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

NCT05761925 | Completed DMC

• 1 other identifier: 2021P000423
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coma; Emotional Distress

Keywords

Severe Acute Brain Injury; Emotional Distress

Outcome Measures

Primary Outcomes (6)

• Preliminary feasibility of recruitment

  We will assess the proportion of caregivers enrolled from the number of caregivers eligible.

  0 weeks

• Preliminary feasibility of assessments

  We will assess the proportion of caregivers enrolled that completed all assessments.

  Change from pre-test (0 weeks) to post-test (6 weeks).

• Preliminary feasibility of adherence

  We will assess the proportion of enrolled caregivers that complete 4 out of 6 sessions.

  Change from pre-test (0 weeks) to post-test (6 weeks).

• Preliminary feasibility of therapist fidelity

  We will assess the number of sessions in which the therapist adhered 100% to the treatment manual based on a fidelity checklist.

  Change from pre-test (0 weeks) to post-test (6 weeks).

• Preliminary treatment satisfaction

  We will assess the proportion of enrolled caregivers that score above the midpoint on the Client Satisfaction Questionnaire-3. Scores range from 3 to 12; higher values indicate greater satisfaction.

  post-test (6 weeks after session 1)

• Preliminary treatment credibility

  We will use the Credibility and Expectancy Questionnaire (CEQ) to assesses caregivers perceptions that the treatment will work after learning about the study. Scores range from 3-27; higher ratings indicate more belief that the program is logical and will help with the intended outcome.

  post-test (6 weeks after session 1)

Other Outcomes (6)

• Hospital Anxiety and Depression Scale (HADS)

  Change from pre-test (0 weeks) to post-test (6 weeks)

• Posttraumatic Stress Disorder Checklist-5

  Change from pre-test (0 weeks) to post-test (6 weeks)

• Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)

  Change from pre-test (0 weeks) to post-test (6 weeks)

Study Arms (1)

Intervention

EXPERIMENTAL

Caregivers will participate in 6 30-minute skills sessions. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills to reduce emotional distress and prevent chronic distress.

Behavioral: COMA-F

Interventions

COMA-F BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• English-speaking
• Confirmed by the primary clinical team as the primary caregiver for a patient who:
• a. Is age 18 or older; b. Has been admitted to the ICU with a severe acute brain injury: i. Ischemic stroke ii. Intracerebral hemorrhage iii. Subarachnoid hemorrhage iv. Traumatic brain injury v. Hypoxic-ischemic encephalopathy; c. In the judgment of the medical team, has had a Glasgow Coma Scale score below 9 while not intubated OR an inability to following meaningful commands while intubated at any point during his or her hospitalization course for greater than 24 consecutive hours, felt to be due to the brain injury itself and not a confounding factor (i.e., sedation, seizures, etc.); d. Is still alive in the ICU at the time that the clinical team approaches the primary caregiver about possible recruitment; e. 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.

You may not qualify if:

• Patient has terminal diagnosis
• Caregiver has:
• Lack of access to internet and/or a device with a camera
• Current untreated or unstable severe mental health conditions like bipolar disorder, schizophrenia, or active substance use

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• University of North Carolina, Chapel Hill: collaborator
• University of Maryland, Baltimore: collaborator

Study Sites (1)

Massachusetts General Hopsital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• Presciutti AM, Rochon E, Alvarez-Frank N, Daily J, Silverman E, Motta M, Vranceanu AM, Hwang DY. Multisite Open Pilot Trial of a Resilience Intervention for Caregivers of Patients with Severe Acute Brain Injury: The Coma Family Program. Neurocrit Care. 2025 Sep 25. doi: 10.1007/s12028-025-02387-x. Online ahead of print.

  PMID: 40999289 DERIVED

• Presciutti AM, Woodworth E, Rochon E, Neale M, Motta M, Piazza J, Vranceanu AM, Hwang DY. A Mindfulness-Based Resiliency Program for Caregivers of Patients With Severe Acute Brain Injury Transitioning Out of Critical Care: Protocol for an Open Pilot Trial. JMIR Res Protoc. 2023 Oct 25;12:e50860. doi: 10.2196/50860.

  PMID: 37878376 DERIVED

MeSH Terms

Conditions

Coma; Brain Injuries

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor/Director

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 9, 2023
• Study Start: April 16, 2024
• Primary Completion: January 2, 2025
• Study Completion: May 1, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)