NCT05587517 · Weill Medical College of Cornell University
A Clinical Trial of Interventions to Support Family Surrogates of Critically Ill Patients
What this study is about
Hypotheses 1a and 1b: Compared to Supportive Conversation treatment group$1, the EMPOWER intervention will significantly decrease surrogate decision makers' symptoms of grief and Post Traumatic Stress Disorder (PTSD) (primary outcomes); and H1b. experiential avoidance, depression, regrets, and increases in patients' value-concordant care (secondary outcomes) at T1-T4. Hypothesis 2.
View original scientific description
Hypotheses 1a and 1b: Compared to Supportive Conversation arm, the EMPOWER intervention will significantly decrease surrogate decision makers' symptoms of grief and Post Traumatic Stress Disorder (PTSD) (primary outcomes); and H1b. experiential avoidance, depression, regrets, and increases in patients' value-concordant care (secondary outcomes) at T1-T4. Hypothesis 2. Qualitative data will provide insights not captured by quantitative data. Hypothesis 3.
Interventions
BEHAVIORAL
EMPOWER
EMPOWER is a manualized treatment delivered based in cognitive behavioral and acceptance and commitment therapies delivered by a trained mental health professional that utilizes breathing and grounding exercises, mindfulness meditation, psychoeducation, imaginal dialogue with the patient, and coping rehearsal techniques. The total amount of time EMPOWER intervention is about 90 minutes, about 15 minutes each module. It can either be administered in one session or many sessions to accommodate the dynamic nature of ICU, and has two booster follow-up calls (roughly 45 minutes each) in the month following initial treatment.
OTHER
Supportive Conversation
The Supportive Conversation will match the time and attention offered through EMPOWER, so will be about 1.5-2 hours and will have two additional follow-up calls.
Primary outcome measures
Change of Prolonged Grief Disorder
Time frame: from 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 Disorder
Time frame: From 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 Grief
Time frame: from 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 de
Where
- Miami, Florida
- New York, New York
Collaborators
National Institute of Nursing Research (NINR)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 29, 2025 · Source of record for eligibility and locations