Not yet recruiting NCT07331324
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coma Family Program 1, Coma Family Program 2.
- Who it may be relevant to
- Registry conditions: Caregiver Distress, Emotional Distress, Caregivers, Resilience. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Behavioral Coma Family Program 1
This intervention provides skills training to manage distress, uncertainty, and long-term caregiving challenges. - Behavioral Coma Family Program 2
This involves education (but no skills training) about managing caregiving distress, uncertainty, and long-term challenges.
Primary outcome measures
- Hospital anxiety and depression scale [Time frame: baseline, 6-weeks, and 3-month follow-up]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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
- 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)
Exclusion criteria
- 1\. Serious mental illness, substance misuse, or active suicidal intent or plan - requires higher level of care
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- University of Maryland School of Medicine — Baltimore
- Massachusetts General Hospital — Boston
- University of North Carolina School of Medicine — Chapel Hill
Identifiers
NCT: NCT07331324 · 2025P003235