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Completed

NCT Number: NCT05761925

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hopsital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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.

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

Treatment and study plan

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.

Primary outcomes

  1. Preliminary feasibility of recruitment

    Time frame: 0 weeks

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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Other outcomes

  1. 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).

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • University of Maryland, Baltimore
  • University of North Carolina, Chapel Hill

Registry information

Official study title

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

Acronym: COMA-F

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 9, 2023
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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