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Optimizing a Mobile Mindfulness Intervention for ICU Survivors

NCT04038567 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2024-08-15

Study results available
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Summary

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.

Conditions

  • Cardiorespiratory Failure

Interventions

BEHAVIORAL

Mobile mindfulness-based training

The intervention core is a mobile app-based mindfulness training program designed to be used over a 1-month period. All 6 factorial groups will use the app, though the delivery of the app and response to psychological distress symptoms over time will differ by group.

Sponsors & Collaborators

  • University of Washington

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Christopher E Cox, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-15
Primary Completion
2023-05-01
Completion
2023-07-19

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04038567 on ClinicalTrials.gov