Self-directed Mobile Mindfulness to Address ICU Survivors' Psychological Distress

Official title

Self-directed Mobile Mindfulness to Address ICU Survivors' Psychological Distress: Lift RCT (Lift 3)

Overview

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.

Detailed description

Cardiorespiratory conditions such as the acute respiratory distress syndrome (ARDS), congestive heart failure, COVID pneumonia, and sepsis are among the most common causes of mortality and morbidity. They are also notable for high rates of persistent psychological distress symptoms including depression, anxiety, and PTSD that worsen quality of life and outcomes of the underlying conditions. Yet there are few effective strategies able to overcome barriers of limited access to mental health care.

To address this gap, the researchers developed Lift, a completely automated and self-directed mindfulness training intervention, from the ground up with patient input. First, Lift reduced depression symptoms and improved quality of life compared to an education program control in a multicenter pilot RCT (R34 AT008819) among those recently hospitalized with serious cardiorespiratory conditions. Next, a 247-person multicenter 2x2x2 factorial optimization trial (U01 AT00974) compared 8 intervention versions differing by program introduction (app vs. therapist), dose (standard vs. high), and approach to in-the-moment symptom management (app vs. therapist). This trial demonstrated that while all versions had a strong effect on depression, anxiety, and PTSD symptoms, the high dose, app-only version was optimized for effect, adherence, and retention.

Given these promising findings, a formal test of the optimized Lift mobile mindfulness intervention's efficacy is needed. Therefore, the investigators propose a 4-site multicenter RCT with 6-month follow up among 450 cardiorespiratory failure survivors with elevated post-discharge symptoms of psychological distress. The specific aims will: (1) Test Lift vs. an education program control delivered by similar platforms on symptoms of depression, anxiety, PTSD, and quality of life; (2a) Determine patient-level characteristics associated with a greater treatment response among a priori-defined subgroups using a heterogeneity of treatment effects analysis; (2b) Explore novel adherence metrics and outcomes; and (3) Ensure off-the-shelf intervention readiness with an exploratory mixed-methods hybrid type 1 implementation framework analysis that integrates quantitative trial implementation data with semi-structured trial participant interviews.

Innovative and unique elements include a fully automated mobile health delivery system that personalizes content in response to changes in symptom trajectories, the inclusion of Spanish language versions of intervention and control programs, and strong community engagement with formalized roles. This project addresses national research priorities and could advance the field with a personalizable yet population-scalable therapy that has the potential to broadly improve mental health access.

Interventions

• Behavioral Lift mobile mindfulness
  Mobile app-based mindfulness program for serious illness survivors
• Behavioral Enlighten Recovery education program
  Mobile app-based critical illness education program for serious illness survivors

Primary outcome measures

• Patient Health Questionnaire 9-item depression scale (PHQ-9) [Time frame: Baseline to 1 month]

Secondary outcome measures (11)

• Generalized Anxiety Disorder 7-item scale (GAD-7) [Time frame: Baseline to 3 months]
• Generalized Anxiety Disorder 7-item scale (GAD-7) [Time frame: Baseline to 6 months]
• The Post-Traumatic Stress Syndrome inventory (PTSS) [Time frame: Baseline to 1 month]
• The Post-Traumatic Stress Syndrome inventory (PTSS) [Time frame: Baseline to 3 months]
• The Post-Traumatic Stress Syndrome inventory (PTSS) [Time frame: Baseline to 6 months]
• The EuroQOL-5D (EQ-5D) [Time frame: Baseline to 1 month]
• The EuroQOL-5D (EQ-5D) [Time frame: Baseline to 3 months]
• The EuroQOL-5D (EQ-5D) [Time frame: Baseline to 6 months]
• The Patient Health Questionnaire 10-Item scale (PHQ-10) [Time frame: Baseline to 1 month]
• The Patient Health Questionnaire 10-Item scale (PHQ-10) [Time frame: Baseline to 3 months]
• The Patient Health Questionnaire 10-Item scale (PHQ-10) [Time frame: Baseline to 6 months]

Eligibility criteria

Inclusion criteria

Inclusion criteria present during hospitalization

• Adult (age ≥18)
• Managed in an ICU for ≥24 hours during the time inclusion criterion #3 is met
• 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
• Cognitive status intact

o No history of pre-existing significant cognitive impairment (e.g., dementia) as per medical chart

• 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

• 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):

• Severe psychological distress as assessed by endorsement of active suicidality (see Protection of Human Subjects document for study team management of this finding)
• Failure to randomize within 1 month after discharge from the hospital to home
• Failure to login to study app and access content within 2 weeks after randomization

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Supportive care

Study locations

United States · 3 centers

• Cedars-Sinai Medical Center — Los Angeles
• Duke University Medical Center — Durham
• Medical University of South Carolina — Charleston

Publications

• Cox CE, Gallis JA, Olsen MK, Porter LS, Gremore T, Greeson JM, Morris C, Moss M, Hough CL. Mobile Mindfulness Intervention for Psychological Distress Among Intensive Care Unit Survivors: A Randomized Clinical Trial. JAMA Intern Med. 2024 Jul 1;184(7):749-759. doi: 10.1001/jamainternmed.2024.0823. PMID 38805199
• Cox CE, Hough CL, Jones DM, Ungar A, Reagan W, Key MD, Gremore T, Olsen MK, Sanders L, Greeson JM, Porter LS. Effects of mindfulness training programmes delivered by a self-directed mobile app and by telephone compared with an education programme for survivors of critical illness: a pilot randomised clinical trial. Thorax. 2019 Jan;74(1):33-42. doi: 10.1136/thoraxjnl-2017-211264. Epub 2018 May 23. PMID 29793970

Identifiers

NCT: NCT07634419 · Pro00118118 · 1UG3AT013109-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