What is the mechanism of action of this treatment?

Common treatments for grief, such as brief dynamic psychotherapy and mutual-help group treatment, work by providing emotional support and facilitating the expression of grief-related emotions. The EMPOWER intervention, specifically, aims to reduce grief and PTSD symptoms by targeting experiential avoidance, which is the tendency to avoid thoughts, feelings, and memories associated with the loss. By addressing experiential avoidance, these treatments help patients confront and process their grief, leading to reduced symptoms of depression, PTSD, and regret, and promoting value-concordant care. This is crucial for grief patients as it enables them to integrate their loss into their lives in a healthy way, improving overall emotional well-being and functioning.

What side effects are associated with this type of intervention?

Common treatments for grief, such as cognitive-behavioral therapy (CBT) and other psychotherapies, generally have minimal physical side effects. However, patients may experience emotional discomfort as they confront and process painful memories and emotions. Some individuals might feel increased anxiety or distress during the initial stages of therapy. It is also possible for patients to experience temporary fatigue or emotional exhaustion after sessions. Overall, these side effects are typically mild and transient, and the benefits of therapy often outweigh these temporary discomforts.

What prior FDA approvals exist?

There are no specific FDA-approved medications for the treatment of grief. However, treatments for related conditions such as depression and PTSD, which often accompany grief, include selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). Behavioral interventions like the EMPOWER intervention, which targets experiential avoidance to reduce grief and PTSD symptoms, are also being studied and show promise in addressing these complex emotional states.

What other types of research exist?

Promising novel alternatives to the EMPOWER intervention for grief patients include Cognitive Behavioral Therapy (CBT), Eye Movement Desensitization and Reprocessing (EMDR), and Mindfulness-Based Cognitive Therapy (MBCT). These therapies have shown efficacy in treating PTSD and related symptoms, which are often associated with grief. Additionally, integrative approaches such as guided imagery, progressive muscle relaxation, and biofeedback-assisted relaxation have demonstrated potential in managing symptoms of grief and PTSD.

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Family Support Program for Critical Illness

Phase 2

Recruiting

Led By Wendy Lichtenthal, PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline through twelve-month follow-up

Awards & highlights

Summary

This trial tests EMPOWER, a psychological therapy designed to help family members who make medical decisions for critically ill patients in ICUs. The therapy aims to reduce grief and stress by teaching coping strategies that help people accept and manage their emotions. Researchers hope this will improve mental health outcomes and decision-making abilities for these family members.

Who is the study for?

This trial is for adult surrogate decision-makers of critically ill ICU patients near end-of-life. They must speak English, be able to use a device with internet, and live where the interventionist is licensed. Participants need to show significant pre-loss grief or distress but can't have cognitive impairments or recent suicidal ideation.

What is being tested?

The study tests if the EMPOWER program better reduces symptoms of grief and PTSD in surrogates compared to just having supportive conversations. It also looks at depression, regrets, and how well patient care matches their values over time.

What are the potential side effects?

Since this trial involves psychotherapy interventions rather than medications, traditional side effects are not applicable. However, participants may experience emotional discomfort discussing sensitive topics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline through twelve-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline through twelve-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline through twelve-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change of Anticipatory Grief

Post-Traumatic Stress Disorder

Prolonged grief disorder

Secondary study objectives

Anxiety

Change of Depression

Fetal Distress

+1 more

Other study objectives

Dissociation

Change of Distress Tolerance

Change of General Physical and General Mental Health

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EMPOWER armExperimental Treatment1 Intervention

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.

Group II: Supportive Conversation armPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EMPOWER

2022

N/A

~100

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for grief, such as brief dynamic psychotherapy and mutual-help group treatment, work by providing emotional support and facilitating the expression of grief-related emotions. The EMPOWER intervention, specifically, aims to reduce grief and PTSD symptoms by targeting experiential avoidance, which is the tendency to avoid thoughts, feelings, and memories associated with the loss. By addressing experiential avoidance, these treatments help patients confront and process their grief, leading to reduced symptoms of depression, PTSD, and regret, and promoting value-concordant care. This is crucial for grief patients as it enables them to integrate their loss into their lives in a healthy way, improving overall emotional well-being and functioning.

A controlled trial of brief psychotherapy and mutual-help group treatment of conjugal bereavement.Optimizing Treatment of Complicated Grief: A Randomized Clinical Trial.

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,765 Previous Clinical Trials

8,133,339 Total Patients Enrolled

1 Trials studying Grief

22 Patients Enrolled for Grief

National Institute of Nursing Research (NINR)NIH

598 Previous Clinical Trials

10,377,990 Total Patients Enrolled

2 Trials studying Grief

1,097 Patients Enrolled for Grief

Weill Medical College of Cornell UniversityLead Sponsor

1,077 Previous Clinical Trials

1,320,495 Total Patients Enrolled

Media Library

EMPOWER Clinical Trial Eligibility Overview. Trial Name: NCT05587517 — Phase 2

Grief Research Study Groups: EMPOWER arm, Supportive Conversation arm

Grief Clinical Trial 2023: EMPOWER Highlights & Side Effects. Trial Name: NCT05587517 — Phase 2

EMPOWER 2023 Treatment Timeline for Medical Study. Trial Name: NCT05587517 — Phase 2

~105 spots leftby Dec 2027

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