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

June 23, 2026 updated by: Grant Pignatiello, Case Western Reserve University

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

387

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Grant Pignatiello, PhD
  • Phone Number: 216-368-4480
  • Email: gap54@case.edu

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
        • Contact:
          • Grant Pignatiello, PhD
          • Phone Number: 216-368-4480
          • Email: gap54@case.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: REFRAME
Tablet-Based Emotion Regulation Tool
Behavioral: REFRAME
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.
Other: Informational Support
Video-Based Psychoeducational Attention Control
Behavioral: Informational Support
The informational support (IS) condition functions as an attention-matched psychoeducational control, featuring three sequential video-based modules delivered every 24-48 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depressive symptoms as measured by PROMIS Emotional Distress-Depression Short Form
Time Frame: 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.
Baseline, 5-7 days post-baseline, and 90-days post-baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cognitive reappraisal/expressive suppression as measured by the Emotion Regulation Questionnaire-State (ERQ-S)
Time Frame: 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.
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)
Time Frame: 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.
Baseline and 90 days post-baseline
Change in Decision Regret as measured by the Decision Regret Scale
Time Frame: 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.
Baseline and 90 days post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Western Reserve University

Investigators

  • Principal Investigator: Grant Pignatiello, PhD, Case Western Reserve University
  • Principal Investigator: S. Alan Hoffer, MD, University Hospitals Cleveland Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 4, 2027

Primary Completion (Estimated)

April 4, 2031

Study Completion (Estimated)

April 4, 2031

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20260222

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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