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

NCT ID: NCT05761925

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-16
• Study Completion Date: 2025-05-01

Brief 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.

Detailed 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.

Conditions

Coma; Emotional Distress

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

Caregivers will participate in 6 30-minute skills sessions. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills to reduce emotional distress and prevent chronic distress.

Group Type: EXPERIMENTAL

COMA-F

Intervention Type: BEHAVIORAL

The intervention will teach resiliency skills (mindfulness, coping, interpersonal communication, etc.) to the comatose patient's caregiver. These sessions will take place in person or on Zoom, depending on the participant's preference.

Interventions

COMA-F

The intervention will teach resiliency skills (mindfulness, coping, interpersonal communication, etc.) to the comatose patient's caregiver. These sessions will take place in person or on Zoom, depending on the participant's preference.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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 brain injury: i. Ischemic stroke ii. Intracerebral hemorrhage iii. Subarachnoid hemorrhage iv. Traumatic brain injury v. Hypoxic-ischemic encephalopathy; c. In the judgment of the medical team, has had a Glasgow Coma Scale score below 9 while not intubated OR an inability to following meaningful commands while intubated at any point during his or her hospitalization course for greater than 24 consecutive hours, felt to be due 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 team approaches the primary caregiver about possible recruitment; e. Has a prognosis for survival of greater than 3 months and does not have a concurrent diagnosis of a terminal illness or injury, as judged by the clinical team.

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 bipolar disorder, schizophrenia, or active substance use

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ana-Maria Vranceanu, PhD

Associate Professor/Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hopsital

Boston, Massachusetts, United States

Countries

United States

References

Presciutti AM, Rochon E, Alvarez-Frank N, Daily J, Silverman E, Motta M, Vranceanu AM, Hwang DY. Multisite Open Pilot Trial of a Resilience Intervention for Caregivers of Patients with Severe Acute Brain Injury: The Coma Family Program. Neurocrit Care. 2025 Sep 25. doi: 10.1007/s12028-025-02387-x. Online ahead of print.

Reference Type: DERIVED

PMID: 40999289 (View on PubMed)

Presciutti AM, Woodworth E, Rochon E, Neale M, Motta M, Piazza J, Vranceanu AM, Hwang DY. A Mindfulness-Based Resiliency Program for Caregivers of Patients With Severe Acute Brain Injury Transitioning Out of Critical Care: Protocol for an Open Pilot Trial. JMIR Res Protoc. 2023 Oct 25;12:e50860. doi: 10.2196/50860.

Reference Type: DERIVED

PMID: 37878376 (View on PubMed)

Other Identifiers

2021P000423

Identifier Type: -

Identifier Source: org_study_id