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

NCT07331324 — Not applicable, Not yet recruiting, 150 participants, Massachusetts General Hospital

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

RegistryNCT07331324, acronym COMA-F
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment150 (Estimated)
SponsorMassachusetts General Hospital (Other)
ConditionsCaregiver Distress, Emotional Distress, Caregivers, Resilience, Coma, Brain Injury
InterventionsComa Family Program 1, Coma Family Program 2 (Behavioral)
Datesstart 2026-05-01 (estimated), primary completion 2030-08-01 (estimated), completion 2030-12-01 (estimated), first posted 2026-01-09, last updated 2026-02-20
Locations3 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Caregiver Distress All trials for Emotional Distress All trials of Coma Family Program 1 All trials of Coma Family Program 2

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Coma Family Program 1ExperimentalBehavioral: Coma Family Program 1This arm provides skills training to manage distress, uncertainty, and long-term caregiving challenges.
Coma Family Program 2Placebo comparatorBehavioral: Coma Family Program 2This arm involves providing education about managing caregiving distress, uncertainty, and long-term challenges.
  • 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.

+Outcome measures

Primary outcomes

  • Hospital anxiety and depression scale [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

  • Posttraumatic stress disorder checklist-5 [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.
  • World Health Organization Quality of Life-Short Form [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

  • Cognitive and Affective Mindfulness Scale [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).
  • Applied Mindfulness Process Scale [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).
  • Measure of Current Status-A [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).
  • Intolerance of Uncertainty Scale Short Form [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).
  • Zarit Burden Interview Short Form [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).

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (3)

FacilityCityCountryStatus
University of Maryland School of MedicineBaltimore, MarylandUnited States
Massachusetts General HospitalBoston, MassachusettsUnited States
University of North Carolina School of MedicineChapel Hill, North CarolinaUnited States