About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Age ≥ 35 years
2. Lacks decision-making capacity
3. Not expected to be discharged from the ICU in 24 hours (including death)
1. Age ≥ 18 years
Disqualifiers
1. Age < 35 years
2. Possesses decision-making capacity
3. Anticipated discharge from ICU within next 24 hours.
1. Age < 18 years
Trial design
Parallel
Treatments tested in this trial
REFRAME
Behavioralconsists 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.
Informational Support
BehavioralThe informational support (IS) condition functions as an attention-matched psychoeducational control, featuring three sequential video-based modules delivered every 24-48 hours.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
Sponsors and contacts
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