Clinical trial NCT05761925: The COMA Family Program: A Skills-Based Resiliency Program for Caregivers of Patients With Severe Acute Brain Injuries
Official title: The COMA Family Program: A Skills-Based Resiliency Program for Caregivers of Patients With Severe Acute Brain Injuries (COMA-F)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coma
Emotional Distress
Keywords: Severe Acute Brain Injury
Emotional Distress
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: University of Maryland, Baltimore
First posted: 2023-03-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Preliminary feasibility of recruitment
timeFrame: 0 weeks
measure: Preliminary feasibility of assessments
timeFrame: Change from pre-test (0 weeks) to post-test (6 weeks).
measure: Preliminary feasibility of adherence
timeFrame: Change from pre-test (0 weeks) to post-test (6 weeks).
measure: Preliminary feasibility of therapist fidelity
timeFrame: Change from pre-test (0 weeks) to post-test (6 weeks).
measure: Preliminary treatment satisfaction
timeFrame: post-test (6 weeks after session 1)
measure: Preliminary treatment credibility
timeFrame: post-test (6 weeks after session 1)
Secondary outcomes:
Other outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from pre-test (0 weeks) to post-test (6 weeks)
measure: Posttraumatic Stress Disorder Checklist-5
timeFrame: Change from pre-test (0 weeks) to post-test (6 weeks)
measure: Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
timeFrame: Change from pre-test (0 weeks) to post-test (6 weeks)
measure: Measure of Current Status Part A (MOCS-A)
timeFrame: Change from pre-test (0 weeks) to post-test (6 weeks)
measure: Toronto Mindfulness Scale-Trait (TMS-Trait)
timeFrame: Change from pre-test (0 weeks) to post-test (6 weeks)
measure: Enhancing Recovery in Coronary Heart Disease Social Support Instrument (ESSI)
timeFrame: Change from pre-test (0 weeks) to post-test (6 weeks)
Locations:
city: Boston
country: United States
facility: Massachusetts General Hopsital
state: Massachusetts
Study officials:
References: