Peritraumatic Stress among Caregivers of Patients in the Intensive Care Unit.
Heather M Derry, Lindsay Lief, Edward J Schenck...
https://pubmed.ncbi.nlm.nih.gov/32068429Actively Recruiting
Phase 2
Age: 18Years +
All Genders
Healthy Volunteers
ID05587517
A Clinical Trial of Interventions to Support Family Surrogates of Critically Ill Patients
Led by Weill Medical College of Cornell University · Updated on 2025-10-29
172
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
N
National Institute of Nursing Research (NINR)
Collaborating Sponsor
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 intervention's 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.
AI-Screening
AI-Powered Screening
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2
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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
Trial Site Locations
Total: 3 locations
1
University of Miami
Miami, Florida, United States, 33136
Not Yet Recruiting
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Actively Recruiting
3
NewYork-Presbyterian Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
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Research Team
H
Holly Prigerson, PhD
H
Hillary Winoker, B.A.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Jane L Givens, Holly G Prigerson, Dan K Kiely...
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Mark D Siegel, Earle Hayes, Lauren C Vanderwerker...
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Alexi A Wright, Nancy L Keating, Tracy A Balboni...
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Alexi A Wright, Baohui Zhang, Alaka Ray...
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Baohui Zhang, Matthew E Nilsson, Holly G Prigerson
https://pubmed.ncbi.nlm.nih.gov/22777380Visitor Restrictions During COVID-19 Pandemic May Impact Surrogate Medical Decision-Making.
Rachel Bronsther
https://pubmed.ncbi.nlm.nih.gov/33062852Psychological Symptoms Among Surrogates of Critically Ill Patients During and Before the COVID-19 Pandemic.
Jared A Greenberg, Santosh Basapur, Thomas V Quinn...
https://pubmed.ncbi.nlm.nih.gov/33444615Effect of Palliative Care-Led Meetings for Families of Patients With Chronic Critical Illness: A Randomized Clinical Trial.
Shannon S Carson, Christopher E Cox, Sylvan Wallenstein...
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