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New app aims to ease mental health struggles after ICU stays

NCT ID NCT06538246

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

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Other studies related to the condition(s) this trial covers.