Optimizing a Mobile Mindfulness Intervention for ICU Survivors

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiorespiratory Failure

Intervention / Treatment
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* Behavioral: Mobile mindfulness-based training


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA Adult (age ≥18) 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. Cognitive status intact 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) Decisional capacity present Absence of severe and/or persistent mental illness 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 No endorsement of suicidality at time of admission or informed consent No active substance abuse within the 3 months preceding the current admission serious enough to limit completion of study procedures in the opinion of the site investigator. English fluency. EXCLUSION CRITERIA (in hospital): 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. Admitted from a location other than home (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility) Anticipated or actual discharge to a location other than independent in a home setting (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility, home hospice) Complex medical care expected soon after discharge (e.g., planned surgeries, transplantation evaluation, extensive travel needs for hemodialysis, disruptive chemotherapy/radiation regimen) Unable to complete study procedures as determined by staff Lack of reliable smartphone with cellular data plan or wifi access EXCLUSION CRITERIA (at T1, post-discharge): Low baseline psychological distress symptoms, defined as the absence of the following at T1: PHQ-9 score <5 Failure to randomize within 2 month (60 days) post-discharge.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Factorial experimental trial as part of a multi-phase optimization strategy (MOST) design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose / therapist attention / introductory call<br>Will receive high dose intervention content, therapist attention to elevated symptoms, and an introductory call from a therapist. | Behavioral: Mobile mindfulness-based training<br>* The intervention core is a mobile app-based mindfulness training program designed to be used over a 1-month period. All 8 factorial groups will use the app, though the delivery of the app and response to psychological distress symptoms over time will differ by group.<br>|
| Experimental: High dose / therapist attention / no introductory call<br>Will receive high dose intervention content, therapist attention to elevated symptoms, and no introductory call from a therapist. | Behavioral: Mobile mindfulness-based training<br>* The intervention core is a mobile app-based mindfulness training program designed to be used over a 1-month period. All 8 factorial groups will use the app, though the delivery of the app and response to psychological distress symptoms over time will differ by group.<br>|
| Experimental: High dose / app attention / introductory call<br>Will receive high dose intervention content, app-based attention to elevated symptoms, and an introductory call from a therapist. | Behavioral: Mobile mindfulness-based training<br>* The intervention core is a mobile app-based mindfulness training program designed to be used over a 1-month period. All 8 factorial groups will use the app, though the delivery of the app and response to psychological distress symptoms over time will differ by group.<br>|
| Experimental: High dose / app attention / no introductory call<br>Will receive high dose intervention content, app-based attention to elevated symptoms, and no introductory call from a therapist. | Behavioral: Mobile mindfulness-based training<br>* The intervention core is a mobile app-based mindfulness training program designed to be used over a 1-month period. All 8 factorial groups will use the app, though the delivery of the app and response to psychological distress symptoms over time will differ by group.<br>|
| Experimental: Standard dose / therapist attention / introductory call<br>Will receive standard dose intervention content, therapist-based attention to elevated symptoms, and an introductory call from a therapist. | Behavioral: Mobile mindfulness-based training<br>* The intervention core is a mobile app-based mindfulness training program designed to be used over a 1-month period. All 8 factorial groups will use the app, though the delivery of the app and response to psychological distress symptoms over time will differ by group.<br>|
| Experimental: Standard dose / therapist attention / no introductory call<br>Will receive standard dose intervention content, therapist-based attention to elevated symptoms, and no introductory call from a therapist. | Behavioral: Mobile mindfulness-based training<br>* The intervention core is a mobile app-based mindfulness training program designed to be used over a 1-month period. All 8 factorial groups will use the app, though the delivery of the app and response to psychological distress symptoms over time will differ by group.<br>|
