The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acu… (NCT07331324) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
United States150 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as 'not yet recruiting' — do you know when it's expected to open, and is there a way to get on a waitlist or be notified when enrollment begins?
2Since this program is designed for caregivers of patients with severe acute brain injury or coma, would you say our situation fits the kind of caregiving role this study is targeting, and is it worth discussing with the care team?
3The trial is measuring anxiety and depression using a standard scale — does that mean the program is mainly focused on the caregiver's mental health rather than the patient's medical treatment, and how would that fit alongside everything else we're already managing?
4Since this is listed as Phase NA, which often means it's a behavioral or supportive care study rather than a drug trial, what is actually known so far about whether resilience programs like this one help caregivers of brain injury patients, and are there similar programs already available to us?
5If we're interested in this study, what would participation actually look like day-to-day — for example, how much time would be required, and would any of it need to happen while the patient is still hospitalized?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hospital anxiety and depression scale
Timeframe: baseline, 6-weeks, and 3-month follow-up
. 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)