ComaCOMA-FNCT05761925
The COMA Family Program: A Skills-Based Resiliency Program for Caregivers of Patients With Severe Acute Brain Injuries
A study testing COMA-F in people with Coma and Emotional Distress, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coma, Emotional Distress
- What is being tested?
- COMA-F
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Age 18 or older
- English-speaking
- Confirmed by the primary clinical team as the primary caregiver for a patient who:
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hopsital
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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
- Being tested
- COMA-F
- Keywords
- Severe Acute Brain Injury, Emotional Distress
- Medical subject headings
- Coma, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMA-FBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: COMA-F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preliminary feasibility of recruitment
We will assess the proportion of caregivers enrolled from the number of caregivers eligible.
Measured: 0 weeks
Preliminary feasibility of assessments
We will assess the proportion of caregivers enrolled that completed all assessments.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: post-test (6 weeks after session 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start16 Apr 2024
- Primary completion2 Jan 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ComaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, University of Maryland, Baltimore
- Responsible party
- Principal investigator, Ana-Maria Vranceanu, PhD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761925
- Sponsor's protocol ID
- 2021P000423
- Acronym
- COMA-F
- Status last verified
- May 2025
- First submitted
- 27 Feb 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2026 Apr;44(2):597-613. doi: 10.1007/s12028-025-02387-x. Epub 2025 Sep 25.
PubMed 40999289Presciutti 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.
PubMed 37878376
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The COMA Family Program: A Skills-Based Resiliency Program for Caregivers of Patients With Severe Acute Brain Injuries (COMA-F)
- ClinicalTrials.gov ID
- NCT05761925
- Acronym / sponsor ID
- COMA-F / 2021P000423
- Conditions
- Coma, Emotional Distress
- Keywords
- Severe Acute Brain Injury, Emotional Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, University of Maryland, Baltimore
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 2 Jan 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: COMA-FCaregivers 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- Age 18 or older
- English-speaking
- Confirmed by the primary clinical team as the primary caregiver for a patient who:
Key exclusion criteria (4 listed)
- Patient has terminal diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COMA-FThe 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. | Behavioural | Intervention |
Primary outcome
Preliminary feasibility of recruitment
Time frame: 0 weeks
We will assess the proportion of caregivers enrolled from the number of caregivers eligible.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Derived from this study: PubMed 40999289Presciutti 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. 2026 Apr;44(2):597-613. doi: 10.1007/s12028-025-02387-x. Epub 2025 Sep 25.
- Derived from this study: PubMed 37878376Presciutti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COMA-F in people with Coma and Emotional Distress, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preliminary feasibility of recruitment (time frame: 0 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05761925, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.