~38 spots leftby Apr 2026

Optimizing a Mobile Mindfulness Intervention for ICU Survivors

(LIFT2 Trial)

Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byChristopher E Cox, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Duke University
No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a factorial experimental trial involving adult survivors of cardiorespiratory failure treated in intensive care units (ICUs) that is conceptualized as the Optimization Phase of a multiphase optimization strategy (MOST) framework. This will allow optimization of a mobile mindfulness intervention by comparing eight different iterations across domains including impact on symptoms, feasibility, acceptability, usability, scalability, and cost.

Eligibility Criteria

Inclusion Criteria

No history of pre-existing significant cognitive impairment (e.g., dementia) as per medical chart
Absence of current significant cognitive impairment (impairment defined as ≥3 errors on the Callahan cognitive status screen)
Acute cardiorespiratory failure: Acute respiratory failure, defined as ≥1 of the following: mechanical ventilation via endotracheal tube for ≥12 hours, non-invasive ventilation (CPAP, BiPAP) for ≥4 hours in a 24-hour period provided for acute respiratory failure in an ICU (not for obstructive sleep apnea or other stable use), high flow nasal cannula or face mask oxygen for ≥4 hours in a 24-hour period and / or Acute cardiac / circulatory failure, defined as ≥1 of the following: use of vasopressors for shock of any etiology for ≥1 hour, use of inotropes for shock of any etiology for ≥1 hour, use of pulmonary vascular vasoactive medications, use of aortic balloon pump for cardiogenic shock for ≥1 hour, Managed in an adult medical cardiac, trauma, surgical, or neurological ICU, stepdown unit, or monitored ward unit for ≥24 hours during the time inclusion criterion #2 is met.
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Exclusion Criteria

Hospitalized within the preceding 3 months with life-threatening illness or injury.
Patients may be enrolled into the study if they had a hospitalization within the preceding 3 months that is determined to be non-serious. Non-serious admissions are defined as those admissions that are non-life threatening and/or potentially impacting patient's well-being long-term or likely to precipitate additional future admissions. Examples of non-life-threatening hospitalizations could be, but may not be limited to, admission for a bronchoscopy, admission for deep vein thrombosis, or admission to ED resulting in overnight stay for cardiac work-up.
Complex medical care expected soon after discharge (e.g., planned surgeries, transplantation evaluation, extensive travel needs for hemodialysis, disruptive chemotherapy/radiation regimen)
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Treatment Details

Interventions

  • Mobile mindfulness-based training (Behavioral Intervention)
Participant Groups
6Treatment groups
Experimental Treatment
Group I: Therapist response to symptomsExperimental Treatment1 Intervention
Therapist call in response to elevated psychological distress symptoms during intervention period.
Group II: Therapist introduction to interventionExperimental Treatment1 Intervention
Introduction to intervention via a call from the study therapist.
Group III: Standard doseExperimental Treatment1 Intervention
Standard dose of meditation time (once a day).
Group IV: High doseExperimental Treatment1 Intervention
High dose of meditation time (twice a day).
Group V: App response to symptomsExperimental Treatment1 Intervention
Mobile app response to elevated psychological distress symptoms during intervention period.
Group VI: App introduction to interventionExperimental Treatment1 Intervention
Introduction to intervention via the mobile app itself.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
University of Colorado - DenverAurora, CO
Duke University Medical CenterDurham, NC
University of WashingtonSeattle, WA
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Who Is Running the Clinical Trial?

Duke UniversityLead Sponsor
University of WashingtonCollaborator
University of Colorado, DenverCollaborator
National Center for Complementary and Integrative Health (NCCIH)Collaborator

References