Healing together: could a Couples-Based program ease ICU aftermath?

NCT ID NCT07778004

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This study tests a program called ICU-SUCCEED, designed to help survivors of acute respiratory failure and their family caregivers cope and manage recovery together. The program includes one in-person session and four follow-up sessions by phone or video, focusing on communication, stress management, and lifestyle. The trial aims to see if this approach is feasible and acceptable, and whether it can reduce anxiety and depression in patients after a critical illness.

What this could mean

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

Active substance
A behavioral intervention called ICU-SUCCEED, involving sessions on communication, self-management, and stress management for patients and their caregivers.
What this could lead to
If successful, this program could offer a practical way to support recovery and reduce anxiety and depression in ICU survivors and their families.
What could go wrong
This is a small pilot study focused on feasibility, so it may not show clear benefits. The intervention requires time and commitment from both patients and caregivers.

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 144 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2030

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 to 99 years

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 * Admitted to the medical ICU at UNC with acute respiratory failure (functional lung impairment resulting in hypoxia, hypercapnia, or both) and/or sepsis with significant end organ dysfunction. * At least 18 years old * Survives to hospital discharge * Is expected to be discharged home or to an acute inpatient rehabilitation center with a clear plan to be subsequently discharged home * Capable of providing written informed consent * Has English language proficiency Caregiver Inclusion Criteria * Provides emotional, physical, and/or financial support to the patient in a non-professional, unpaid capacity * Must be related to the patient in one of the following ways: a spouse or domestic partner, an adult child, a parent, or a sibling * At least 18 years of age * Has English language proficiency * Must be the caregiver of a patient that meets the patient eligibility criteria listed above Patient Exclusion Criteria: * No available family caregiver * Lacks decision-making capacity * Under 18 years of age * Living at a location other than home prior to admission * Unhoused prior to admission * Receives extracorporeal membrane oxygenation (ECMO) during hospital stay * Expected to discharge to any location other than home or an acute inpatient rehabilitation center * Does not have English language proficiency Caregiver Exclusion Criteria * Does not provide emotional, physical, and/or financial support to the patient in a non-profession, unpaid capacity * Is not related to the patient in one of the following ways: a spouse or domestic partner, an adult child, a parent, or a sibling * Cannot complete surveys or engage in other study activities due to physical or cognitive limitations * Unhoused prior to admission * Is under 18 years of age * Does not have English language proficiency * Is not the caregiver of a patient that meets the patient eligibility criteria listed above

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  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

  • UNC Hospitals

    Chapel Hill, North Carolina, 27599, United States

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