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NCT Number: NCT07331324

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland School of Medicine, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Coma Family Program 1

Behavioral

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

Coma Family Program 2

Behavioral

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

Primary outcomes

  1. Hospital anxiety and depression scale

    Time frame: baseline, 6-weeks, and 3-month follow-up

    Measures anxiety and depression. Anxiety and depression sub scales each range from 0 (minimum) to 21 (maximum) with higher scores meaning worse outcome.

Secondary outcomes

  1. Posttraumatic stress disorder checklist-5

    Time frame: baseline, 6-weeks, and 3-month follow-up

    measures posttraumatic stress symptoms. Scores range from 0 (minimum) to 80 (maximum) with higher scores indicating worse outcome.

  2. World Health Organization Quality of Life-Short Form

    Time frame: baseline, 6-weeks, and 3-month follow-up

    Measures quality of life across four domains, physical, psychological, social, and environmental. Scores on each sub scale range from 0 (minimum) to 100 (maximum) with higher scores indicating better outcome.

Other outcomes

  1. Cognitive and Affective Mindfulness Scale

    Time frame: baseline, 6-weeks, and 3-month follow-up

    measures dispositional mindfulness. Scores range from 12 (minimum) to 48 (maximum), with higher scores indicating better outcome (greater dispositional mindfulness).

  2. Applied Mindfulness Process Scale

    Time frame: baseline, 6-weeks, and 3-month follow-up

    measures applied mindfulness. Scores range from 0 (minimum) to 60 (maximum) with higher scores indicating better outcome (more frequent application of mindfulness skills in daily life).

  3. Measure of Current Status-A

    Time frame: baseline, 6-weeks, and 3-month follow-up

    measures adaptive coping. Scores range from 0 (minimum) to 4 (maximum) with higher scores indicating better outcome (better use of adaptive coping skills).

  4. Intolerance of Uncertainty Scale Short Form

    Time frame: baseline, 6-weeks, and 3-month follow-up

    Measures intolerance of uncertainty. Scores range from 12 (minimum) to 60 (maximum) with higher scores indicating worse outcome (greater intolerance of uncertainty).

  5. Zarit Burden Interview Short Form

    Time frame: baseline, 6-weeks, and 3-month follow-up

    Measures caregiver burden. Scores range from 0 (minimum) to 48 (maximum) with higher scores indicating worse outcome (greater caregiver burden).

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander M Presciutti, PhD

CONTACT

[email protected]

617 726 7913

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Acronym: COMA-F

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jan 9, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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