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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Western Reserve University
Study ID
NCT07630844
Status
Not Yet Recruiting

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Conditions

  • Critical Illness

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jan 4, 2027
Status verified
Jun 2026
Primary completion
Apr 4, 2031
Completion
Apr 4, 2031

Study Design

Enrollment
387 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: REFRAME
    Tablet-Based Emotion Regulation Tool
  • Other: Informational Support
    Video-Based Psychoeducational Attention Control

Primary Outcome Measure

Change in anxiety symptoms as measured by the PROMIS Emotional Distress-Anxiety Short Form [ Time Frame: Baseline, 5-7 days post-baseline, and 90-days post-baseline. ]

Central Contacts

Locations (1)

FacilityCityStateZIP
University Hospitals Cleveland Medical CenterClevelandOhio44106

Find similar trials in Cleveland, OH

By research site
University Hospitals Cleveland Medical Center· Cleveland, OH

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