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

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	EMPOWER	Supportive Conversation
What it is	A structured behavioral therapy for ICU surrogate decision-makers, combining cognitive behavioral and acceptance and commitment therapy elements, delivered by a trained mental health professional. Includes mindfulness, psychoeducation, grounding techniques, imaginal dialogue, and coping practice.	A conversational support session provided by a trained professional, matched for time spent and attention. Does not use structured therapeutic modules but offers empathic listening and practical support.
Role in trial	Investigational therapy being evaluated for its impact on grief and trauma symptoms among surrogate decision-makers.	Comparator arm, designed to match intervention contact but without targeted therapeutic content.
Primary use	Designed to reduce syndromal pre-loss grief, peritraumatic distress, and related emotional symptoms in surrogate decision-makers during the critical illness of loved ones.	Provides emotional and informational support with empathic listening, attention, and practical conversation. Serves as a time- and attention-matched control.
How it is given or performed	Delivered via videoconference or in person by a trained professional. Involves a main treatment session (approx. 90 minutes) broken into up to six modules (15 minutes each), in one or more sessions; followed by two 45-minute booster calls within a month.	Delivered by a trained professional over videoconference or in person. Matches EMPOWER in total length: 1.5–2 hours, plus two follow-up calls. No structured modules.
Evidence status	EMPOWER is under study in this trial. Early research supports targeting grief and emotional stress using structured therapy for ICU surrogates, but outcome evidence is not yet fully established.	Supportive conversation serves as a control for general psychosocial support. Evidence from similar trials suggests that empathic communication alone is sometimes insufficient to reduce prolonged grief or trauma symptoms.
Important limitations	As an investigational therapy, its full benefit and optimal implementation among diverse surrogate decision-makers remains unproven until completion of this and other ongoing studies.	Supportive conversation does not deploy structured therapeutic tools specifically targeting grief or trauma and may not address all dimensions of caregiver distress.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

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.

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Up to 4 sequential assessments conducted in person and by phone before the intervention

Outpatient Treatment

Duration - Approximately 1.5 to 2 hours total for the initial intervention, plus two booster follow-up calls over the following month

Participants receive either the EMPOWER cognitive-behavioral intervention or a supportive conversation designed to provide empathic support without specific skill-building.

Initial 1-on-1 session followed by 2 booster phone calls in the month after treatment

Follow-up

Duration - 12 months following the intervention

Participants complete assessments immediately post-intervention and at 3 and 12 months to evaluate mental health outcomes.

Assessments conducted immediately post-intervention, and at 3 and 12 months by phone or in person