An interventional study of REFRAME and Informational Support in Critical Illness, sponsored by Case Western Reserve University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Case Western Reserve University · Not applicable, Interventional, and Supportive care
Every year in the United States, millions of adults make crucial medical decisions for loved ones in the intensive care unit while facing extreme emotional stress. This project will assess REFRAME, a brief tablet-based program designed to help decision-makers manage their emotions in these situations. Results from this study may lead to the creation of a widely accessible tool that alleviates emotional suffering and enhances the quality of medical decision-making for families in crisis.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's planned enrollment of 387 is above the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Case Western Reserve University is the lead sponsor of 158 studies on the registry; 29 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patient Inclusion Criteria:
Legally Authorized Representative Inclusion Criteria (Primary Participant)
Patient Exclusion Criteria:
Legally Authorized Representative Exclusion Criteria:
Tablet-Based Emotion Regulation Tool
Behavioral: REFRAME
Video-Based Psychoeducational Attention Control
Behavioral: Informational Support
consists of three self-guided, tablet-based modules that align with the process model of emotion regulation. Each module lasts approximately 10-20 minutes and is delivered sequentially over three sessions, spaced 24-48 hours apart after enrollment.
The informational support (IS) condition functions as an attention-matched psychoeducational control, featuring three sequential video-based modules delivered every 24-48 hours.
Change in depressive symptoms as measured by PROMIS Emotional Distress-Depression Short Form
PROMIS Depression is an eight-item scale with items scored on a five-point Likert scale ranging from 1 (Never) to 5 (Always). Items are summed with higher scores indicating greater depressive symptoms.
Time frame: Baseline, 5-7 days post-baseline, and 90-days post-baseline.
Change in cognitive reappraisal/expressive suppression as measured by the Emotion Regulation Questionnaire-State (ERQ-S)
The ERQ-S is an eight-item scale with two subscales measuring use of cognitive reappraisal and expressive suppression. Items are scored on a 7-point Likert Scale ranging from 1 (Strongly Disagree) to 7 (Strongly Agree). Subscale scores are computed by calculating the mean of subscale items, with higher scores indicating greater use of the specified emotion regulation strategy.
Time frame: Baseline, 4-5 days post-baseline, and 90 days post-baseline
Change in PTSD symptoms as measured by the PTSD Checklist for the DSM-5 (PCL-5)
The PCL-5 is a 20-item questionnaire with items scored on a five-point Likert scale ranging from 0 (not at all) to 4 (extremely). Items are summed with higher scores indicating greater PTSD symptoms.
Time frame: Baseline and 90 days post-baseline
Change in Decision Regret as measured by the Decision Regret Scale
The Decision Regret Scale is a five-item scale with items scored on a five-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). Raw scores are transformed into a 0-100 scale, with higher scores indicating greater decision regret.
Time frame: Baseline and 90 days post-baseline
Plan to share: No
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Case Western Reserve University