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

May 21, 2025 updated by: Ana-Maria Vranceanu, PhD, Massachusetts General Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hopsital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Eligible caregivers must be caregivers of patients considered to have severe acute brain injury and be unable to communicate with their loved one or clinical team due to their incapacitated nature. Caregivers must meet the following inclusion criteria:

  1. Age 18 or older
  2. English-speaking

  3. 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.

    Exclusion Criteria:

    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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Preliminary feasibility of recruitment
Time Frame: 0 weeks
We will assess the proportion of caregivers enrolled from the number of caregivers eligible.
0 weeks
Preliminary feasibility of assessments
Time Frame: Change from pre-test (0 weeks) to post-test (6 weeks).
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
Time Frame: Change from pre-test (0 weeks) to post-test (6 weeks).
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
Time Frame: Change from pre-test (0 weeks) to post-test (6 weeks).
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
Time Frame: post-test (6 weeks after session 1)
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
Time Frame: post-test (6 weeks after session 1)
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 Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Change from pre-test (0 weeks) to post-test (6 weeks)
We will use the Hospital Anxiety and Depression Scale HADS, a 14-item measure that assesses symptoms of emotional distress (anxiety and depression). The anxiety and depression sub-scale are each scored from 0-21, with higher scores indicating greater severity of symptoms. Scores can be summed to create a global emotional distress score (0-42).
Change from pre-test (0 weeks) to post-test (6 weeks)
Posttraumatic Stress Disorder Checklist-5
Time Frame: Change from pre-test (0 weeks) to post-test (6 weeks)
Post-Traumatic Stress Disorder Checklist - 5; range 0-80, higher scores indicate greater posttraumatic stress
Change from pre-test (0 weeks) to post-test (6 weeks)
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
Time Frame: Change from pre-test (0 weeks) to post-test (6 weeks)
Cognitive and Affective Mindfulness Scale-R (CAMS-R); 12-48, higher scores indicate greater perceived mindfulness
Change from pre-test (0 weeks) to post-test (6 weeks)
Measure of Current Status Part A (MOCS-A)
Time Frame: Change from pre-test (0 weeks) to post-test (6 weeks)
Measure of Current Status Part A (MOCS-A); 0-52; higher scores indicate greater perceived ability to cope
Change from pre-test (0 weeks) to post-test (6 weeks)
Toronto Mindfulness Scale-Trait (TMS-Trait)
Time Frame: Change from pre-test (0 weeks) to post-test (6 weeks)
Toronto Mindfulness Scale-Trait (TMS-Trait); 0-52, higher scores indicate greater perceived mindfulness (specifically curiosity and de-centering)
Change from pre-test (0 weeks) to post-test (6 weeks)
Enhancing Recovery in Coronary Heart Disease Social Support Instrument (ESSI)
Time Frame: Change from pre-test (0 weeks) to post-test (6 weeks)
Enhancing Recovery in Coronary Heart Disease Social Support Instrument (ESSI); the ESSI measures the participant's range of social support in their life. Higher scores indicated higher levels of social support. Total scores range from 8 to 34.
Change from pre-test (0 weeks) to post-test (6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Maryland, Baltimore
University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 2, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021P000423

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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