Caregiver DistressCOMA-FNCT07331324
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
A study testing Coma Family Program 1 and Coma Family Program 2 in people with Caregiver Distress and Emotional Distress, run by Massachusetts General Hospital at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Distress, Emotional Distress, Caregivers
- What is being tested?
- Coma Family Program 1 and Coma Family Program 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2026to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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:
- 18 years or older - study population
- Admitted with ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, traumatic brain injury, or hypoxic-ischemic encephalopathy - study population
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- 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)
Who cannot join
- 1. Serious mental illness, substance misuse, or active suicidal intent or plan - requires higher level of care
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Melissa Motta, MD, 410-328-4515, MMotta@som.umaryland.edu
Massachusetts General Hospital
Boston, Massachusetts, 02114
Alexander M Presciutti, PhD, 617 726 7913, apresciutti@mgh.harvard.edu
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599
David Hwang, (919) 966-8178, David_Hwang@med.unc.edu
About this study
Official title: 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.
- Conditions
- Caregiver Distress, Emotional Distress, Caregivers, Resilience, Coma, Brain Injury
- Being tested
- Coma Family Program 1, Coma Family Program 2
- Keywords
- caregivers, emotional distress, caregiver burden, resilience, coma, severe acute brain injury, mindfulness
- Medical subject headings
- Coma, Brain Injuries, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coma Family Program 1Behavioural
This intervention provides skills training to manage distress, uncertainty, and long-term caregiving challenges.
Coma Family Program 2Behavioural
This involves education (but no skills training) about managing caregiving distress, uncertainty, and long-term challenges.
| Study group | Role | What they receive |
|---|---|---|
| Coma Family Program 1 | Experimental | This arm provides skills training to manage distress, uncertainty, and long-term caregiving challenges. Receives: 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. Receives: Behavioral: Coma Family Program 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 6-weeks, and 3-month follow-up
Secondary outcomes (2)
Posttraumatic stress disorder checklist-5
measures posttraumatic stress symptoms. Scores range from 0 (minimum) to 80 (maximum) with higher scores indicating worse outcome.
Measured: 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.
Measured: baseline, 6-weeks, and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study startMay 2026 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver DistressStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Presciutti, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331324
- Sponsor's protocol ID
- 2025P003235
- Acronym
- COMA-F
- Status last verified
- Feb 2026
- First submitted
- 16 Dec 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Coma Family Program (COMA-F): A Multi-site Clinical Trial of a Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
- ClinicalTrials.gov ID
- NCT07331324
- Acronym / sponsor ID
- COMA-F / 2025P003235
- Conditions
- Caregiver Distress, Emotional Distress, Caregivers, Resilience, Coma, Brain Injury
- Keywords
- caregivers, emotional distress, caregiver burden, resilience, coma, severe acute brain injury, mindfulness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coma Family Program 1 | Experimental | Behavioral: Coma Family Program 1This arm provides skills training to manage distress, uncertainty, and long-term caregiving challenges. |
| Coma Family Program 2 | Placebo comparator | Behavioral: Coma Family Program 2This arm involves providing education about managing caregiving distress, uncertainty, and long-term challenges. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 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:
Key exclusion criteria (1 listed)
- 1. Serious mental illness, substance misuse, or active suicidal intent or plan - requires higher level of care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coma Family Program 1This intervention provides skills training to manage distress, uncertainty, and long-term caregiving challenges. | Behavioural | Coma Family Program 1 |
| Coma Family Program 2This involves education (but no skills training) about managing caregiving distress, uncertainty, and long-term challenges. | Behavioural | Coma Family Program 2 |
Primary outcome
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.
2 secondary outcomes
Posttraumatic stress disorder checklist-5
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coma Family Program 1 and Coma Family Program 2 in people with Caregiver Distress and Emotional Distress, run by Massachusetts General Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander M Presciutti, PhD (617 726 7913, apresciutti@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital anxiety and depression scale (time frame: baseline, 6-weeks, and 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.