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

Coma Clinical Trial

— COMA-F  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05761925
• Other study ID #: 2021P000423
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: February 2025

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: Ana-Maria Vranceanu, PhD
• Phone: 617-724-4977
• Email: avranceanu[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Coma
• Emotional Distress

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hopsital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	University of Maryland, Baltimore, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospital Anxiety and Depression Scale (HADS)	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)
Other	Posttraumatic Stress Disorder Checklist-5	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)
Other	Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)	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)
Other	Measure of Current Status Part A (MOCS-A)	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)
Other	Toronto Mindfulness Scale-Trait (TMS-Trait)	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)
Other	Enhancing Recovery in Coronary Heart Disease Social Support Instrument (ESSI)	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)
Primary	Preliminary feasibility of recruitment	We will assess the proportion of caregivers enrolled from the number of caregivers eligible.	0 weeks
Primary	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).
Primary	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).
Primary	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).
Primary	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)
Primary	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)