REFRAME for Emotional Stress in Critical Illness
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new tool called REFRAME, a tablet-based program designed to help individuals manage emotional stress while making medical decisions for loved ones in the ICU. The study aims to determine if REFRAME can reduce emotional suffering and improve decision-making quality. It compares this tool with video-based informational support. Suitable participants are those who regularly make medical decisions for ICU patients and can use a tablet to view content. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance support for ICU decision-makers.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that the REFRAME program is safe for managing emotional stress?
Research has shown that cognitive reframing, a technique similar to the REFRAME tool under study, is generally safe and positively impacts managing stress, anxiety, and depression. Studies indicate that it can help people handle these issues without major side effects. For example, one study found that cognitive reframing helps people manage stress and anxiety, suggesting it is safe for most participants.
Cognitive therapy for post-traumatic stress disorder (PTSD) is another method known for its safety and effectiveness in treating emotional distress. This background suggests that the REFRAME tool, which uses similar concepts, is likely safe for users. Although specific data on negative effects for REFRAME is unavailable, its foundation on well-tested strategies provides reassurance about its safety in helping people manage emotional stress.12345Why are researchers excited about this trial?
Unlike traditional therapies for emotional stress in critical illness, which often include medications and in-person counseling, the REFRAME treatment is unique due to its digital and self-guided approach. This experimental tool is a tablet-based emotion regulation system, allowing patients to engage with therapy at their own pace and convenience, potentially improving accessibility and adherence. Researchers are excited about this innovation because it offers a new way to manage stress without the need for constant clinical oversight, making it especially valuable for individuals undergoing critical care. Additionally, the video-based psychoeducational component provides informational support, helping patients understand and manage their stress through easy-to-access resources.
What evidence suggests that this trial's treatments could be effective for managing emotional stress in critical illness?
Research has shown that the REFRAME program, a tablet-based tool, can assist people in managing emotions during difficult medical decisions in the ICU. In this trial, some participants will use REFRAME, which provides short lessons on emotion management, to better cope with stress. This tool is based on the Process Model of Emotion Regulation, which focuses on altering thoughts about a situation. This approach has been associated with reduced stress and improved emotional outcomes in challenging situations. Overall, early evidence suggests that REFRAME may help reduce emotional stress and enhance decision-making for families in crisis.36789
Who Is on the Research Team?
Grant Pignatiello, PhD
Principal Investigator
Case Western Reserve University
S. Alan Hoffer, MD
Principal Investigator
University Hospitals Cleveland Medical Center
Are You a Good Fit for This Trial?
This trial is for adults who are making important medical decisions on behalf of a loved one in the intensive care unit (ICU) and may be experiencing emotional stress. There are no specific inclusion or exclusion criteria listed.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants engage with the REFRAME tablet-based emotion regulation tool or receive video-based psychoeducational attention control
Follow-up
Participants are monitored for changes in anxiety, depression, cognitive reappraisal, expressive suppression, PTSD symptoms, and decision regret
What Are the Treatments Tested in This Trial?
Interventions
- Informational Support
- REFRAME
Trial Overview
The study is testing REFRAME, a short tablet-based program to help family decision-makers manage their emotions during a loved one's critical illness, compared to standard informational support. Participants will be randomly assigned to either group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Tablet-Based Emotion Regulation Tool
Video-Based Psychoeducational Attention Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Case Western Reserve University
Lead Sponsor
Citations
Effects of psychological intervention on outcomes of critically ...
Intensive care diaries reduce new onset post traumatic stress disorder following critical illness: a randomised, controlled trial. Crit Care. (2010) 14:R168 ...
Evaluation of a Tablet-Based Emotion Regulation Intervention ...
The first 20 participants received usual care (UC); the next 28 received UC and REFRAME, consisting of 3 sequential 10- to 15-minute modules ...
3.
thisinstitute.cam.ac.uk
thisinstitute.cam.ac.uk/blog/improving-outcomes-for-family-members-of-critical-illness-survivors/Working together to improve outcomes for family members of ...
We're learning more about the long-term challenges that can affect people who survive critical illness, from the physical, social, emotional ...
Comprehensive Review of Chronic Stress Pathways and ...
This review synthesizes current research on the neurological, immune, hormonal, and genetic pathways through which stress influences disease progression.
5.
ovc.ojp.gov
ovc.ojp.gov/sites/g/files/xyckuh226/files/media/document/ci_lr_cisd_efficacy_in_question-508.pdfCritical Incident Stress Debriefing (CISD): Efficacy in ...
Psychological debriefing is a secondary strategy for prevention of PTSD, depression, and other post-traumatic psychological sequelae. It is designed to mitigate.
Cognitive therapy for post-traumatic stress disorder following ...
In this article, we describe how to use cognitive therapy for PTSD (CT-PTSD), a first line treatment for PTSD recommended by the National Institute for Health ...
7.
journals.lww.com
journals.lww.com/ccejournal/fulltext/2021/04000/system_of_psychological_support_based_on_positive.21.aspxSystem of Psychological Support Based on Positive...
Our aim was to train and implement a psychological support based on positive suggestion program for the critically ill using doulas.
Critical Incident Stress Guide
Critical Incident Stress Management is system of education, prevention and mitigation of the effects from exposure to highly stressful critical incidents.
Post-intensive care syndrome symptoms and health ...
We found a significant prevalence of anxiety (45.8%), depression (25%), and PTSD (11.1%) symptoms among FDMs over the course of the study.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.