GriefPhase 2NCT05587517
A Clinical Trial of Interventions to Support Family Surrogates of Critically Ill Patients
A Phase 2 study testing EMPOWER and Supportive Conversation in people with Grief and Trauma, run by Weill Medical College of Cornell University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Grief, Trauma, Psychotherapy
- What is being tested?
- EMPOWER and Supportive Conversation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Oct 2022to 11 Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Miami
Miami, Florida, 33136
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
NewYork-Presbyterian Weill Cornell Medicine
New York, New York, 10065
About this study
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.
Read the detailed description
Intensive Care Units (ICUs) are stressful places fraught with grief for family members who witness dying loved ones, often in pain, struggling to breathe and/or maintain consciousness. Compounding their distress, family members are often thrust into the position of patient "surrogate," needing to make life-and-death decisions on the patient's behalf. Researchers have shown that end-of-life (EoL) decision-making is undermined by grief, which interferes with acceptance of the patient's impending death and leads to care choices that adversely affect patients' quality of care and death.1-3 These circumstances heighten surrogates' risk of meeting criteria for Prolonged Grief Disorder (PGD), Posttraumatic Stress Disorder (PTSD), and decisional regret about the EoL care that the patient received, each associated with poor bereavement outcomes.4-7 Nearly 60% of ICU surrogates report moderate to extreme grief; 34% report extreme levels of peritraumatic stress symptoms.1
The coronavirus (COVID-19) pandemic has made an already bad situation worse. At the start of the pandemic, social distancing policies forced millions of families to confront obstacles to communication, medical decision-making, and care.8-10 Surrogates were left struggling with severe pre-loss grief and peritraumatic stress -- intensely longing to be near to the patient, confused about their roles, lonely, horrified, angry, disoriented and emotionally numb.10,11 Now, as the Delta variant creates a new "wave" of mortality and infection, bereaved family members may have remorse about vaccine refusal,12 feel guilty for transmitting the virus to the patient, or regret decisions about EoL care. With over 35 million cases and 600,000 deaths in the United States from COVID-19,13 the need for psychosocial interventions to support surrogates in the ICU is clear.
Prior efforts to address the plight of family surrogates of critically ill patients have proved disappointing14-20 - with one ICU intervention significantly increasing the surrogate's severity of PTSD symptoms.14 A key limitation of these interventions is that while they targeted psychological outcomes, they were not psychological interventions. To address this, the investigators developed a brief, flexibly administered cognitive-behavioral, acceptance-based psychological intervention called EMPOWER (Enhancing \& Mobilizing the POtential for Wellness \& Emotional Resilience).21,22 Our pilot NIH-R21 (N=39) showed that EMPOWER had superior efficacy to enhanced usual care for reducing symptoms of PGD (d=1.20) and PTSD (d=.99). Consistent with mediation, EMPOWER reduced experiential avoidance (d=1.20); these reductions were correlated with PGD and PTSD change scores (p<0.01). Large reductions in decisional regret (d=1.57) were observed, with no notable differences by surrogate race or delivery format (telehealth vs. in-person).
Investigators propose to conduct a Phase II mixed methods randomized controlled trial (RCT) to further evaluate the efficacy of EMPOWER for reducing surrogate symptoms of PTSD and PGD. Surrogates (N=172) will be randomized to EMPOWER (n=86) or a standardized supportive conversation (SC; n=86). Effects of the intervention will be assessed via measures administered pre-intervention (T1), immediately post-intervention (T2), and at 3 months (T3), and 12 months (T4) following the T2 assessment. Investigators will also conduct semi-structured interviews with surrogates (n≈48) to probe intervention effects on mental health and explore contextual factors (e.g., medical mistrust, visitation restrictions) likely to affect surrogates during the pandemic.
- Conditions
- Grief, Trauma, Psychotherapy, Critical Care
- Being tested
- EMPOWER, Supportive Conversation
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMPOWERBehavioural
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 ConversationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Supportive Conversation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: from baseline through twelve-month follow-up
Secondary outcomes (4)
Change of Depression
Symptoms of depression, as measured by the Hospital Anxiety and Depression Scale (HADS), will be compared between groups at from baseline through twelve-month follow-up . HADS consists of 7 questions in their 14-item scale that assess depression. Higher scores indicate higher symptom burden. Lower scores represent a normal range.
Measured: From baseline through twelve-month follow-up
Change of Regret
Regret, as measured by the Decision Regret Scale, will be compared between groups at baseline through twelve-month follow-up . The decision regret scale is a one-item likert-style measure. Total scores can range from 5 to 25. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Measured: From baseline through twelve-month follow-up
Change of Peritraumatic Distress
Symptoms of peritraumatic distress, as measured by the Peritraumatic Distress Inventory (adapted to fi the ICU experience), will be compared between groups in the week following the intervention through the twelve-month-follow up . The PDI consists of 13 likert-style items and total score can range from 0 to 52. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Measured: 1 week following the intervention through twelve-month follow-up .
