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

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

Interventions

BEHAVIORAL

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.

OTHER

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.

Sponsors & Collaborators

• National Institute of Nursing Research (NINR)

  collaborator NIH

• Weill Medical College of Cornell University

  lead OTHER

Principal Investigators

• Holly Prigerson, PhD · Weill Medical College of Cornell University

• Wendy Lichtenthal, PhD · University of Miami

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-10-11

Primary Completion

2027-12-11

Completion

2027-12-11

Countries

• United States

Study Locations