Critical IllnessNCT07630844
REFRAME: an Emotion Regulation Intervention to Improve Psychological Outcomes in Surrogate Decision-Makers of the Critically Ill
A study testing REFRAME and Informational Support in people with Critical Illness, run by Case Western Reserve University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- REFRAME and Informational Support
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 387 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2027to 4 Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Grant Pignatiello, PhD, 216-368-4480, gap54@case.edu
About this study
Official title: 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.
- Conditions
- Critical Illness
- Being tested
- REFRAME, Informational Support
- Keywords
- Emotion Regulation, Psychological Distress, Surrogate Decision-Makers
- Medical subject headings
- Critical Illness, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REFRAMEBehavioural
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 SupportBehavioural
The informational support (IS) condition functions as an attention-matched psychoeducational control, featuring three sequential video-based modules delivered every 24-48 hours.
| Study group | Role | What they receive |
|---|---|---|
| REFRAME | Experimental | Tablet-Based Emotion Regulation Tool Receives: Behavioral: REFRAME |
| Informational Support | Other | Video-Based Psychoeducational Attention Control Receives: Behavioral: Informational Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Baseline and 90 days post-baseline
Change in Decision Regret as measured by the Decision Regret Scale
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.
Measured: Baseline and 90 days post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start4 Jan 2027 (estimated)
- Primary completion4 Apr 2031 (estimated)
- Study completion4 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 387 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grant Pignatiello, Case Western Reserve University
- Investigators
- Grant Pignatiello, PhD, Principal investigator, Case Western Reserve UniversityS. Alan Hoffer, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630844
- Sponsor's protocol ID
- STUDY20260222
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of REFRAME: an Emotion Regulation Intervention to Improve Psychological Outcomes in Surrogate Decision-Makers of the Critically Ill
- ClinicalTrials.gov ID
- NCT07630844
- Acronym / sponsor ID
- STUDY20260222
- Conditions
- Critical Illness
- Keywords
- Emotion Regulation, Psychological Distress, Surrogate Decision-Makers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 387 participants (estimated)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- 4 Jan 2027 (estimated)
- Primary completion
- 4 Apr 2031 (estimated)
- Study completion
- 4 Apr 2031 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REFRAME | Experimental | Behavioral: REFRAMETablet-Based Emotion Regulation Tool |
| Informational Support | Other | Behavioral: Informational SupportVideo-Based Psychoeducational Attention Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REFRAMEconsists 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. | Behavioural | REFRAME |
| Informational SupportThe informational support (IS) condition functions as an attention-matched psychoeducational control, featuring three sequential video-based modules delivered every 24-48 hours. | Behavioural | Informational Support |
Primary outcome
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.
3 secondary outcomes
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
Change in PTSD symptoms as measured by the PTSD Checklist for the DSM-5 (PCL-5)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grant Pignatiello, PhD principal investigator
Case Western Reserve University
S. Alan Hoffer, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REFRAME and Informational Support in people with Critical Illness, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grant Pignatiello, PhD (216-368-4480, gap54@case.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.