Your session is about to expire
← Back to Search
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
Study 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline through twelve-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through twelve-month follow-up
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 moreOther outcome measures
Dissociation
Change of Distress Tolerance
Change of General Physical and General Mental Health
+4 moreTrial 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
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,704 Total Patients Enrolled
1 Trials studying Grief
22 Patients Enrolled for Grief
National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,389 Total Patients Enrolled
1 Trials studying Grief
682 Patients Enrolled for Grief
Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,123 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My surrogate decision-maker speaks English.My decision-maker is at least 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: EMPOWER arm
- Group 2: Supportive Conversation arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Why was this clinical trial established?
"This clinical trial seeks to evaluate the efficacy of a new treatment for post-traumatic stress disorder (PTSD) over a 12-month period. Secondary outcomes that will be measured include changes in levels of regret, peritraumatic distress, and depression."
Answered by AI
Is it possible to join this clinical trial at the current moment?
"That is correct, the listing on clinicaltrials.gov verifies that this trial is looking for more participants. The original posting date was October 20th, 2022 and there have been edits made as recently as November 9th, 2022. Right now, they are enrolling 172 people total from 1 location."
Answered by AI
How risky is it for people to be enrolled in the EMPOWER arm of this trial?
"The EMPOWER arm of this study has only been proven safe in Phase 2 trials, so it received a score of 2."
Answered by AI
How many people are part of this experiment?
"That is correct. The information on clinicaltrials.gov supports that this trial is currently recruiting patients. This study was first posted on October 20th, 2020 and was last updated November 9th, 2020. They are looking for a total of 172 patients at 1 location."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger