The COMA Family Program: A Skills-Based Resiliency Program for Caregivers of Patients With Severe Acute Brain Injuries - Clinical Trial for Coma | NCT05761925

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

COMA-F

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

NCT ID

NCT05761925

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

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