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Support for Families of Critically Ill Patients

This study is testing two ways to help family members who are making difficult decisions for critically ill loved ones in the Intensive Care Unit (ICU). These family members, called surrogates, often experience significant grief and stress. The study compares a program called EMPOWER, which uses techniques from cognitive behavioral therapy and acceptance and commitment therapy, with a Supportive Conversation. EMPOWER involves breathing exercises, mindfulness, and talking about the patient. The Supportive Conversation offers similar time and attention. The goal is to see if EMPOWER can reduce symptoms of prolonged grief, post-traumatic stress disorder (PTSD), and anticipatory grief over 12 months, compared to the Supportive Conversation. This study is for adults aged 18 and older who are surrogate decision-makers for patients near the end of life in the ICU.

Study design
This is an interventional study with a planned enrollment of 172 participants. It compares two different interventions: EMPOWER and Supportive Conversation.
What's involved
The EMPOWER intervention and the Supportive Conversation will each last about 1.5-2 hours, with two additional follow-up calls.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the start of the study through twelve-month follow-up.

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NCT05587517

A Clinical Trial of Interventions to Support Family Surrogates of Critically Ill Patients

Recruiting
PHASE2Ages 18+InterventionalTreatment
Weill Medical College of Cornell University
~172 participants
Updated 2025-10-29 on ClinicalTrials.gov
What's tested:EMPOWERSupportive Conversation

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change of Prolonged Grief Disorder
Measured over from baseline through twelve-month follow-up
+2 more outcomes measured

Conditions

Grief
Trauma
Psychotherapy
Critical Care

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Critical CareGriefInjury

Where it's being run

3 sites across 2 states
New York2
Florida1

Study leadership

  • Holly Prigerson, PhD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University
  • Wendy Lichtenthal, PhD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Holly Prigerson, PhD
[email protected]
212-746-1374
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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change of Prolonged Grief Disorderfrom baseline through twelve-month follow-up

    Symptoms of prolonged grief disorder, as measured by the Prolonged Grief-13-Revised, will be compared between the week following the intervention, at one month follow-up and at twelve-month follow-up . The PG-13-R consists of 13 items and total score can range from 0 to 62. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.

  • Change of Post-Traumatic Stress DisorderFrom baseline through twelve-month follow-up

    Symptoms of post-traumatic stress disorder, as measured by the Impact of Events Scale-Revised, will be compared between groups at baseline through twelve-month follow up assessments . The IES-R consists of 22 items and total score can range from 0 to 88. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.

  • Change of Anticipatory Grieffrom baseline through twelve-month follow-up

    Symptoms of anticipatory grief, as measured by the PG-12-R, consists of 12 items using a 5-point Likert scale. Total scores range from 11 to 55, with higher scores representing greater anticipatory grief.