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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coma, Emotional Distress

Intervention / Treatment
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* Behavioral: COMA-F


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe Acute Brain Injury, Emotional Distress