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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REFRAME | Experimental | Tablet-Based Emotion Regulation Tool |
|
| Informational Support | Other | Video-Based Psychoeducational Attention Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Patient Inclusion Criteria:
Legally Authorized Representative Inclusion Criteria (Primary Participant)
Patient Exclusion Criteria:
Legally Authorized Representative Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grant Pignatiello, PhD | Contact | 216-368-4480 | gap54@case.edu |
| Name | Affiliation | Role |
|---|---|---|
| Grant Pignatiello, PhD | Case Western Reserve University | Principal Investigator |
| S. Alan Hoffer, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000068356 | Self-Control |
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| 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. |
|
| 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. | 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. | Baseline and 90 days post-baseline |
| D012919 | Social Behavior |
| D001519 | Behavior |