COMA-F Program for Caregivers of Patients with Severe Acute Brain Injury

This study, called COMA-F, is for caregivers of people with severe acute brain injuries who are experiencing emotional distress. It aims to see if two different versions of a behavioral program, Coma Family Program 1 (which includes skills training) or Coma Family Program 2 (which provides education), can help reduce anxiety and depression more effectively than standard health education. You might be able to join if you are 18 or older, speak English, and show signs of emotional distress on a specific screening test. The study plans to enroll 150 caregivers to understand which approach best supports their well-being. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 150 participants. It compares two behavioral programs against a health education control.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your anxiety and depression levels will be measured at the start, after 6 weeks, and again at 3 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07331324

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

Not Yet Recruiting
NAAges 18+InterventionalTreatment
Massachusetts General Hospital
~150 participants
Updated 2026-02-20 on ClinicalTrials.gov
What's tested:Coma Family Program 1Coma Family Program 2

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hospital anxiety and depression scale
Measured over baseline, 6-weeks, and 3-month follow-up
Caregiver Distress
Emotional Distress
Caregivers
Resilience
Coma
Brain Injury
3 sites across 3 states
Maryland1
Massachusetts1
North Carolina1

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

1\. Serious mental illness, substance misuse, or active suicidal intent or plan - requires higher level of care
  • Hospital anxiety and depression scalebaseline, 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.