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

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

Recruiting
18 years and older
All
Phase N/A

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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.

Eligibility

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:

• Serious mental illness, substance misuse, or active suicidal intent or plan - requires higher level of care

Study details
    Caregiver Distress
    Emotional Distress
    Caregivers
    Resilience
    Coma
    Brain Injury

NCT07331324

Icahn School of Medicine at Mount Sinai

31 October 2026

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