A Mindfulness-Based Resiliency Program for Caregivers of Patients With Severe Acute Brain Injury Transitioning Out of Critical Care: Protocol for an Open Pilot Trial (Preprint)

• DOI: 10.2196/preprints.50860
• Publication Date: 2023-10-25T12:45:40Z
• Authors: Alexander Mattia ...; Emily Woodworth; Elizabeth Rochon; Molly Neale; Melissa Motta; Joseph Piazza; Ana-Maria Vranceanu; David Yi-Gin Hwang
• Keywords: Coma (optics)

<sec> <title>BACKGROUND</title> Caregivers of patients with severe acute brain injuries (SABI) that lead to coma and require intensive care unit (ICU) treatment often experience chronic emotional distress. To address this need, we developed the Coma Family (COMA-F) program, a mindfulness-based resiliency intervention for these caregivers. </sec> <title>OBJECTIVE</title> We will conduct an open pilot trial COMA-F (National Institutes Health Stage IA). Here describe our study protocol proposed content. <title>METHODS</title> enroll 15 caregivers SABIs during their loved one’s hospital course from 3 enrollment centers. A clinical psychologist deliver (6 sessions) over Zoom (Zoom Video Communications, Inc) or in person. iterate after each caregiver completes exit interview. English-speaking adults who have distress confirmed by team are primary patient SABI eligible. The adult must been admitted neuro-ICU (1) had Glasgow Scale score below 9 while not intubated inability follow meaningful commands at any point hospitalization &amp;gt;24 hours due SABI; (2) be undergoing either tracheostomy percutaneous endoscopic surgical gastrostomy tube placement already received one both; (3) prognosis survival &amp;gt;3 months. identify eligible through screening patients’ medical records direct referrals clinicians neuro-ICU. During teach mind-body resilience skills, including deep breathing, mindfulness, meditation, dialectical thinking, acceptance, cognitive restructuring, effective communication, behavioral activation, meaning-making&lt;i&gt;.&lt;/i&gt; complete self-report assessments (measures resilience) before intervention. Primary outcomes feasibility (recruitment, quantitative measures, adherence, therapist fidelity) acceptability (treatment satisfaction, credibility, expectancy). brief qualitative interviews gather feedback on refining program procedures. examine frequencies proportions determine analyze interview data using thematic analysis. also 2-tailed &lt;i&gt;t&lt;/i&gt; tests explore signals improvement targets. then explanatory-sequential mixed methods analysis integrate refine manual <title>RESULTS</title> This has approved institutional review board 1 centers (2023P000536), approvals other 2 pending. anticipate completed late 2024. <title>CONCLUSIONS</title> use findings prepare randomized controlled trial. <title>CLINICALTRIAL</title> ClinicalTrials.gov NCT05761925; https://clinicaltrials.gov/study/NCT05761925 <title>INTERNATIONAL REGISTERED REPORT</title> PRR1-10.2196/50860