The Coma Family Program: a resilience program for caregivers of patients with severe brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study targets informal caregivers of patients with severe acute brain injury who are experiencing emotional distress. Participants are randomized to receive one of two versions of the Coma Family Program, or a health education control, with the aim of reducing depression and anxiety symptoms. The program focuses on building resilience and coping strategies for caregivers during the patient’s ICU hospitalization and recovery trajectory. Eligibility requires caregiver age 18+, English fluency, and elevated distress on the Hospital Anxiety and Depression Scale, with the patient meeting criteria for severe brain injury and ICU admission. The study is conducted across multiple sites including Maryland, Boston, and New York, with the Icahn School of Medicine at Mount Sinai leading the effort.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Maryland School of Medicine
  Baltimore, Maryland, United States Recruiting
• Mount Sinai Health System
  New York, New York, United States Recruiting
• University of North Carolina School of Medicine
  Chapel Hill, North Carolina, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Withdrawn

Study contacts

• Principal investigator: Alexander Presciutti, PhD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Alexander M Presciutti, PhD
• Email: alexander.presciutti@mountsinai.org
• Phone: 332-877-281

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.