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

Primary Purpose

Coma, Emotional Distress

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COMA-F
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coma focused on measuring Severe Acute Brain Injury, Emotional Distress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hopsital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Preliminary feasibility of recruitment
We will assess the proportion of caregivers enrolled from the number of caregivers eligible.
Preliminary feasibility of assessments
We will assess the proportion of caregivers enrolled that completed all assessments.
Preliminary feasibility of adherence
We will assess the proportion of enrolled caregivers that complete 4 out of 6 sessions.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 27, 2023
Last Updated
October 6, 2023
Sponsor
Massachusetts General Hospital
Collaborators
University of North Carolina, Chapel Hill, University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT05761925
Brief Title
The COMA Family Program: A Skills-Based Resiliency Program for Caregivers of Patients With Severe Acute Brain Injuries
Acronym
COMA-F
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
University of North Carolina, Chapel Hill, University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coma, Emotional Distress
Keywords
Severe Acute Brain Injury, Emotional Distress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
COMA-F
Intervention Description
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 Outcome Measure Information:
Title
Preliminary feasibility of recruitment
Description
We will assess the proportion of caregivers enrolled from the number of caregivers eligible.
Time Frame
0 weeks
Title
Preliminary feasibility of assessments
Description
We will assess the proportion of caregivers enrolled that completed all assessments.
Time Frame
Change from pre-test (0 weeks) to post-test (6 weeks).
Title
Preliminary feasibility of adherence
Description
We will assess the proportion of enrolled caregivers that complete 4 out of 6 sessions.
Time Frame
Change from pre-test (0 weeks) to post-test (6 weeks).
Title
Preliminary feasibility of therapist fidelity
Description
We will assess the number of sessions in which the therapist adhered 100% to the treatment manual based on a fidelity checklist.
Time Frame
Change from pre-test (0 weeks) to post-test (6 weeks).
Title
Preliminary treatment satisfaction
Description
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.
Time Frame
post-test (6 weeks after session 1)
Title
Preliminary treatment credibility
Description
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.
Time Frame
post-test (6 weeks after session 1)
Other Pre-specified Outcome Measures:
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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).
Time Frame
Change from pre-test (0 weeks) to post-test (6 weeks)
Title
Posttraumatic Stress Disorder Checklist-5
Description
Post-Traumatic Stress Disorder Checklist - 5; range 0-80, higher scores indicate greater posttraumatic stress
Time Frame
Change from pre-test (0 weeks) to post-test (6 weeks)
Title
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
Description
Cognitive and Affective Mindfulness Scale-R (CAMS-R); 12-48, higher scores indicate greater perceived mindfulness
Time Frame
Change from pre-test (0 weeks) to post-test (6 weeks)
Title
Measure of Current Status Part A (MOCS-A)
Description
Measure of Current Status Part A (MOCS-A); 0-52; higher scores indicate greater perceived ability to cope
Time Frame
Change from pre-test (0 weeks) to post-test (6 weeks)
Title
Toronto Mindfulness Scale-Trait (TMS-Trait)
Description
Toronto Mindfulness Scale-Trait (TMS-Trait); 0-52, higher scores indicate greater perceived mindfulness (specifically curiosity and de-centering)
Time Frame
Change from pre-test (0 weeks) to post-test (6 weeks)
Title
Enhancing Recovery in Coronary Heart Disease Social Support Instrument (ESSI)
Description
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.
Time Frame
Change from pre-test (0 weeks) to post-test (6 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana-Maria Vranceanu, PhD
Phone
617-724-4977
Email
avranceanu@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Woodworth, BA
Phone
617-643-4123
Email
ewoodworth1@partners.org
Facility Information:
Facility Name
Massachusetts General Hopsital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana-Maria Vranceanu, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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