation Intervention to Improve Psychological Outcomes in Surrogate Decision-Makers of the Critically Ill

Sponsor: Case Western Reserve University

View on ClinicalTrials.gov

Summary

Every year in the United States, millions of adults make crucial medical decisions for loved ones in the intensive care unit while facing extreme emotional stress. This project will assess REFRAME, a brief tablet-based program designed to help decision-makers manage their emotions in these situations. Results from this study may lead to the creation of a widely accessible tool that alleviates emotional suffering and enhances the quality of medical decision-making for families in crisis.

Official title: A Randomized Trial of REFRAME: an Emotion Regulation Intervention to Improve Psychological Outcomes in Surrogate Decision-Makers of the Critically Ill

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

387

Start Date

2027-01-04

Completion Date

2031-04-04

Last Updated

2026-06-25

Healthy Volunteers

No

Interventions

BEHAVIORAL

REFRAME

consists of three self-guided, tablet-based modules that align with the process model of emotion regulation. Each module lasts approximately 10-20 minutes and is delivered sequentially over three sessions, spaced 24-48 hours apart after enrollment.

BEHAVIORAL

Informational Support

The informational support (IS) condition functions as an attention-matched psychoeducational control, featuring three sequential video-based modules delivered every 24-48 hours.

Locations (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States