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

Part of paid clinical trials in Miami, Florida.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT05587517
Phase
PHASE2
Status
Recruiting
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Conditions

  • Critical Care
  • Grief
  • Psychotherapy
  • Trauma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Oct 11, 2022
Status verified
Oct 2025
Primary completion
Dec 11, 2027
Completion
Dec 11, 2027

Study Design

Enrollment
172 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Change of Prolonged Grief Disorder [ Time Frame: from baseline through twelve-month follow-up ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Wendy Lichtenthal, Ph.D.
[email protected]
305-243-8983
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021
Rosario Costas-Muñiz
646-888-8062
Rosario Costas-Muñiz, PhD (PRINCIPAL_INVESTIGATOR)
NewYork-Presbyterian Weill Cornell MedicineNew YorkNew York10065
Hillary Winoker, B.A.
[email protected]
646-962-7143
Holly G Prigerson, PhD
[email protected]
212-746-1374
Holly G Prigerson, PhD (PRINCIPAL_INVESTIGATOR)

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