New app aims to ease mental health struggles after ICU stays
NCT ID NCT06538246
First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times
Summary
This study tests a mobile app called Blueprint that teaches coping skills to people who survived a serious illness in the ICU. Many survivors face anxiety, depression, and PTSD, but mental health care is hard to access. The app aims to help them manage these symptoms on their own. Researchers will enroll 400 adults from four hospitals and follow them for 6 months to see if the app improves their mental health compared to a standard education app.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria Inclusion criteria present in the hospital 1. Adult (age ≥18) 2. Managed in an ICU or stepdown unit for ≥24 hours during the time inclusion criterion #3 is met 3. Serious acute cardiorespiratory condition, defined as ≥1 of the following: * mechanical ventilation via endotracheal tube for ≥4 hours * non-invasive ventilation (CPAP, BiPAP) for ≥4 hours in a 24-hour period provided for acute respiratory failure * new use of supplemental oxygen ≥6 liters per minute (or increase in baseline continuous oxygen) * use of vasopressors for shock of any etiology * use of inotropes for shock of any etiology * use of pulmonary vasodilators * use of aortic balloon pump or cardiac assist device for cardiogenic shock * use of diuretic intravenous drip * evidence of acute coronary ischemia (i.e., elevated troponin level, supporting EKG changes, unstable angina symptoms documented) * urgent cardiac catheterization 4. Cognitive status intact • No history of pre-existing significant cognitive impairment (e.g., dementia) as per medical chart 5. Absence of severe mental illness * Treatment for severe mental illness (e.g., psychosis, bipolar affective disorder, schizoaffective disorder, schizoid personality disorder, schizophrenia \[as per medical record\], hospitalization for any psychiatric disorder) within the 6 months preceding the current hospital admission * Evidence of poorly managed severe mental illness * No endorsement of suicidality at time of admission or informed consent 6. Functional fluency in English or Spanish (i.e., sufficient knowledge of English or Spanish to complete study tasks like watch videos, complete surveys) Inclusion criteria present after hospital discharge (i.e., at the time of arrival home after discharge from the hospital) 1\. Elevated baseline psychological distress symptoms, defined as a Hospital Anxiety and Distress Scale (HADS) total score ≥8 Exclusion Criteria Exclusion criteria present in the hospital 1. Active alcohol or drug abuse (e.g., admission for alcohol withdrawal, drug-related complication, positive toxicology screening at admission, endorsement of active addiction) 2. Anticipated complex medical needs after discharge that would be disruptive to intervention and follow up; for example: * Anticipated surgical procedures * Anticipated complex medical regiment (e.g., new chemotherapy, new dialysis, need for repeat surgery, pregnant and near term) * Plan for comfort care 3. Other complex needs anticipated that could interfere with the ability to complete study procedures. Examples include: * Anticipated disruptive travel * Inability to use mobile app * Anticipated unstable living situation 4. Anticipated or actual discharge to a location other than independent in a home setting (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility, home hospice) 5. Persistently impaired cognition as a result of illness (Impairment defined as ≥3 errors on the Callahan cognitive status screen and/or the lack of decisional capacity (i.e., patient could be consented by medical team for a procedure if necessary) 6. Currently imprisoned or incarcerated or in home detention 7. Lack a reliable smartphone with cellular data plan or access to the internet 8. Currently enrolled in another study involving an intervention whose objectives conflict with the objectives of this study 9. Previously enrolled in the trial Exclusion criteria present after hospital discharge (i.e., at T1 Data Collection conducted at the time of arrival home from the hospital) 1. Failure to randomize within 14 days from planned start date (planned start date is within 3 days post-discharge from the hospital to home to accommodate weekends) 2. Readmission to hospital before randomization completed
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Duke University Medical Center
RECRUITINGDurham, North Carolina, 27710, United States
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