Self-directed Mobile Mindfulness to Address ICU Survivors' Psychological Distress
Self-directed Mobile Mindfulness to Address ICU Survivors' Psychological Distress: Lift RCT (Lift 3)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests Lift, a mobile app that teaches mindfulness, or paying attention to the present moment. It is for adults who return home after intensive care for a serious heart or lung illness and have symptoms of depression. Researchers will compare Lift with an illness education program called Enlighten Recovery to see whether it improves mental health and quality of life over six months.
Serious acute heart and lung illnesses like heart failure, severe COVID, and sepsis often leave survivors struggling not only physically, but also with lasting depression, anxiety, and stress. These problems that are hard to treat because access to mental health care is often limited. To help address this, the researchers created Lift, a fully automated mindfulness program designed with patient input and delivered through a mobile app. The investigators now plan a large, multi-site study to test whether Lift improves mental health and quality of life over six months compared to a critical illness education program called Enlighten Recovery. Overall the goal is to make an easy-to-use, widely accessible program available to people across the U.S., including those who speak Spanish.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older.
- Have spent at least 24 hours in an intensive care unit (ICU) while meeting the study’s serious heart or lung illness rules.
- Have needed certain breathing support, oxygen, heart or blood pressure treatments, or urgent heart testing; or have signs of suddenly reduced blood flow to the heart. Specific treatment and time limits apply.
- Have no past major problems with memory or thinking, such as dementia.
- Have no severe or lasting mental illness, including treatment for one or a hospital stay for any mental illness in the six months before this hospital stay.
- Know enough English or Spanish to watch study videos and complete surveys.
- After returning home, score at least 5 on the PHQ-9, a survey about depression symptoms.
Who can't join
- Leave the hospital for somewhere other than home, such as a nursing home or a live-in rehabilitation center.
- Report active thoughts of suicide after returning home.
- Not be assigned by chance to a study group within one month after leaving the hospital for home.
- Not log in to the study app and open its content within two weeks after being assigned to a study group.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: Inclusion criteria present during hospitalization 1. Adult (age ≥18) 2. Managed in an ICU 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 o No history of pre-existing significant cognitive impairment (e.g., dementia) as per medical chart 5. Absence of severe and/or persistent mental illness o Treatment for severe and/or persistent 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 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 PHQ-9 score ≥5 Exclusion Criteria: Exclusion criteria present in the hospital: 1\. Discharged to a location other than a home setting (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility) Exclusion criteria present after hospital discharge (i.e., at T1 Data Collection conducted at the time of arrival home from the hospital): 1. Severe psychological distress as assessed by endorsement of active suicidality (see Protection of Human Subjects document for study team management of this finding) 2. Failure to randomize within 1 month after discharge from the hospital to home 3. Failure to login to study app and access content within 2 weeks after randomization
Study sites (3)
CA
- Cedars-Sinai Medical Center · Los Angeles, CA 90048Matthew Modes, MD · Study contact · Matthew.Modes@cshs.orgMatthew Modes, MD · Principal investigatorMore trials in Los Angeles
NC
- Duke University Medical Center · Durham, NC 27710More trials in Durham
SC
- Medical University of South Carolina · Charleston, SC 29403More trials in Charleston