Critical Illness
Conditions
Keywords
Emotion Regulation, Psychological Distress, Surrogate Decision-Makers
Brief summary
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.
Interventions
BEHAVIORALREFRAME
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.
BEHAVIORALInformational Support
The informational support (IS) condition functions as an attention-matched psychoeducational control, featuring three sequential video-based modules delivered every 24-48 hours.
Sponsors
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient Inclusion Criteria: * 1\. Age ≥ 35 years * 2\. Lacks decision-making capacity * 3\. Not expected to be discharged from the ICU in 24 hours (including death) Legally Authorized Representative Inclusion Criteria (Primary Participant) * 1\. Age ≥ 18 years * 2\. Identified as LAR by ICU team * 3\. Able to speak and understand English * 4\. Able to visualize content on a tablet device Patient
Exclusion criteria
* 1\. Age \< 35 years * 2\. Possesses decision-making capacity * 3\. Anticipated discharge from ICU within next 24 hours. Legally Authorized Representative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in depressive symptoms as measured by PROMIS Emotional Distress-Depression Short Form | Baseline, 5-7 days post-baseline, and 90-days post-baseline. | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in cognitive reappraisal/expressive suppression as measured by the Emotion Regulation Questionnaire-State (ERQ-S) | Baseline, 4-5 days post-baseline, and 90 days post-baseline | 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) | Baseline and 90 days post-baseline | 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 | Baseline and 90 days post-baseline | 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. |
Countries
United States
Contacts
CONTACTGrant Pignatiello, PhD
PRINCIPAL_INVESTIGATORGrant Pignatiello, PhD
Case Western Reserve University
PRINCIPAL_INVESTIGATORS. Alan Hoffer, MD
University Hospitals Cleveland Medical Center
Outcome results
None listed