NCT04038567

Optimizing a Mobile Mindfulness Intervention for ICU Survivors

Optimizing a Self-directed Mobile Mindfulness Intervention for Improving Cardiorespiratory Failure Survivors' Psychological Distress

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

As survival has improved for the 2 million people with cardiorespiratory failure managed annually in US intensive care units (ICUs), it has become apparent that these patients suffer from severe and persistent post-discharge symptoms of psychological distress including depression, anxiety, and post-traumatic stress disorder (PTSD). However, few targeted interventions exist that are relevant to patients' experiences and that accommodate their many physical, social, and financial barriers to personalized care. To fill this gap, an innovative app-based mobile mindfulness training program twas developed hat promotes automated care delivery and self-management of symptom-related distress. Subsequently, a pilot randomized clinical trial (RCT) called the LIFT study (R34 AT00819) compared mobile mindfulness to both a standard telephone mindfulness program and an ICU education control among survivors of cardiorespiratory failure. Key findings were that mobile mindfulness was feasibly delivered, acceptable, usable, and had a greater clinical impact on psychological distress than either comparator. This trial also highlighted opportunities to improve the intervention's impact related to its targeted population, content delivery, and system technology. To address these gaps, this 5-year project is conceptualized as the Optimization Phase of a multiphase optimization strategy (MOST) framework. It will optimize mobile mindfulness with four specific aims as described in the following sections. At the conclusion of this factorial randomized clinical trial study involving 240 cardiorespiratory failure survivors, a mobile mindfulness system fully optimized for usability, efficiency, scalability, and clinical impact will be delivered that will be off-the-shelf ready for a next-step definitive RCT-and can serve as a model for distance-based mind and body interventions.

Conditions

• Cardiorespiratory Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-08-15
• Primary completion: 2023-05-01
• Completion: 2023-07-19
• First posted: 2019-07-31
• Last updated: 2024-08-15
• Results posted: 2024-08-15

Locations

3 sites across 1 country: United States