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

Mass General Brigham

Status: Begins enrollment in 1 month

Conditions: Coma; Resilience; Brain Injury; Emotional Distress; Caregiver Distress; Caregivers

Treatments: Behavioral: Coma Family Program 1; Behavioral: Coma Family Program 2

Study type: Interventional

Funder types: Other

Identifiers

NCT07331324

2025P003235

Details and patient eligibility

About

The purpose of this research study is to see if two different psychosocial programs for caregivers of patients with severe acute brain injuries are able to improve caregiver mental health.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups, including a placebo group

Coma Family Program 1

Experimental group

Description:

This arm provides skills training to manage distress, uncertainty, and long-term caregiving challenges.

Treatment:

Behavioral: Coma Family Program 1

Coma Family Program 2

Placebo Comparator group

Description:

This arm involves providing education about managing caregiving distress, uncertainty, and long-term challenges.

Treatment:

Behavioral: Coma Family Program 2