A Tablet-Based Emotion Regulation Program for Surrogate Decision-Makers of ICU Patients on Ventilation
Official title: A Randomized Trial of REFRAME: an Emotion Regulation Intervention to Improve Psychological Outcomes in Surrogate Decision-Makers for Survivors of Invasive Mechanical Ventilation
Funded at Case Western Reserve University · NIH-11431767 · Data updated 2026-11-12
A randomized trial tests a brief tablet program to help people who decide for ICU patients on ventilation feel less anxious and make better decisions.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Case Western Reserve University NIH-funded |
| Lab location | 1 site (Cleveland, United States) |
| Project start | September 11, 2026 |
| Project end | June 30, 2031 |
| Funding year | 2026 |
| Award (this year) | $782,106 |
| NIH project number | 1R01NR022609-01 |
| Project ID | NIH-11431767 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults who are SDMs for a loved one who required invasive mechanical ventilation for at least 72 hours and survived to ICU discharge.
✕Less likely to help
SDMs who do not engage with the tablet program or whose loved ones do not survive may see limited or no benefit.
What this research studies
If a loved one needs prolonged life support in the ICU, their surrogate may feel overwhelmed and emotionally strained. This study gives SDMs a 2-arm, brief, self-directed tablet intervention focused on reappraisal and planning to support decision-making after ICU discharge. About 376 surrogate decision-makers of adults who required at least 72 hours of invasive ventilation will participate, with outcomes measured over several months to see if distress and decision-making improve. The approach blends psychoeducation, emotional tracking, guided reappraisal, and real-world planning to support families and patients.
Why it matters
Potential benefit: If successful, SDMs may experience less anxiety and depression and make more confident decisions, potentially improving patient recovery and reducing family distress.
How similar studies have gone: Previous studies suggest emotion regulation approaches can reduce caregiver distress, but this trial tests a scalable, tablet-based program in a critical care context.
Where this research is happening
-
Case Western Reserve University
Cleveland, United States Active
Researchers
- Principal investigator: Pignatiello, Grant — Case Western Reserve University
- Study coordinator: Pignatiello, Grant
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.