About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult (age ≥18)

Managed in an ICU for ≥24 hours during the time inclusion criterion #3 is met

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

450 Participants

are divided into 2 treatment groups

Group A: Lift mobile mindfulnessExperimental treatment 1 intervention

Group B: Enlighten Recovery education programActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Patient Health Questionnaire 9-item depression scale (PHQ-9)

The PHQ-9 is a primary trial outcome measure and the PHQ-9 score at 1 month is the primary trial outcome (Kroenke K, et al. J Gen Intern Med 606-13, 2001). The PHQ-9 is a well-validated metric with English and Spanish versions used in thousands of RCTs. Scores can range from 0 (no depression symptoms) to 27 (serious depression symptoms). The PHQ-9 MCID is 2-4 units.

Time frame

Baseline to 1 month

Secondary outcomes

1

Generalized Anxiety Disorder 7-item scale (GAD-7)

The GAD-7, like the related PHQ-9, has excellent psychodynamic properties including reliability, test-retest stability, accuracy, responsiveness, and validity as supported by confirmatory factor analysis (Spitzer RL, et al. Arch Intern Med. 166:1092-1097, 2006). GAD-7 scores can range from 0 \[no distress\] to 21 \[high distress\]); symptom severity is interpreted as mild (5-9), moderate (10-14), and severe (15-21). The GAD-7 MCID is 2-4 units.

Time frame

Baseline to 3 months

2

Generalized Anxiety Disorder 7-item scale (GAD-7)

The GAD-7, like the related PHQ-9, has excellent psychodynamic properties including reliability, test-retest stability, accuracy, responsiveness, and validity as supported by confirmatory factor analysis (Spitzer RL, et al. Arch Intern Med. 166:1092-1097, 2006). GAD-7 scores can range from 0 \[no distress\] to 21 \[high distress\]); symptom severity is interpreted as mild (5-9), moderate (10-14), and severe (15-21). The GAD-7 MCID is 2-4 units.

Time frame

Baseline to 6 months

3

The Post-Traumatic Stress Syndrome inventory (PTSS)

The PTSS rates 10 post-traumatic stress symptoms (range 10 \[no symptoms\] to 70 \[high burden of symptoms\]). A score \>20 represents clinically important PTSD symptoms, while a score \>=34 suggests likely PTSD.(Nickel M, et al. J Int Care Med. 19:285-290, 2004; Stoll C, et al. Int Care Med. 25:697-704, 1999) Compared to DSM-IV criteria, it is 98% specific and 77% sensitive for the diagnosis of PTSD among ICU survivors.(Stoll C, et al. Int Care Med. 25:697-704, 1999) The PTSS has excellent internal consistency, reliability, and responsiveness. (Schelling G, et al. Crit Care Med. 26:651-659, 1998; Twigg E, et al. Acta Anaesth Scand. 52:202-208, 2008) Furthermore, it is short and easily understood. Although formal psychometric testing has not clearly defined the PTSS's minimal clinically important difference, a 5-unit change represents a significant change in score in a single item and will therefore be used as a benchmark for this project.

Time frame

Baseline to 1 month

4

The Post-Traumatic Stress Syndrome inventory (PTSS)

The PTSS rates 10 post-traumatic stress symptoms (range 10 \[no symptoms\] to 70 \[high burden of symptoms\]). A score \>20 represents clinically important PTSD symptoms, while a score \>=34 suggests likely PTSD.(Nickel M, et al. J Int Care Med. 19:285-290, 2004; Stoll C, et al. Int Care Med. 25:697-704, 1999) Compared to DSM-IV criteria, it is 98% specific and 77% sensitive for the diagnosis of PTSD among ICU survivors.(Stoll C, et al. Int Care Med. 25:697-704, 1999) The PTSS has excellent internal consistency, reliability, and responsiveness. (Schelling G, et al. Crit Care Med. 26:651-659, 1998; Twigg E, et al. Acta Anaesth Scand. 52:202-208, 2008) Furthermore, it is short and easily understood. Although formal psychometric testing has not clearly defined the PTSS's minimal clinically important difference, a 5-unit change represents a significant change in score in a single item and will therefore be used as a benchmark for this project.

Time frame

Baseline to 3 months

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts