Evaluation of a Tablet-Based Emotion Regulation Intervention for Surrogate Decision-Makers of Patients With Critical Illness: Pilot Nonrandomized Trial.

backgroundPsychological distress among surrogate decision-makers (surrogates) for patients with critical illness is well documented. Existing interventions for supporting surrogates in their role often target surrogates' informational needs without directly addressing surrogates' acute emotional burden. Therefore, we developed the Reappraisal-Enhanced Foundation for Regulating Affect and Managing Emotions (REFRAME) intervention, a tablet-based app that empowers surrogates to manage their psychological distress with cognitive reappraisal.

objectiveWe sought to (1) determine the feasibility, acceptability, and appropriateness of implementing REFRAME and (2) examine its preliminary effects on surrogates' psychological distress.

methodsWe conducted a pilot nonrandomized trial at a tertiary medical center in northeast Ohio. We recruited adult surrogates for incapacitated intensive care unit (ICU) patients (≥48 hours). The first 20 participants received usual care (UC); the next 28 received UC and REFRAME, consisting of 3 sequential 10- to 15-minute modules administered every 24 to 48 hours (T1-T3) post enrollment (T0). We evaluated implementation outcomes both quantitatively and qualitatively by describing enrollment and completion rates, surrogates' scores on the Acceptability of Intervention Measure and the Intervention Appropriateness Measure, and thematically analyzing feedback from each interventional module. We measured psychological distress with the Patient-Reported Outcomes Measurement Information System Anxiety and Depression short forms at enrollment (T0) and approximately 1-week post enrollment (T3). We used linear mixed-effects models to assess changes in anxiety and depression severity between groups from T0 to T3, adjusting for the surrogate's gender, patient relationship, prior decision-making experience, and perceived stress.

resultsOur analytic sample included 48 surrogates (UC=20; REFRAME=28). Two-thirds (19/28, 67.9%) of those assigned to REFRAME completed all 3 modules, with over 70% finding it acceptable and appropriate. Qualitative feedback indicated that surrogates appreciated the intervention's normalization of their emotions and provision of practical reappraisal strategies. Both groups showed reductions in psychological distress severity, with greater reductions in depressive symptoms reported by surrogates in the REFRAME group (d=0.68).

conclusionsREFRAME was feasible to implement, well-received by users, and considered relevant in the ICU setting. We observed preliminary improvement in depressive symptoms, though the effects on anxiety are less certain. Our findings indicate that incorporating brief cognitive reappraisal tools into routine ICU practice may support surrogates' psychological well-being. Larger, more diverse trials with longer follow-up are necessary to confirm these initial findings and assess their impact on shared decision-making.