NCT05761925

The COMA Family Program: A Skills-Based Resiliency Program for Caregivers of Patients With Severe Acute Brain Injuries

The COMA Family Program: A Skills-Based Resiliency Program for Caregivers of Patients With Severe Acute Brain Injuries (COMA-F)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to pilot a psychosocial skills-based intervention for caregivers of patients with severe acute brain injuries. The data the investigators gather in this study will be used to further refine our COMA-F intervention.

Detailed description

The goal of this study is to refine our proposed intervention (COMA-F) through an open pilot. The investigators will deliver an open pilot of the intervention (N=15 caregivers) to evaluate initial feasibility and acceptability using exit interviews and pre-post assessments. The open pilot will take place at the Massachusetts General Hospital, University of North Carolina School of Medicine, and University of Maryland School of Medicine neurological intensive care units (NICUs) or step-down units using our established methodology successfully implemented during our previous R21 of our Recovering Together study. Study clinicians will deliver 6, 30 minute sessions of the intervention (at bedside or on Zoom, depending on participant preference). All participants will complete measures at baseline, and after completion of program (6 weeks). They will also complete measures of emotional distress weekly. At the completion of the program, participants will engage in a 5-10 minute exit interview where they will provide feedback of the intervention.

Conditions

• Coma
• Emotional Distress

Interventions

Type	Name	Description
BEHAVIORAL	COMA-F	The intervention will teach resiliency skills (mindfulness, coping, interpersonal communication, etc.) to the comatose patient's caregiver. These sessions will take place in person or on Zoom, depending on the participant's preference.

Timeline

• Start date: 2024-04-16
• Primary completion: 2025-01-02
• Completion: 2025-05-01
• First posted: 2023-03-09
• Last updated: 2025-05-25

Locations

1 site across 1 country: United States