About this trial

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.

Eligibility criteria

Qualifiers

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)

18 years or older - study population

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Coma Family Program 1
  • Coma Family Program 2

Treatment groups

150 Participants
are divided into 2 treatment groups

Locations

3
University of Maryland School of Medicine21201, BaltimoreMaryland, United States
Massachusetts General Hospital02114, BostonMassachusetts, United States
University of North Carolina School of Medicine27599, Chapel HillNorth Carolina, United States

Sponsors and collaborators

Massachusetts General Hospital

Lead sponsor