Federal Grant Award Summary

Case Western Reserve University received a $659,056 Project Grant award from the National Institute on Aging (Aging Research program, CFDA 93.866) effective June 1, 2026, through May 31, 2031, to conduct a randomized controlled trial evaluating REFRAME, a tablet-based emotion regulation intervention for surrogate decision-makers (SDMs) of critically ill patients. The research addresses a significant clinical gap, as more than three million adults aged 35 and older are admitted to intensive care units annually, with most SDMs unprepared for high-stakes treatment decisions and subsequently experiencing psychological distress, post-traumatic stress disorder (PTSD), and decision regret. REFRAME employs cognitive reappraisal theory through an interactive, self-directed platform incorporating psychoeducation, emotional assessments, guided strategy selection, and structured planning to help SDMs recognize, reinterpret, and regulate emotional responses during critical decision-making.

The project will enroll 387 SDMs in a two-arm parallel randomized controlled trial comparing REFRAME to an attention-matched informational support control condition, with standardized outcome measures assessed at baseline, 24-48 hours post-intervention, 24-48 hours post-first follow-up, and 90 days post-baseline. Primary research aims include evaluating REFRAME's effects on depressive symptoms and examining secondary outcomes of PTSD symptoms and decision regret, as well as analyzing mechanisms of intervention efficacy. The research is conducted at Case Western Reserve University's Cleveland, Ohio facility in affiliation with University Hospitals of Cleveland.