| Experimental: Standard dose / app attention / introductory call<br>Will receive standard dose intervention content, app-based attention to elevated symptoms, and an introductory call from a therapist. | Behavioral: Mobile mindfulness-based training<br>* The intervention core is a mobile app-based mindfulness training program designed to be used over a 1-month period. All 8 factorial groups will use the app, though the delivery of the app and response to psychological distress symptoms over time will differ by group.<br>|
| Experimental: Standard dose / app attention / no introductory call<br>Will receive standard dose intervention content, app-based attention to elevated symptoms, and no introductory call from a therapist. | Behavioral: Mobile mindfulness-based training<br>* The intervention core is a mobile app-based mindfulness training program designed to be used over a 1-month period. All 8 factorial groups will use the app, though the delivery of the app and response to psychological distress symptoms over time will differ by group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Health Questionnaire-9 Item scale (PHQ-9) | Depression symptoms. Scores range from 0 (better) to 27 (worse) | Between baseline and 1 month post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Health Questionnaire-9 Item scale (PHQ-9) | Depression symptoms. Scores range from 0 (better) to 27 (worse) | Between baseline 3 months post-randomization | 
| Change in Generalized Anxiety Disorder 7-item scale (GAD-7) | Anxiety symptoms. Scores range from 0 (better) to 21 (worse) | Between baseline 3 months post-randomization | 
| Change in Post-Traumatic Stress Symptom inventory (PTSS) | PTSD symptoms. Scores can range from 10 (best) to 70 (worst). | Between baseline 3 months post-randomization | 
| Intervention adherence | Quantified by number of intervention sessions, weekly surveys, and intervention elements (e.g., videos, audio) completed. | 1 month post-randomization | 
| Intervention adherence | Quantified by number of intervention sessions, weekly surveys, and intervention elements (e.g., videos, audio) completed. | 3 months post-randomization | 
| Client Satisfaction Questionnaire (CSQ) | A measure of acceptability. Scores can range from 8 (worst) to 32 (best) | 3 months post-randomization | 
| Systems Usability Scale (SUS) | 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) | 3 months post-randomization | 
| Change in Mindful Attention Awareness Scale (MAAS) | A measure of mindfulness qualities. Scores can range from 5 (worst) to 30 (best). | Between baseline and 1 month post-randomization | 
| Change in Mindful Attention Awareness Scale (MAAS) | A measure of mindfulness qualities. Scores can range from 5 (worst) to 30 (best). | Between baseline 3 months post-randomization | 
| Change in Patient Health Questionnaire 10-item scale (PHQ-10) | An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 10 (best) to 20 (worst). | Between baseline and 1 month post-randomization | 
| Change in Patient Health Questionnaire 10-item scale (PHQ-10) | An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 10 (best) to 20 (worst). | Between baseline 3 months post-randomization | 
| Change in EuroQOL scale | A measure of quality of life. An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 0 (worst) to 100 (best) | Between baseline and 1 month post-randomization | 
| Change in EuroQOL scale | A measure of quality of life. Scores can range from 0 (worst) to 100 (best) | Between baseline 3 months post-randomization | 
| Distress associated with depression symptom frequency | 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) | Between baseline and 1 month post-randomization | 
| Distress associated with depression symptom frequency | 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) | Between baseline 3 months post-randomization | 
| Distress associated with anxiety symptom frequency | 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) | Between baseline and 1 month post-randomization | 
| Distress associated with anxiety symptom frequency | 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) | Between baseline 3 months post-randomization | 
| Distress associated with PTSD symptom frequency | 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) | Between baseline and 1 month post-randomization | 
| Distress associated with PTSD symptom frequency | 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) | Between baseline 3 months post-randomization | 
| Change in Generalized Anxiety Disorder 7-item scale (GAD-7) | Anxiety symptoms. Scores range from 0 (better) to 21 (worse) | Between baseline and 1 month post-randomization | 
| Change in Post-Traumatic Stress Symptom inventory (PTSS) | Post-traumatic stress disorder symptoms. Scores can range from 10 (best) to 70 (worst). | Between baseline and 1 month post-randomization | 
| Client Satisfaction Questionnaire (CSQ) | A measure of acceptability. Scores can range from 8 (worst) to 32 (best) | 1 month post-randomization | 
| Systems Usability Scale (SUS) | 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) | 1 month post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiorespiratory failure, critical illness, psychological distress, depression, anxiety, post-traumatic stress disorder, intensive care units, adults, mechanical ventilation