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New tablet tool aims to ease emotional burden for ICU Decision-Makers

NCT ID NCT07630844

Symptom relief Sponsor: Case Western Reserve University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests REFRAME, a short tablet-based program designed to help family members manage overwhelming emotions when making medical decisions for critically ill loved ones in the ICU. About 387 participants will be randomly assigned to either REFRAME or an informational support program. The goal is to see if REFRAME reduces depressive symptoms and improves emotional regulation, potentially leading to a widely available tool for families in crisis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
REFRAME (a tablet-based emotion regulation program)
What this could lead to
If it works, this could provide a simple, widely accessible tool to reduce emotional suffering and improve medical decision-making for families in crisis.
What could go wrong
This is an early-stage behavioral trial with no drug involved, so the effect may be small or not generalizable. Results depend on participants' engagement and may not apply to all settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 387 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Apr 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Critical Illness Emotional Regulation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Critical illness

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

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