Multisite Open Pilot Trial of a Resilience Intervention for Caregivers of Patients with Severe Acute Brain Injury: The Coma Family Program.

Background: Family caregivers of patients with severe acute brain injury (SABI) often experience chronic emotional distress and lack evidence-based psychosocial treatments. To address this problem, we followed the National Institutes of Health (NIH) Stage Model to develop and pilot the Coma Family Program (COMA-F), a resilience intervention for caregivers of patients with SABI.

Methods: We conducted a single-arm open pilot clinical trial of COMA-F between February 2024 and February 2025 at three geographically diverse hospitals to test preliminary feasibility and acceptability and to refine the intervention prior to a larger randomized controlled trial (RCT) (NIH stage 1a). Caregivers endorsed elevated distress on the Hospital Anxiety and Depression Scale (HADS), and patients suffered coma for ≥ 24 hours and were committed to tracheostomy and/or gastrostomy. COMA-F involved six sessions focused on building mindfulness and coping skills for managing distress. Primary outcomes were: feasibility of recruitment, feasibility of assessments, adherence, therapist fidelity, satisfaction, credibility, and expectancy. Caregivers completed pretest and posttest measures of distress (HADS) and treatment mechanisms (dispositional mindfulness [Cognitive and Affective Mindfulness Scale-Revised], applied mindfulness [Applied Mindfulness Process Scale], coping [Measure of Current Status A]) and exit interviews to provide feedback. We calculated frequencies and proportions of feasibility and acceptability metrics, examined pretest and posttest changes on quantitative measures, and performed explanatory-sequential mixed methods to integrate the quantitative and qualitative data.

Results: We screened 36 caregivers and enrolled 20. COMA-F exceeded feasibility and acceptability benchmarks (≥ 70% on all) and showed improvements in emotional distress, dispositional mindfulness, and coping, with large effect sizes (Cohen's d = 0.8-1.95, p < 0.01). Mixed methods confirmed feasibility, acceptability, and utility of program skills in improving distress.

Conclusions: Results support preliminary feasibility and acceptability of COMA-F and further testing in a larger RCT (NIH stage 2).

Trial registration information: ClinicalTrials.gov #NCT05761925; first submitted February 27, 2023; first caregiver enrolled April 16, 2024.