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

7. juli 2026 oppdatert av: Duke University

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

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

450

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • California
      • Los Angeles, California, Forente stater, 90048
        • Cedars-Sinai Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Matthew Modes, MD
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Duke University Medical Center
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29403
        • Medical University of South Carolina

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Lift mobile mindfulness
Mobile app-based mindfulness program
Atferdsmessig: Lift mobile mindfulness
Mobile app-based mindfulness program for serious illness survivors
Aktiv komparator: Enlighten Recovery education program
Mobile app-based critical illness education program
Atferdsmessig: Enlighten Recovery education program
Mobile app-based critical illness education program for serious illness survivors

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient Health Questionnaire 9-item depression scale (PHQ-9)
Tidsramme: Baseline to 1 month
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.
Baseline to 1 month

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Generalized Anxiety Disorder 7-item scale (GAD-7)
Tidsramme: Baseline to 3 months
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.
Baseline to 3 months
Generalized Anxiety Disorder 7-item scale (GAD-7)
Tidsramme: Baseline to 6 months
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.
Baseline to 6 months
The Post-Traumatic Stress Syndrome inventory (PTSS)
Tidsramme: Baseline to 1 month
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.
Baseline to 1 month
The Post-Traumatic Stress Syndrome inventory (PTSS)
Tidsramme: Baseline to 3 months
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.
Baseline to 3 months
The Post-Traumatic Stress Syndrome inventory (PTSS)
Tidsramme: Baseline to 6 months
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.
Baseline to 6 months
The EuroQOL-5D (EQ-5D)
Tidsramme: Baseline to 1 month
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.
Baseline to 1 month
The EuroQOL-5D (EQ-5D)
Tidsramme: Baseline to 3 months
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.
Baseline to 3 months
The EuroQOL-5D (EQ-5D)
Tidsramme: Baseline to 6 months
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.
Baseline to 6 months
The Patient Health Questionnaire 10-Item scale (PHQ-10)
Tidsramme: Baseline to 1 month
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.
Baseline to 1 month
The Patient Health Questionnaire 10-Item scale (PHQ-10)
Tidsramme: Baseline to 3 months
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.
Baseline to 3 months
The Patient Health Questionnaire 10-Item scale (PHQ-10)
Tidsramme: Baseline to 6 months
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.
Baseline to 6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Duke University

Samarbeidspartnere

National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)

Etterforskere

  • Hovedetterforsker: Christopher Cox, MD, MHA, MPH, Duke University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. januar 2027

Primær fullføring (Antatt)

28. februar 2031

Studiet fullført (Antatt)

31. mai 2031

Datoer for studieregistrering

Først innsendt

1. juni 2026

Først innsendt som oppfylte QC-kriteriene

1. juni 2026

Først lagt ut (Faktiske)

8. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. juli 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Pro00118118
  • 1UG3AT013109-01 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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