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

Award Number: R01AG100745
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/01/2026
PERIOD OF PERFORMANCE END DATE: 05/31/2031

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $784,590 )
2026	2026	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Aging Research	001	1	8/14/2026	NEW	$125,534
2026	2026	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Aging Research	000	1	5/27/2026	NEW	$659,056
														Subtotal = $784,590

Grand Total All Awards = $784,590

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

Award Number: R01AG100745

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 06/01/2026

PERIOD OF PERFORMANCE END DATE: 05/31/2031

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