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

NCT05587517 | Recruiting Phase 2 DMC

• 2 other identifiers: 21-09023929R01NR019831
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 3

Brief Summary

Hypotheses 1a and 1b: Compared to Supportive Conversation arm, the EMPOWER intervention will significantly decrease surrogate decision makers' symptoms of grief and Post Traumatic Stress Disorder (PTSD) (primary outcomes); and H1b. experiential avoidance, depression, regrets, and increases in patients' value-concordant care (secondary outcomes) at T1-T4. Hypothesis 2. Qualitative data will provide insights not captured by quantitative data. Hypothesis 3. Reductions in experiential avoidance will mediate reductions in grief and Post Traumatic Stress Disorder (PTSD) symptoms, highlighting it as important to target in future implementation.

Conditions

Grief; Trauma; Psychotherapy; Critical Care

Outcome Measures

Primary Outcomes (3)

• Change of Prolonged Grief Disorder

  Symptoms of prolonged grief disorder, as measured by the Prolonged Grief-13-Revised, will be compared between the week following the intervention, at one month follow-up and at twelve-month follow-up . The PG-13-R consists of 13 items and total score can range from 0 to 62. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.

  from baseline through twelve-month follow-up

• Change of Post-Traumatic Stress Disorder

  Symptoms of post-traumatic stress disorder, as measured by the Impact of Events Scale-Revised, will be compared between groups at baseline through twelve-month follow up assessments . The IES-R consists of 22 items and total score can range from 0 to 88. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.

  From baseline through twelve-month follow-up

• Change of Anticipatory Grief

  Symptoms of anticipatory grief, as measured by the PG-12-R, consists of 12 items using a 5-point Likert scale. Total scores range from 11 to 55, with higher scores representing greater anticipatory grief.

  from baseline through twelve-month follow-up

Secondary Outcomes (4)

• Change of Depression

  From baseline through twelve-month follow-up

• Change of Regret

  From baseline through twelve-month follow-up

• Change of Peritraumatic Distress

  1 week following the intervention through twelve-month follow-up .

• Change of Anxiety

  From baseline through twelve-month follow-up

Other Outcomes (7)

• Change of Dissociation

  From baseline to the 1 week following the intervention

• Change of Distress Tolerance

  From baseline through twelve-month follow-up

• Change of Surrogate's Quality of Life

  From the 1 week following the intervention through twelve-month follow-up

Study Arms (2)

EMPOWER arm

EXPERIMENTAL

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.

Behavioral: EMPOWER

Supportive Conversation arm

PLACEBO COMPARATOR

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.

Other: Supportive Conversation

Interventions

EMPOWER BEHAVIORAL

EMPOWER is a manualized treatment delivered based in cognitive behavioral and acceptance and commitment therapies delivered by a trained mental health professional that utilizes breathing and grounding exercises, mindfulness meditation, psychoeducation, imaginal dialogue with the patient, and coping rehearsal techniques. The total amount of time EMPOWER intervention is about 90 minutes, about 15 minutes each module. It can either be administered in one session or many sessions to accommodate the dynamic nature of ICU, and has two booster follow-up calls (roughly 45 minutes each) in the month following initial treatment.

EMPOWER arm

Supportive Conversation OTHER

The Supportive Conversation will match the time and attention offered through EMPOWER, so will be about 1.5-2 hours and will have two additional follow-up calls.

Supportive Conversation arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who, during their hospital stay, have been admitted to the ICU and are near EoL, as indicated by a modified "surprise question" whereby physicians are asked to identify patients whom they do not expect to survive the next 12 months.
• Surrogate decision-makers of patients who were admitted to the ICU or step-down unit during their current admission/stay, or within 1 month of discharge from their last admission/stay.
• Surrogate decision-makers are 18 years or older.
• Surrogate decision-makers whom physicians or advance practice providers (i.e. physician assistants, nurse practitioners) indicate as the designated health care proxy or decision-making patient surrogates, or who are listed as such in the patient's medical charts or by self-report of the surrogate.
• Surrogate decision-makers must speak English.
• Surrogate decision-makers must report "syndromal" levels of pre-loss grief (PG-12 score ≥ 25) or peritraumatic distress (PDI ≥ 23).
• Surrogate decision makers will need to reside in a state in which an interventionist is licensed or otherwise be able to comply with current telehealth regulations.
• Surrogate decision-makers will need to be willing to utilize a device (computer, tablet, phone) with internet.
• Surrogate decision-makers who are able and willing to provide an emergency contact.

You may not qualify if:

• Patients and surrogate decision-makers who do not meet the eligibility criteria.
• Surrogate decision-makers who indicate the presence of cognitive impairment based on responses to the Ultra-Brief Confusion Assessment Method and/or significant psychiatric or cognitive disturbance sufficient, in the investigator/study staff's judgment, to preclude completion of the assessment measures, interview or informed consent.
• Surrogate-decision makers who endorse suicidal ideation in the past month based on responses to the Columbia Suicide Severity Rating Scale.
• Surrogate-decision makers who are unable to access a functional device for videoconferencing and decline the offer to use a study loner device.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (3)

University of Miami

Miami, Florida, 33136, United States

NOT YET RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

RECRUITING

NewYork-Presbyterian Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

Related Publications (81)

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MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Holly Prigerson, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Wendy Lichtenthal, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Holly Prigerson, PhD

CONTACT

212-746-1374; hgp2001@med.cornell.edu

Hillary Winoker, B.A.

CONTACT

646-962-7143; hiw4002@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Mixed methods randomized controlled trial (RCT) to further evaluate the efficacy of EMPOWER for reducing surrogate symptoms of PTSD and PGD.

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 20, 2022
• Study Start: October 11, 2022
• Primary Completion (Estimated): December 11, 2027
• Study Completion (Estimated): December 11, 2027
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available once the study's specific aims will be published and will be destroyed once analyses are completed.
• Access Criteria: Accessing data requires making a formal request at the appropriate time and the PIs and investigative team will review the request. If approved, the data analyst from our Cornell Center for Research on End-of-Life Care will make a de-identifiable dataset to address the analyses in the request.

Locations

US (3)