The COMA Family Program: A Skills-Based Resiliency Program for Caregivers of Patients With Severe Acute Brain Injuries

Last updated: May 21, 2025
Sponsor: Massachusetts General Hospital
Overall Status: Completed

Phase

N/A

Condition

Neurologic Disorders

Treatment

COMA-F

Clinical Study ID

NCT05761925
2021P000423
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to pilot a psychosocial skills-based intervention for caregivers of patients with severe acute brain injuries. The data the investigators gather in this study will be used to further refine our COMA-F intervention.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Eligible caregivers must be caregivers of patients considered to have severe acute brain injury and be unable to communicate with their loved one or clinical team due to their incapacitated nature. Caregivers must meet the following inclusion criteria:

  1. Age 18 or older

  2. English-speaking

  3. Confirmed by the primary clinical team as the primary caregiver for a patient who: a. Is age 18 or older; b. Has been admitted to the ICU with a severe acute braininjury: i. Ischemic stroke ii. Intracerebral hemorrhage iii. Subarachnoid hemorrhageiv. Traumatic brain injury v. Hypoxic-ischemic encephalopathy; c. In the judgment ofthe medical team, has had a Glasgow Coma Scale score below 9 while not intubated ORan inability to following meaningful commands while intubated at any point duringhis or her hospitalization course for greater than 24 consecutive hours, felt to bedue to the brain injury itself and not a confounding factor (i.e., sedation,seizures, etc.); d. Is still alive in the ICU at the time that the clinical teamapproaches the primary caregiver about possible recruitment; e. Has a prognosis forsurvival of greater than 3 months and does not have a concurrent diagnosis of aterminal illness or injury, as judged by the clinical team.

Exclusion

Exclusion Criteria: Patient has terminal diagnosis Caregiver has:

  • Lack of access to internet and/or a device with a camera

  • Current untreated or unstable severe mental health conditions like bipolardisorder, schizophrenia, or active substance use

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: COMA-F
Phase:
Study Start date:
April 16, 2024
Estimated Completion Date:
May 01, 2025

Study Description

The goal of this study is to refine our proposed intervention (COMA-F) through an open pilot. The investigators will deliver an open pilot of the intervention (N=15 caregivers) to evaluate initial feasibility and acceptability using exit interviews and pre-post assessments.

The open pilot will take place at the Massachusetts General Hospital, University of North Carolina School of Medicine, and University of Maryland School of Medicine neurological intensive care units (NICUs) or step-down units using our established methodology successfully implemented during our previous R21 of our Recovering Together study. Study clinicians will deliver 6, 30 minute sessions of the intervention (at bedside or on Zoom, depending on participant preference). All participants will complete measures at baseline, and after completion of program (6 weeks). They will also complete measures of emotional distress weekly. At the completion of the program, participants will engage in a 5-10 minute exit interview where they will provide feedback of the intervention.

Connect with a study center

  • Massachusetts General Hopsital

    Boston, Massachusetts 02114
    United States

    Site Not Available

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