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

NCT ID: NCT07331324

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2030-12-31

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Coma Family Program 1

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

Group Type: EXPERIMENTAL

Coma Family Program 1

Intervention Type: BEHAVIORAL

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

Coma Family Program 2

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

Group Type: PLACEBO_COMPARATOR

Coma Family Program 2

Intervention Type: BEHAVIORAL

This involves education (but no skills training) 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.

Intervention Type: BEHAVIORAL

Coma Family Program 2

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Alexander Presciutti

Member of the Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Maryland School of Medicine

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of North Carolina School of Medicine

Chapel Hill, North Carolina, United States

Countries

United States

Central Contacts

Alexander M Presciutti, PhD

Role: CONTACT

apresciutti@mgh.harvard.edu

617 726 7913

Facility Contacts

Melissa Motta, MD

Role: primary

MMotta@som.umaryland.edu

410-328-4515

Alexander M Presciutti, PhD

Role: primary

apresciutti@mgh.harvard.edu

617 726 7913

David Hwang

Role: primary

David_Hwang@med.unc.edu

(919) 966-8178

Other Identifiers

2025P003235

Identifier Type: -

Identifier Source: org_study_id