Recruiting
Phase 2

Observational Study

Sponsor:

Weill Medical College of Cornell University

Code:

NCT05587517

Conditions

Grief

Trauma

Psychotherapy

Critical Care

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

EMPOWER

Supportive Conversation

Study Details

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

Study ID

NCT05587517

Start date

Oct 11, 2022

Status verified date

Oct, 2025

Completion date

Dec 11, 2027

Anticipated

Primary completion date

Dec 11, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

172 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: EMPOWER arm

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.

placebo comparator: Supportive Conversation arm

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.

Interventions

EMPOWER

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.

Supportive Conversation

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.

Primary outcome measure

  • Change of Prolonged Grief Disorder [ Time Frame: from baseline through twelve-month follow-up ]
  • Change of Post-Traumatic Stress Disorder [ Time Frame: From baseline through twelve-month follow-up ]
  • Change of Anticipatory Grief [ Time Frame: from baseline through twelve-month follow-up ]

Central Contacts and Locations

Central contacts

Holly Prigerson, PhD

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

Hillary Winoker, B.A.

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

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10021

Contacts

Rosario Costas-Muñiz

646-888-8062

Principal Investigator:

Rosario Costas-Muñiz, PhD

NewYork-Presbyterian Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Hillary Winoker, B.A.

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

Holly G Prigerson, PhD

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

Principal Investigator:

Holly G Prigerson, PhD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2025-10-29.