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

7 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

450

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos, 90048
        • Cedars-Sinai Medical Center
        • Contacto:
        • Investigador principal:
          • Matthew Modes, MD
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27710
        • Duke University Medical Center
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29403
        • Medical University of South Carolina

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Lift mobile mindfulness
Mobile app-based mindfulness program
Conductual: Lift mobile mindfulness
Mobile app-based mindfulness program for serious illness survivors
Comparador activo: Enlighten Recovery education program
Mobile app-based critical illness education program
Conductual: Enlighten Recovery education program
Mobile app-based critical illness education program for serious illness survivors

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient Health Questionnaire 9-item depression scale (PHQ-9)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Generalized Anxiety Disorder 7-item scale (GAD-7)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Duke University

Colaboradores

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

Investigadores

  • Investigador principal: Christopher Cox, MD, MHA, MPH, Duke University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de enero de 2027

Finalización primaria (Estimado)

28 de febrero de 2031

Finalización del estudio (Estimado)

31 de mayo de 2031

Fechas de registro del estudio

Enviado por primera vez

1 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de junio de 2026

Publicado por primera vez (Actual)

8 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

7 de julio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Pro00118118
  • 1UG3AT013109-01 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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