REFRAME: an Emotion Regulation Intervention to Improve Psychological Outcomes in Surrogate Decisi… (NCT07630844) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
REFRAME: an Emotion Regulation Intervention to Improve Psychological Outcomes in Surrogate Decision-Makers of the Critically Ill
United States387 participantsStarted 2027-01-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Patient Inclusion Criteria:
* 1\. Age ≥ 35 years
* 2\. Lacks decision-making capacity
* 3\. Not expected to be discharged from the ICU in 24 hours (including death)
Legally Authorized Representative Inclusion Criteria (Primary Participant)
* 1\. Age ≥ 18 years
* 2\. Identified as LAR by ICU team
* 3\. Able to speak and understand English
* 4\. Able to visualize content on a tablet device
Patient Exclusion Criteria:
* 1\. Age \< 35 years
* 2\. Possesses decision-making capacity
* 3\. Anticipated discharge from ICU within next 24 hours.
Legally Authorized Representative Exclusion Criteria:
* 1\. Age \< 18 years
* 2\. Not recognized as LAR by ICU team
* 3\. Unable to speak and understand English
* 4\. Unable to visualize content on a tablet device
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in depressive symptoms as measured by PROMIS Emotional Distress-Depression Short Form
Timeframe: Baseline, 5-7 days post-baseline, and 90-days post-baseline.