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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Western Reserve University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • REFRAME

    Behavioral

    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.

  • Informational Support

    Behavioral

    The informational support (IS) condition functions as an attention-matched psychoeducational control, featuring three sequential video-based modules delivered every 24-48 hours.

Treatment groups

387 Participants
are divided into 2 treatment groups
Group A: REFRAMEExperimental treatment 1 intervention
Group B: Informational SupportOther 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

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