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

1. června 2026 aktualizováno: Duke University

Self-directed Mobile Mindfulness to Address ICU Survivors' Psychological Distress: the Lift RCT sIRB

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

450

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Spojené státy
    • California
      • Los Angeles, California, Spojené státy, 90048
        • Cedars-Sinai Medical Center
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Matthew Modes, MD
    • North Carolina
      • Durham, North Carolina, Spojené státy, 27710
        • Duke University Medical Center
    • South Carolina
      • Charleston, South Carolina, Spojené státy, 29403
        • Medical University of South Carolina

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Lift mobile mindfulness
Mobile app-based mindfulness program
Behaviorální: Lift mobile mindfulness
Mobile app-based mindfulness program for serious illness survivors
Aktivní komparátor: Enlighten Recovery education program
Mobile app-based critical illness education program
Behaviorální: Enlighten Recovery education program
Mobile app-based critical illness education program for serious illness survivors

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Patient Health Questionnaire 9-item depression scale (PHQ-9)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Generalized Anxiety Disorder 7-item scale (GAD-7)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Duke University

Spolupracovníci

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

Vyšetřovatelé

  • Vrchní vyšetřovatel: Christopher Cox, MD, MHA, MPH, Duke University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

28. února 2031

Dokončení studie (Odhadovaný)

31. května 2031

Termíny zápisu do studia

První předloženo

1. června 2026

První předloženo, které splnilo kritéria kontroly kvality

1. června 2026

První zveřejněno (Aktuální)

8. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

1. června 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • Pro00118118
  • 1UG3AT013109-01 (Grant/smlouva NIH USA)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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