What is EMPOWER studying for family surrogates of critically ill patients?

EMPOWER is being studied as a psychological intervention to reduce grief and post-traumatic stress symptoms in family members making medical decisions for critically ill patients. Researchers want to understand how this approach may support emotional resilience and improve decision-making during difficult end-of-life situations. This trial is led by Weill Medical College of Cornell University.

Who may be eligible for this grief and trauma clinical trial?

Adults 18 years or older who are surrogate decision makers for patients admitted to the ICU near end-of-life may be eligible. Participants must speak English, show significant grief or distress symptoms, and be able to use internet-connected devices. Please review eligibility criteria for more details.

Is there any cost to participate in this grief and trauma clinical trial?

Study-related care, including the study intervention and all trial visits, is provided at no cost. Personal travel or device expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

Healthy Volunteers

ID05587517

Phase 2 Trial of EMPOWER vs Supportive Conversation to Help Family Surrogate Decision Makers of Critically Ill Patients Reduce Grief and PTSD Symptoms

Led by Weill Medical College of Cornell University · Updated on 2025-10-29

172

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate interventions to support family members who act as surrogate decision makers for critically ill patients in Intensive Care Units ICUs. These surrogates often face intense grief and stress that can affect their mental health and the quality of decisions made for their loved ones near end-of-life. The study focuses on reducing symptoms of prolonged grief disorder PGD, post-traumatic stress disorder PTSD, and related emotional challenges through a psychological intervention called EMPOWER. The study compares two approaches the EMPOWER intervention, which is a brief, cognitive-behavioral and acceptance-based treatment delivered by trained mental health professionals, and a Supportive Conversation SC that provides empathetic support without specific skill-building. EMPOWER includes six 15-minute modules and two booster phone sessions, totaling about 90 minutes plus follow-ups, while the Supportive Conversation matches this time with supportive interaction and follow-up calls. Participants are assessed up to four times before and after the intervention within three months. Participants, who are surrogate decision makers of ICU patients near end-of-life, will complete assessments on grief, PTSD, depression, regret, anxiety, and distress before the intervention, immediately after, and at 3 and 12 months follow-up. The study also includes interviews with some participants to better understand the interventions effects and contextual factors during the COVID-19 pandemic. The primary outcomes focus on changes in grief and PTSD symptoms over twelve months, with safety and mental health monitored throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Patients admitted to the ICU near end-of-life, as identified by physicians expecting no survival beyond 12 months.
Surrogate decision makers of patients admitted to ICU or step-down unit during current or recent hospital stay.
Surrogate decision makers aged 18 years or older.
Surrogates designated as health care proxies or decision makers by medical staff or self-report.
Surrogate decision makers who speak English.
Surrogate decision makers with significant pre-loss grief or distress symptoms (PG-12 score ≥ 25 or PDI ≥ 23).
Surrogates residing in states where the interventionist is licensed or able to comply with telehealth rules.
Surrogate decision makers willing and able to use internet-enabled devices.
Surrogate decision makers able and willing to provide an emergency contact.

You will not qualify if you...

Patients and surrogates not meeting inclusion criteria.
Surrogate decision makers with cognitive impairment or psychiatric conditions preventing study participation.
Surrogates reporting suicidal thoughts in the past month.
Surrogate decision makers unable to access or unwilling to use a functional device for videoconferencing.

Research Team

Holly Prigerson, PhD

Hillary Winoker, B.A.

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