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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Injury; Coma; Emotional Distress; Resilience; Caregivers; Caregiver Distress
• Intervention / Treatment: Behavioral: Coma Family Program 1; Behavioral: Coma Family Program 2

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander M Presciutti, PhD; Phone Number: 617 726 7913; Email: apresciutti@mgh.harvard.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland School of Medicine
      • Contact: Melissa Motta, MD; Phone Number: 410-328-4515; Email: MMotta@som.umaryland.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
      • Contact: Alexander M Presciutti, PhD; Phone Number: 617 726 7913; Email: apresciutti@mgh.harvard.edu
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina School of Medicine
      • Contact: David Hwang; Phone Number: (919) 966-8178; Email: David_Hwang@med.unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18 years or older - study population
2. English fluency and literacy - measures and intervention are in English
3. 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)

4. 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:

   1. 18 years or older - study population
   2. Admitted with ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, traumatic brain injury, or hypoxic-ischemic encephalopathy - study population
   3. 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
   4. 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)
   5. 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
   6. 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
   7. 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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coma Family Program 1; This arm provides skills training to manage distress, uncertainty, and long-term caregiving challenges.	Behavioral: Coma Family Program 1; This intervention provides skills training to manage distress, uncertainty, and long-term caregiving challenges.
Placebo Comparator: Coma Family Program 2; This arm involves providing education about managing caregiving distress, uncertainty, and long-term challenges.	Behavioral: Coma Family Program 2; This involves education (but no skills training) about managing caregiving distress, uncertainty, and long-term challenges.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Posttraumatic stress disorder checklist-5	measures posttraumatic stress symptoms. Scores range from 0 (minimum) to 80 (maximum) with higher scores indicating worse outcome.	baseline, 6-weeks, and 3-month follow-up
World Health Organization Quality of Life-Short Form	Measures quality of life across four domains, physical, psychological, social, and environmental. Scores on each sub scale range from 0 (minimum) to 100 (maximum) with higher scores indicating better outcome.	baseline, 6-weeks, and 3-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive and Affective Mindfulness Scale	measures dispositional mindfulness. Scores range from 12 (minimum) to 48 (maximum), with higher scores indicating better outcome (greater dispositional mindfulness).	baseline, 6-weeks, and 3-month follow-up
Applied Mindfulness Process Scale	measures applied mindfulness. Scores range from 0 (minimum) to 60 (maximum) with higher scores indicating better outcome (more frequent application of mindfulness skills in daily life).	baseline, 6-weeks, and 3-month follow-up
Measure of Current Status-A	measures adaptive coping. Scores range from 0 (minimum) to 4 (maximum) with higher scores indicating better outcome (better use of adaptive coping skills).	baseline, 6-weeks, and 3-month follow-up
Intolerance of Uncertainty Scale Short Form	Measures intolerance of uncertainty. Scores range from 12 (minimum) to 60 (maximum) with higher scores indicating worse outcome (greater intolerance of uncertainty).	baseline, 6-weeks, and 3-month follow-up
Zarit Burden Interview Short Form	Measures caregiver burden. Scores range from 0 (minimum) to 48 (maximum) with higher scores indicating worse outcome (greater caregiver burden).	baseline, 6-weeks, and 3-month follow-up

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: caregiver burden; mindfulness; caregivers; resilience; coma; emotional distress; severe acute brain injury
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Behavioral Symptoms; Neurobehavioral Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Stress, Psychological; Consciousness Disorders; Unconsciousness; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Caregiver Burden; Brain Injuries; Coma
• Other Study ID Numbers: 2025P003235

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data includes caregiver demographic characteristics, health characteristics (quality of life), and outcome assessments (e.g., emotional distress, coping, mindfulness, etc). These measures will be self-reported. We will also collect limited quantitative data extracted from patients' medical charts (diagnosis, age, race, ethnicity). All data will be de-identified and preserved for at least seven years after closing the study with IRB. Quantitative datasets will be made available via the Vivli database.
• IPD Sharing Time Frame: All de-identified data will be preserved for at least seven years after closing the study with IRB.
• IPD Sharing Access Criteria: The de-identified quantitative dataset will be made freely available for requests that are ethically sound.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No