An interventional study of Lift mobile mindfulness and Enlighten Recovery education program in Critical Illness, Heart Failure and Sepsis, sponsored by Duke University. Not yet recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Duke University · Not applicable, Interventional, and Supportive care
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.
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.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's planned enrollment of 450 is above the median of 90 across 979 interventional studies indexed under Critical Illness.
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Inclusion Criteria:
Inclusion criteria present during hospitalization
Serious acute cardiorespiratory condition, defined as ≥1 of the following:
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
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):
Mobile app-based mindfulness program
Behavioral: Lift mobile mindfulness
Mobile app-based critical illness education program
Behavioral: Enlighten Recovery education program
Mobile app-based mindfulness program for serious illness survivors
Mobile app-based critical illness education program for serious illness survivors
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
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
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
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
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
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 6 months
The EuroQOL-5D (EQ-5D)
The EQ-5D is an easily understood, validated 5-item (plus a 100-point visual analog scale) quality of life measure that has been used successfully in \>100 ICU survivor studies.(EuroQOL group. Health Policy. 16:199-208, 1990; Unroe M, et al. Ann Int Med. 153:167-175, 2010) It is considered a Core Measure for ICU outcomes research.
Time frame: Baseline to 1 month
The EuroQOL-5D (EQ-5D)
The EQ-5D is an easily understood, validated 5-item (plus a 100-point visual analog scale) quality of life measure that has been used successfully in \>100 ICU survivor studies.(EuroQOL group. Health Policy. 16:199-208, 1990; Unroe M, et al. Ann Int Med. 153:167-175, 2010) It is considered a Core Measure for ICU outcomes research.
Time frame: Baseline to 3 months
The EuroQOL-5D (EQ-5D)
The EQ-5D is an easily understood, validated 5-item (plus a 100-point visual analog scale) quality of life measure that has been used successfully in \>100 ICU survivor studies.(EuroQOL group. Health Policy. 16:199-208, 1990; Unroe M, et al. Ann Int Med. 153:167-175, 2010) It is considered a Core Measure for ICU outcomes research.
Time frame: Baseline to 6 months
The Patient Health Questionnaire 10-Item scale (PHQ-10)
The investigators will use the PHQ-10, which is an adaptation of the PHQ-15 (Kroenke K, et a. Psychosom Med. 64:258-66, 2002), a scale they have used successfully in past work, to assess physical symptoms across 10 domains. The PHQ-15 is reliable, responsive, and easily understood. The study team's PHQ-10 adaptation collapsed several pain items into a single item based on patient feedback. The scale is from 0 to 30.
Time frame: Baseline to 1 month
The Patient Health Questionnaire 10-Item scale (PHQ-10)
The investigators will use the PHQ-10, which is an adaptation of the PHQ-15 (Kroenke K, et a. Psychosom Med. 64:258-66, 2002), a scale they have used successfully in past work, to assess physical symptoms across 10 domains. The PHQ-15 is reliable, responsive, and easily understood. The study team's PHQ-10 adaptation collapsed several pain items into a single item based on patient feedback. The scale is from 0 to 30.
Time frame: Baseline to 3 months
The Patient Health Questionnaire 10-Item scale (PHQ-10)
The investigators will use the PHQ-10, which is an adaptation of the PHQ-15 (Kroenke K, et a. Psychosom Med. 64:258-66, 2002), a scale they have used successfully in past work, to assess physical symptoms across 10 domains. The PHQ-15 is reliable, responsive, and easily understood. The study team's PHQ-10 adaptation collapsed several pain items into a single item based on patient feedback. The scale is from 0 to 30, with higher scores meaning more functional issues.
Time frame: Baseline to 6 months
Plan to share: No
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Duke University