Change of Anxiety
Symptoms of anxiety, as measured by the Hospital Anxiety and Depression Scale (HADS), will be compared between groups at from baseline through twelve-month follow-up ). HADS consists of 7 questions in their 14-item scale that assess anxiety. Higher scores indicate higher symptom burden. Lower scores represent a normal range.
Measured: From baseline through twelve-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start11 Oct 2022
- Primary completion31 Jan 2027 (estimated)
- Study completion11 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (82)Papers the sponsor has linked to this study.
- Other trials for GriefStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mixed methods randomized controlled trial (RCT) to further evaluate the efficacy of EMPOWER for reducing surrogate symptoms of PTSD and PGD.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Holly Prigerson, PhD, Principal investigator, Weill Medical College of Cornell UniversityWendy Lichtenthal, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587517
- Sponsor's protocol ID
- 21-09023929
- Other IDs
- R01NR019831
- Status last verified
- Sep 2026
- First submitted
- 17 Oct 2022
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All participant data, including self-report measures and qualitative interviews, will be shared to qualified investigators under a Data Use Agreement in de-identifiable form. Data will be made available upon approval of PIs and will be used solely for research purposes.
Publications
Derry HM, Lief L, Schenck EJ, Berlin DA, Prigerson HG. Peritraumatic Stress among Caregivers of Patients in the Intensive Care Unit. Ann Am Thorac Soc. 2020 May;17(5):650-654. doi: 10.1513/AnnalsATS.201908-647RL. No abstract available.
PubMed 32068429Givens JL, Prigerson HG, Kiely DK, Shaffer ML, Mitchell SL. Grief among family members of nursing home residents with advanced dementia. Am J Geriatr Psychiatry. 2011 Jun;19(6):543-50. doi: 10.1097/JGP.0b013e31820dcbe0.
PubMed 21606897Maciejewski PK, Prigerson HG. Emotional numbness modifies the effect of end-of-life discussions on end-of-life care. J Pain Symptom Manage. 2013 May;45(5):841-7. doi: 10.1016/j.jpainsymman.2012.04.003. Epub 2012 Aug 25.
PubMed 22926093Siegel MD, Hayes E, Vanderwerker LC, Loseth DB, Prigerson HG. Psychiatric illness in the next of kin of patients who die in the intensive care unit. Crit Care Med. 2008 Jun;36(6):1722-8. doi: 10.1097/CCM.0b013e318174da72.
PubMed 18520637Wright AA, Keating NL, Balboni TA, Matulonis UA, Block SD, Prigerson HG. Place of death: correlations with quality of life of patients with cancer and predictors of bereaved caregivers' mental health. J Clin Oncol. 2010 Oct 10;28(29):4457-64. doi: 10.1200/JCO.2009.26.3863. Epub 2010 Sep 13.
PubMed 20837950Wright AA, Zhang B, Ray A, Mack JW, Trice E, Balboni T, Mitchell SL, Jackson VA, Block SD, Maciejewski PK, Prigerson HG. Associations between end-of-life discussions, patient mental health, medical care near death, and caregiver bereavement adjustment. JAMA. 2008 Oct 8;300(14):1665-73. doi: 10.1001/jama.300.14.1665.
PubMed 18840840Zhang B, Nilsson ME, Prigerson HG. Factors important to patients' quality of life at the end of life. Arch Intern Med. 2012 Aug 13;172(15):1133-42. doi: 10.1001/archinternmed.2012.2364.
PubMed 22777380Bronsther R. Visitor Restrictions During COVID-19 Pandemic May Impact Surrogate Medical Decision-Making. J Patient Exp. 2020 Aug;7(4):428-429. doi: 10.1177/2374373520938489. Epub 2020 Jun 30. No abstract available.
PubMed 33062852Greenberg JA, Basapur S, Quinn TV, Bulger JL, Glover CM, Shah RC. Psychological Symptoms Among Surrogates of Critically Ill Patients During and Before the COVID-19 Pandemic. Chest. 2021 Jun;159(6):2318-2320. doi: 10.1016/j.chest.2020.12.056. Epub 2021 Jan 12. No abstract available.
PubMed 33444615Lamas D. I'm on the Front Lines. I Have No Plan for This. The New York Times. March 24, 2020.
Wood J. These Harvard scientists think we'll have to socially distance until 2022. World Economic Forum2020, April 20.
Luisa Paul M. People who have lost their loved ones to covid-19 are getting vaccinated, Alabama doctor says. The Washington Post2021.
Centers for Disease Control and Prevention. COVIDView: A Weekly Surveillance Summary of U.S. COVID-19 Activity. 2021; https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html.
Carson SS, Cox CE, Wallenstein S, Hanson LC, Danis M, Tulsky JA, Chai E, Nelson JE. Effect of Palliative Care-Led Meetings for Families of Patients With Chronic Critical Illness: A Randomized Clinical Trial. JAMA. 2016 Jul 5;316(1):51-62. doi: 10.1001/jama.2016.8474.
PubMed 27380343Cox C, Monk A. Minority caregivers of dementia victims: A comparison of Black and Hispanic families. Journal of Applied Gerontology. 1990;9(3):340-354.