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Family Support Program for Critical Illness

Phase 2
Recruiting
Led By Wendy Lichtenthal, PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through twelve-month follow-up
Awards & highlights

Summary

This trial tests how a program to support decision-makers facing end-of-life decisions affects their emotional wellbeing.

Who is the study for?
This trial is for adult surrogate decision-makers of critically ill ICU patients near end-of-life. They must speak English, be able to use a device with internet, and live where the interventionist is licensed. Participants need to show significant pre-loss grief or distress but can't have cognitive impairments or recent suicidal ideation.Check my eligibility
What is being tested?
The study tests if the EMPOWER program better reduces symptoms of grief and PTSD in surrogates compared to just having supportive conversations. It also looks at depression, regrets, and how well patient care matches their values over time.See study design
What are the potential side effects?
Since this trial involves psychotherapy interventions rather than medications, traditional side effects are not applicable. However, participants may experience emotional discomfort discussing sensitive topics.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through twelve-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline through twelve-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change of Anticipatory Grief
Post-Traumatic Stress Disorder
Prolonged grief disorder
Secondary outcome measures
Anxiety
Change of Depression
Fetal Distress
+1 more
Other outcome measures
Dissociation
Change of Distress Tolerance
Change of General Physical and General Mental Health
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EMPOWER armExperimental Treatment1 Intervention
The EMPOWER arm includes six 15 minute modules delivered in a 1-on-1 format with the same interventionist, and 2 boosters (approximately 45 minutes each) conducted by phone. Subjects who meet eligibility criteria will receive up to 4 sequential assessments before and after the EMPOWER intervention within 3 months conducted in person and by phone.
Group II: Supportive Conversation armPlacebo Group1 Intervention
The Supportive Conversation (SC) arm includes a supportive, empathic encounter without specific skill-building for approximately the same amount of time as EMPOWER. Subjects who meet eligibility criteria will receive up to 4 sequential assessments before and after SC within 3 months conducted in person and by phone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EMPOWER
2022
N/A
~130

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for grief, such as brief dynamic psychotherapy and mutual-help group treatment, work by providing emotional support and facilitating the expression of grief-related emotions. The EMPOWER intervention, specifically, aims to reduce grief and PTSD symptoms by targeting experiential avoidance, which is the tendency to avoid thoughts, feelings, and memories associated with the loss. By addressing experiential avoidance, these treatments help patients confront and process their grief, leading to reduced symptoms of depression, PTSD, and regret, and promoting value-concordant care. This is crucial for grief patients as it enables them to integrate their loss into their lives in a healthy way, improving overall emotional well-being and functioning.
A controlled trial of brief psychotherapy and mutual-help group treatment of conjugal bereavement.Optimizing Treatment of Complicated Grief: A Randomized Clinical Trial.

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,736 Previous Clinical Trials
7,507,778 Total Patients Enrolled
1 Trials studying Grief
22 Patients Enrolled for Grief
National Institute of Nursing Research (NINR)NIH
588 Previous Clinical Trials
10,379,809 Total Patients Enrolled
2 Trials studying Grief
1,097 Patients Enrolled for Grief
Weill Medical College of Cornell UniversityLead Sponsor
1,064 Previous Clinical Trials
1,319,014 Total Patients Enrolled

Media Library

EMPOWER Clinical Trial Eligibility Overview. Trial Name: NCT05587517 — Phase 2
Grief Research Study Groups: EMPOWER arm, Supportive Conversation arm
Grief Clinical Trial 2023: EMPOWER Highlights & Side Effects. Trial Name: NCT05587517 — Phase 2
EMPOWER 2023 Treatment Timeline for Medical Study. Trial Name: NCT05587517 — Phase 2
~111 spots leftby Dec 2027