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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Massachusetts General Hospital
Study ID
NCT07331324
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Feb 2026
Primary completion
Aug 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Maryland School of MedicineBaltimoreMaryland21201
Melissa Motta, MD
[email protected]
410-328-4515
Massachusetts General HospitalBostonMassachusetts02114
Alexander M Presciutti, PhD
[email protected]
617 726 7913
University of North Carolina School of MedicineChapel HillNorth Carolina27599
David Hwang
[email protected]
(919) 966-8178

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University of Maryland School of Medicine· Baltimore, MDMassachusetts General Hospital· Boston, MAUniversity of North Carolina School of Medicine· Chapel Hill, NC

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