JMIR Publications

ABSTRACT

Background:

Caregivers of patients with severe acute brain injuries (SABIs) that lead to coma and require intensive care unit (ICU) treatment often experience chronic emotional distress. To address this need, we interviewed caregivers of SABI patients to inform development of the Coma Family Program (COMA-F), a mindfulness-based resiliency intervention for these caregivers.

Objective:

We will conduct an open pilot trial of COMA-F (NIH Stage 1a). Here we describe our study protocol, proposed intervention content, study design, and future directions.

Methods:

Overview: Consistent with guidelines for NIH Stage 1A research, we will enroll 15 caregivers of patients with SABIs during their loved one’s hospital course. A clinical psychologist will deliver the COMA-F intervention (6 sessions). Sessions will be offered to be done entirely over Zoom or in person. We will iterate COMA-F after each caregiver completes the intervention and an exit interview. Eligibility: English-speaking adults with emotional distress and confirmed by primary clinical team as the primary caregiver of a SABI patient. The patient must 1) be an adult, 2) have been admitted to the Neuro-ICU for SABI, 3) have had a Glasgow Coma Scale score below 9 while not intubated OR an inability to follow meaningful commands while intubated at any point during their hospitalization for >24 consecutive hours due to SABI and not a confounding factor, 4) be alive in the ICU when the clinical team approaches the primary caregiver about recruitment, 5) either will be undergoing tracheostomy and/or percutaneous endoscopic/surgical gastrostomy tube placement, or has already received one/both, and 6) have a prognosis of survival >3 months and does not have a concurrent diagnosis of a terminal illness or injury as judged by the clinical team. Enrollment: We will identify caregivers through screening patients’ medical records and direct referrals from clinicians in the Neuro-ICU. Outcomes: After consent, caregivers will complete self-report assessments (measures of emotional distress and resilience) before and after the intervention. Consistent with NIH Stage 1a recommendations, primary outcomes are feasibility (recruitment, quantitative measures, adherence, therapist fidelity) and acceptability (treatment satisfaction, credibility, and expectancy). At the end of the intervention, we will conduct brief qualitative exit interviews to gather feedback to further improve the program and study procedures. Analysis: We will use frequencies and proportions to determine feasibility and acceptability and will analyze qualitative exit interview data using thematic analysis. We will also conduct t-tests to explore signal of improvement in emotional distress and treatment targets. We will then conduct mixed methods analysis using an explanatory-sequential design, which will allow us to integrate quantitative and qualitative data to refine the COMA-F manual and study procedures.

Results:

We will begin recruiting participants in July 2023.

Conclusions:

We will use our findings to refine the COMA-F intervention and prepare for a feasibility randomized controlled trial. Clinical Trial: ClinicalTrials.gov Identifier #: NCT05761925