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

February 18, 2026 updated by: Alexander Presciutti, Massachusetts General Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland School of Medicine
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hospital anxiety and depression scale
Time Frame: baseline, 6-weeks, and 3-month follow-up
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Posttraumatic stress disorder checklist-5
Time Frame: baseline, 6-weeks, and 3-month follow-up
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
Time Frame: baseline, 6-weeks, and 3-month follow-up
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cognitive and Affective Mindfulness Scale
Time Frame: baseline, 6-weeks, and 3-month follow-up
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
Time Frame: baseline, 6-weeks, and 3-month follow-up
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
Time Frame: baseline, 6-weeks, and 3-month follow-up
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
Time Frame: baseline, 6-weeks, and 3-month follow-up
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
Time Frame: baseline, 6-weeks, and 3-month follow-up
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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