The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury

NCT07331324 | Not Yet Recruiting DMC

• 1 other identifier: 2025P003235
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this research study is to determine whether COMA-F is more efficacious at reducing emotional distress in caregivers of patients with severe acute brain injuries, compared to health education control.

Conditions

Emotional Distress; Caregivers; Resilience; Coma; Brain Injury; Caregiver Distress

Keywords

caregivers; emotional distress; caregiver burden; resilience; coma; severe acute brain injury; mindfulness

Outcome Measures

Primary Outcomes (1)

• Hospital anxiety and depression scale

  Measures anxiety and depression. Anxiety and depression sub scales each range from 0 (minimum) to 21 (maximum) with higher scores meaning worse outcome.

  baseline, 6-weeks, and 3-month follow-up

Secondary Outcomes (2)

• Posttraumatic stress disorder checklist-5

  baseline, 6-weeks, and 3-month follow-up

• World Health Organization Quality of Life-Short Form

  baseline, 6-weeks, and 3-month follow-up

Other Outcomes (5)

• Cognitive and Affective Mindfulness Scale

  baseline, 6-weeks, and 3-month follow-up

• Applied Mindfulness Process Scale

  baseline, 6-weeks, and 3-month follow-up

• Measure of Current Status-A

  baseline, 6-weeks, and 3-month follow-up

Study Arms (2)

Coma Family Program 1

EXPERIMENTAL

This arm provides skills training to manage distress, uncertainty, and long-term caregiving challenges.

Behavioral: Coma Family Program 1

Coma Family Program 2

PLACEBO COMPARATOR

This arm involves providing education about managing caregiving distress, uncertainty, and long-term challenges.

Behavioral: Coma Family Program 2

Interventions

Coma Family Program 1 BEHAVIORAL

This intervention provides skills training to manage distress, uncertainty, and long-term caregiving challenges.

Coma Family Program 1

Coma Family Program 2 BEHAVIORAL

This involves education (but no skills training) about managing caregiving distress, uncertainty, and long-term challenges.

Coma Family Program 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older - study population
• English fluency and literacy - measures and intervention are in English
• Screens positive for emotional distress on either depression or anxiety subscales (\>7) of the Hospital Anxiety and Depression scale - study population (caregivers must be at-risk for chronic distress via heightened acute distress)
• Confirmed by the clinical team as the primary caregiver of a patient who has been admitted to an intensive care unit (ICU) with a severe acute brain injury with the following characteristics:
• years or older - study population
• Admitted with ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, traumatic brain injury, or hypoxic-ischemic encephalopathy - study population
• Glasgow Coma Scale score below 9 (in judgement of the clinical team) while not intubated or an inability to follow meaningful commands while intubated at any point during the hospitalization for \> 24 consecutive hours due to the brain injury itself and not a confounding factor (e.g., sedation or seizures) - study population
• Still alive in ICU at the time the clinical team approaches the caregiver about possible recruitment - excludes caregivers of those that passed away as would require a different intervention (e.g., grieving intervention)
• Has been committed to or has already received long-term life-sustaining treatments including tracheostomy and/or percutaneous endoscopic or surgical gastrostomy tube placement (trach or PEG) - study population; at time of enrollment patients can be in various early stages of cognitive/functional recovery from initial coma, but all were severe enough to require trach and/or PEG
• 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 - as in "d"; such caregivers would require different intervention
• Is still in ICU or has been transferred to a lower level of care (e.g., stepdown) for \<7 days at the time of consent - study population; we aim to begin the intervention when caregivers are acutely distressed in the context of the patient's ICU stay or shortly after the ICU stay (i.e., within 7 days of leaving)

You may not qualify if:

• \. Serious mental illness, substance misuse, or active suicidal intent or plan - requires higher level of care

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (3)

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of North Carolina School of Medicine

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Coma; Brain Injuries; Caregiver Burden

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

Alexander M Presciutti, PhD

CONTACT

617 726 7913; apresciutti@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Member of the Faculty

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 9, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: All de-identified data will be preserved for at least seven years after closing the study with IRB.
• Access Criteria: The de-identified quantitative dataset will be made freely available for requests that are ethically sound.

Locations

US (3)