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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
20
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.
Massachusetts General Hopsital
Boston, Massachusetts, United States
Preliminary feasibility of recruitment
We will assess the proportion of caregivers enrolled from the number of caregivers eligible.
Time frame: 0 weeks
Preliminary feasibility of assessments
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).
Preliminary feasibility of adherence
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).
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.
Time frame: 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.
Time frame: 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.
Time frame: post-test (6 weeks after session 1)
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