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NCT Number: NCT07630844

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.

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Key information

Conditions

Critical Illness Behavior Disease Attributes Emotional Regulation Pathologic Processes Pathological Conditions, Signs and Symptoms Self-Control Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location contact

Grant Pignatiello, PhD

CONTACT

[email protected]

216-368-4480

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Grant Pignatiello, PhD

CONTACT

[email protected]

216-368-4480

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2031
Study completion
2031
First posted
Jun 5, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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