A Randomized Trial of REFRAME: an Emotion Regulation Intervention to Improve Psychological Outcomes in Surrogate Decision-Makers for Survivors of Invasive Mechanical Ventilation - Project Summary/Abstract Every year, over a million adults in the U.S. need invasive mechanical ventilation (IMV) in intensive care units (ICUs), often relying on a surrogate decision-maker (SDM) for treatment decisions for them. Although many patients survive and move to a hospital ward, this transition is stressful for SDMs, who face new caregiving roles and ongoing uncertainty. Many experience anxiety, depression, and decisional fatigue, which can hinder patient recovery and increase their risk for Post-Intensive Care Syndrome–Family (PICS-F), a cluster of psychological issues including PTSD and decision regret that may persist for months or years. Despite evidence that the ICU- to-ward shift is a vulnerable period with lasting effects on both SDMs and patients, few interventions target the emotional mechanisms behind these outcomes. This project will evaluate the efficacy and mechanisms of REFRAME, a brief, self-directed, tablet-based intervention grounded in emotion regulation theory. REFRAME trains SDMs to reappraise their emotional responses as they navigate the post-ICU period. The program includes interactive psychoeducation and emotional assessments, guided cognitive reappraisal strategies, and structured planning to apply cognitive reappraisal techniques to real-world decision-making. In this two-arm, parallel-group, randomized controlled trial, 376 SDMs of adults who require ≥ 72 hours of invasive mechanical ventilation and survive to ICU discharge will be randomized (1:1) to REFRAME or an attention-matched Informational Support (IS) control condition. Each condition consists of two 20-minute sessions delivered during the ICU-to-ward transfer. Proximal outcomes (cognitive appraisal, anxiety, depressive symptoms, decision fatigue) will be assessed at baseline (T0), 2–3 days (T1), 3–5 days (T2), and 4–7 days (T3) post-baseline. Distal outcomes (Decision regret and PTSD symptoms) will be assessed at 30 days post-baseline (T4). Aim 1 will examine whether SDMs randomized to REFRAME report more cognitive reappraisal use and lower symptoms of anxiety, depression, and decisional fatigue than SDMs randomized to IS. Aim 2 will examine whether SDMs randomized to REFRAME report more lower decision regret and PTSD symptoms than SDMs randomized to IS. Aim 3 will test whether REFRAME strengthens cognitive reappraisal’s associations with lower levels of anxiety, depression, and decision fatigue. By targeting emotion regulation, a core, modifiable process underlying stress adaptation, this trial will determine whether a scalable, mechanism-driven intervention can improve psychological well-being and decision-making in SDMs. Findings will inform the development of the next generation of on-demand, family-centered interventions to reduce risk factors for PICS-F and enhance recovery experiences following critical illness.
