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

N/ANot Yet RecruitingNCT07630844

Case Western Reserve University387 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

387

Conditions

Critical Illness

Interventions

REFRAMEBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * 1\. Age \< 18 years * 2\. Not recognized as LAR by ICU team * 3\. Unable to speak and understand English * 4\. Unable to visualize content on a tablet device

Outcomes

Primary Outcomes

Change in anxiety symptoms as measured by the PROMIS Emotional Distress-Anxiety Short Form

PROMIS Anxiety 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 anxiety symptoms.

Time frame: Baseline, 5-7 days post-baseline, and 90-days post-baseline.

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.

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.

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.