Optimizing a Mobile Mindfulness Intervention for ICU Survivors

Not Applicable

Completed

• Conditions: Cardiorespiratory Failure
• Interventions: Behavioral: Mobile mindfulness-based training

• Registration Number: NCT04038567
• Lead Sponsor: Duke University

Brief 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.

Study Timeline

• Study First Submitted: 2019-07-24
• Study First Submitted QC: 2019-07-26
• Study First Posted: 2019-07-31
• Study Start: 2019-08-15
• Primary Completion: 2023-05-01
• Study Completion: 2023-07-19
• Results First Submitted: 2024-04-17
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-23
• Last Update Submitted: 2024-07-23
• Results First Posted: 2024-08-15
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 247

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard dose	Mobile mindfulness-based training	Standard dose of meditation time (once a day).
High dose	Mobile mindfulness-based training	High dose of meditation time (twice a day).
Therapist introduction to intervention	Mobile mindfulness-based training	Introduction to intervention via a call from the study therapist.
App introduction to intervention	Mobile mindfulness-based training	Introduction to intervention via the mobile app itself.
App response to symptoms	Mobile mindfulness-based training	Mobile app response to elevated psychological distress symptoms during intervention period.
Therapist response to symptoms	Mobile mindfulness-based training	Therapist call in response to elevated psychological distress symptoms during intervention period.

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9 Item Scale (PHQ-9)	1 month post-randomization	Absolute values, not change scores. Depression symptoms. Scores range from 0 (better) to 27 (worse)

Secondary Outcome Measures

Name	Time	Method
EuroQOL Scale	Between baseline and 1 month post-randomization	This is an absolute, not change, value. the EuroQOL is a measure of quality of life. Scores can range from 0 (worst) to 100 (best)
Intervention Adherence: Number of Views of Content	1 month post-randomization	Quantified by mean (SD) number of intervention content (audio, video, text) views
Distress Associated With Depression Symptom Frequency	At 1 month post-randomization	A visual analog scale appended to the PHQ-9 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PHQ-9. Scores range from 0 (best) to 100 (worst)
Generalized Anxiety Disorder 7-item Scale (GAD-7)	Between baseline 3 months post-randomization	Absolute values, not change scores. Anxiety symptoms. Scores range from 0 (better) to 21 (worse)
Intervention Adherence: Activity in App During Final Week of Intervention	1 month post-randomization	Quantified by number with activity (or not) in app during final week (4) of intervention
Client Satisfaction Questionnaire (CSQ)	1 month post-randomization	A measure of acceptability. Scores can range from 8 (worst) to 32 (best)
Systems Usability Scale (SUS)	1 month post-randomization	A measure of intervention usability. Each of 10 items is scored from 1 to 5. For each of the odd numbered questions, subtract 1 from the score.; For each of the even numbered questions, subtract their value from 5. Take these new values and add up the total score. Then multiply this by 2.5.Scores can range from 0 (worst) to 100 (best)
Change in EuroQOL Scale	Between baseline 3 months post-randomization	A measure of quality of life. Scores can range from 0 (worst) to 100 (best)
Mindful Attention Awareness Scale (MAAS)	Between baseline 3 months post-randomization	These are absolute values, not change scores. A measure of mindfulness qualities. Scores can range from 5 (worst) to 30 (best).
Patient Health Questionnaire-9 Item Scale (PHQ-9)	Between baseline 3 months post-randomization	Absolute values, not change scores. Depression symptoms. Scores range from 0 (better) to 27 (worse)
Post-Traumatic Stress Symptom Inventory (PTSS)	Between baseline and 1 month post-randomization	Absolute values, not change scores. Post-traumatic stress disorder symptoms. Scores can range from 10 (best) to 70 (worst).
Patient Health Questionnaire 10-item Scale (PHQ-10)	Between baseline 3 months post-randomization	This is an absolute value, not a change score. An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 10 (best) to 20 (worst).
Distress Associated With PTSD Symptom Frequency	At 3 months post-randomization	Absolute values, not change scores. A visual analog scale appended to the PTSS which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PTSS. Scores range from 0 (best) to 100 (worst)
Distress Associated With Anxiety Symptom Frequency	Between baseline 3 months post-randomization	A visual analog scale appended to the GAD-7 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the GAD-7. Scores range from 0 (best) to 100 (worst)

Trial Locations

Locations (3)

University of Washington; 🇺🇸 Seattle, Washington, United States

University of Colorado - Denver; 🇺🇸 Aurora, Colorado, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States