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

NCT07630844 | Not Yet Recruiting DMC

• 1 other identifier: STUDY20260222
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

Emotion Regulation; Psychological Distress; Surrogate Decision-Makers

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 5-7 days post-baseline, and 90-days post-baseline.

Secondary Outcomes (3)

• 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

• Change in PTSD symptoms as measured by the PTSD Checklist for the DSM-5 (PCL-5)

  Baseline and 90 days post-baseline

• Change in Decision Regret as measured by the Decision Regret Scale

  Baseline and 90 days post-baseline

Study Arms (2)

REFRAME

EXPERIMENTAL

Tablet-Based Emotion Regulation Tool

Behavioral: REFRAME

Informational Support

OTHER

Video-Based Psychoeducational Attention Control

Behavioral: Informational Support

Interventions

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.

REFRAME

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.

Informational Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥ 35 years
• \. Lacks decision-making capacity
• \. Not expected to be discharged from the ICU in 24 hours (including death)
• \. Age ≥ 18 years
• \. Identified as LAR by ICU team
• \. Able to speak and understand English
• \. Able to visualize content on a tablet device

You may not qualify if:

• \. Age \< 35 years
• \. Possesses decision-making capacity
• \. Anticipated discharge from ICU within next 24 hours.
• \. Age \< 18 years
• \. Not recognized as LAR by ICU team
• \. Unable to speak and understand English
• \. Unable to visualize content on a tablet device

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Critical Illness; Emotional Regulation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Self-Control; Social Behavior; Behavior

Study Officials

• Grant Pignatiello, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

• S. Alan Hoffer, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grant Pignatiello, PhD

CONTACT

216-368-4480; gap54@case.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): January 4, 2027
• Primary Completion (Estimated): April 4, 2031
• Study Completion (Estimated): April 4, 2031
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)