New therapy aims to ease grief and PTSD for families of ICU patients
NCT ID NCT05587517
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a short therapy program called EMPOWER for family members who make decisions for critically ill patients in the ICU. The therapy includes breathing exercises, mindfulness, and coping techniques delivered by a mental health professional. Researchers will compare it to supportive conversation to see if it reduces grief, PTSD, and depression over a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- EMPOWER (a behavioral therapy combining cognitive behavioral and acceptance and commitment techniques)
- What this could lead to
- If it works, this could provide an effective, brief therapy to help family surrogates cope with grief and trauma after a loved one's critical illness.
- What could go wrong
- This is a Phase 2 trial with only 172 participants, so results may not apply to everyone. The therapy is new and may not reduce symptoms more than supportive conversation.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 172 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2022
- Expected to finish
-
Dec 2027
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
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
Inclusion Criteria: * Patients who, during their hospital stay, have been admitted to the ICU and are near EoL, as indicated by a modified "surprise question" whereby physicians are asked to identify patients whom they do not expect to survive the next 12 months. * Surrogate decision-makers of patients who were admitted to the ICU or step-down unit during their current admission/stay, or within 1 month of discharge from their last admission/stay. * Surrogate decision-makers are 18 years or older. * Surrogate decision-makers whom physicians or advance practice providers (i.e. physician assistants, nurse practitioners) indicate as the designated health care proxy or decision-making patient surrogates, or who are listed as such in the patient's medical charts or by self-report of the surrogate. * Surrogate decision-makers must speak English. * Surrogate decision-makers must report "syndromal" levels of pre-loss grief (PG-12 score ≥ 25) or peritraumatic distress (PDI ≥ 23). * Surrogate decision makers will need to reside in a state in which an interventionist is licensed or otherwise be able to comply with current telehealth regulations. * Surrogate decision-makers will need to be willing to utilize a device (computer, tablet, phone) with internet. * Surrogate decision-makers who are able and willing to provide an emergency contact. Exclusion Criteria: * Patients and surrogate decision-makers who do not meet the eligibility criteria. * Surrogate decision-makers who indicate the presence of cognitive impairment based on responses to the Ultra-Brief Confusion Assessment Method and/or significant psychiatric or cognitive disturbance sufficient, in the investigator/study staff's judgment, to preclude completion of the assessment measures, interview or informed consent. * Surrogate-decision makers who endorse suicidal ideation in the past month based on responses to the Columbia Suicide Severity Rating Scale. * Surrogate-decision makers who are unable to access a functional device for videoconferencing and decline the offer to use a study loner device.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Critical care are added.
Genom att skicka in godkänner du våra Användarvillkor
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
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
3 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10021, United States
-
NewYork-Presbyterian Weill Cornell Medicine
RECRUITINGNew York, New York, 10065, United States
-
University of Miami
NOT_YET_RECRUITINGMiami, Florida, 33136, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- What makes a hospital Low-Resource? global panel seeks a common answer
- Fixing broken ribs with surgery may cut pain better than drugs alone
- Ultrasound under the collarbone may help doctors decide who needs IV fluids after trauma
- Which injury score better predicts survival? researchers put two tools to the test
- Can Real-Time heart monitoring during trauma surgery save lives?
- Can laughter yoga and art therapy on a phone app heal earthquake trauma?