Recruiting

COMA-F

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07331324

Conditions

Caregiver Distress

Emotional Distress

Caregivers

Resilience

Coma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Coma Family Program 1

Coma Family Program 2

Study Details

Brief summary:

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.

Conditions

Caregiver Distress

Emotional Distress

Caregivers

Resilience

Coma

Study ID

NCT07331324

Start date

Sep 28, 2026

Status verified date

Oct, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Aug, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Coma Family Program 1

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

placebo comparator: Coma Family Program 2

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

Interventions

Coma Family Program 1

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

Coma Family Program 2

This involves education (but no skills training) about managing caregiving distress, uncertainty, and long-term challenges.

Primary outcome measure

  • Hospital anxiety and depression scale [ Time Frame: baseline, 6-weeks, and 3-month follow-up ]

Central Contacts and Locations

Central contacts

Alexander M Presciutti, PhD

332-877-281alexander.presciutti@mountsinai.org

Georgia Cosola, MA

332-877-2814georgia.cosola@mountsinai.org

Locations

University of Maryland School of Medicine

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Melissa Motta, MD

410-328-4515MMotta@som.umaryland.edu

Mount Sinai Health System

Recruiting

New York, New York, United States, 10029

University of North Carolina School of Medicine

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

David Hwang

(919) 966-8178David_Hwang@med.unc.edu

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Oct 29, 2026

Last verified

Oct, 2026

Keywords

  • caregivers
  • emotional distress
  • caregiver burden
  • resilience
  • coma
  • severe acute brain injury
  • mindfulness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-30. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-10-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.