A Randomized Trial of REFRAME: an Emotion Regulation Intervention to Improve Psychological Outcomes in Surrogate Decision-Makers of the Critically Ill

/Abstract Each year, more than three million adults aged 35 and older are admitted to intensive care units (ICUs) in the United States. Most require a surrogate decision-maker (SDM) to make timely, emotionally charged treatment decisions. Often unprepared for this responsibility, SDMs frequently experience significant psychological distress that can impair their ability to make informed, value-congruent decisions. Long-term psychological consequences, such as post-traumatic stress disorder (PTSD) and decision regret, often follow these acute effects. Despite decades of research, few evidence-based and scalable interventions effectively address the SDMs’ emotional needs during ICU stays. This project will evaluate the efficacy and mechanisms of REFRAME, a brief, self-directed, tablet-based intervention grounded in cognitive reappraisal theory. REFRAME is designed to help SDMs recognize, reinterpret, and regulate their emotional responses in real time as they navigate high-stakes decisions. The intervention includes interactive psychoeducation and emotional assessments, guided strategy selection, emotionally relevant ICU scenarios, and structured planning to apply reappraisal techniques to real-world decision-making. In a two-arm, parallel-group randomized controlled trial, 387 SDMs of critically ill patients will be enrolled and randomized to either the REFRAME intervention or an attention-matched informational support (IS) control condition. Participants will complete standardized outcome measures at baseline (T0), 24-48 hours post- intervention (T1), 24-48 hours post-T1 (T2), and 90 days post-baseline (T3). Aim 1 will evaluate the effects of REFRAME on depressive symptoms (primary outcome at T2) and PTSD symptoms and decision regret (secondary outcomes at T3). Aim 2 will examine differences between groups in state emotion regulation (cognitive reappraisal and expressive suppression) at T1. Aim 3 will test whether changes in state emotion regulation mediate the effect of the intervention condition on psychological outcomes. By targeting a core, modifiable mechanism—emotion regulation—this trial aims to enhance psychological resilience, decision-making quality, and overall family-centered outcomes. The study findings will guide the development of scalable, mechanism-focused interventions to alleviate mental health burdens and improve care experiences in critical care and other surrogate decision-making contexts. Project Number: 1R01AG100745-01 | Fiscal Year: 2026 | NIH Institute/Center: National Institute on Aging (NIA) | Principal Investigator: Grant Pignatiello | Institution: CASE WESTERN RESERVE UNIVERSITY, CLEVELAND, OH | Award Amount: $659,056 | Activity Code: R01 | Study Section: Special Emphasis Panel[ZRG1 CCHI-D (57)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11345828