Clinical trial NCT04038567: Optimizing a Mobile Mindfulness Intervention for ICU Survivors
Official title: Optimizing a Self-directed Mobile Mindfulness Intervention for Improving Cardiorespiratory Failure Survivors' Psychological Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiorespiratory Failure
Keywords: cardiorespiratory failure
critical illness
psychological distress
depression
anxiety
post-traumatic stress disorder
intensive care units
adults
mechanical ventilation
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of Washington
name: University of Colorado, Denver
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-07-31
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Factorial experimental trial as part of a multi-phase optimization strategy (MOST) design
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: INCLUSION CRITERIA

1. Adult (age ≥18)
2. 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
3. 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.
4. 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
5. 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.
6. English fluency.

EXCLUSION CRITERIA (in hospital):

1. 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.
2. Admitted from a location other than home (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility)
3. 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)
4. Complex medical care expected soon after discharge (e.g., planned surgeries, transplantation evaluation, extensive travel needs for hemodialysis, disruptive chemotherapy/radiation regimen)
5. Unable to complete study procedures as determined by staff
6. Lack of reliable smartphone with cellular data plan or wifi access

   EXCLUSION CRITERIA (at T1, post-discharge):
7. Low baseline psychological distress symptoms, defined as the absence of the following at T1: PHQ-9 score \<5
8. Failure to randomize within 2 month (60 days) post-discharge.

Primary outcomes:
measure: Patient Health Questionnaire-9 Item Scale (PHQ-9)
timeFrame: 1 month post-randomization
Secondary outcomes:
measure: Generalized Anxiety Disorder 7-item Scale (GAD-7)
timeFrame: Between baseline 1 month post-randomization
measure: Patient Health Questionnaire-9 Item Scale (PHQ-9)
timeFrame: Between baseline 3 months post-randomization
measure: Generalized Anxiety Disorder 7-item Scale (GAD-7)
timeFrame: Between baseline 3 months post-randomization
measure: Post-Traumatic Stress Symptom Inventory (PTSS)
timeFrame: Between baseline 3 months post-randomization
measure: Intervention Adherence: Activity in App During Final Week of Intervention
timeFrame: 1 month post-randomization
measure: Intervention Adherence: Number of Views of Content
timeFrame: 1 month post-randomization
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 3 months post-randomization
measure: Systems Usability Scale (SUS)
timeFrame: 3 months post-randomization
measure: Mindful Attention Awareness Scale (MAAS)
timeFrame: Between baseline and 1 month post-randomization
measure: Mindful Attention Awareness Scale (MAAS)
timeFrame: Between baseline 3 months post-randomization
measure: Patient Health Questionnaire 10-item Scale (PHQ-10)
timeFrame: Between baseline and 1 month post-randomization
measure: Patient Health Questionnaire 10-item Scale (PHQ-10)
timeFrame: Between baseline 3 months post-randomization
measure: EuroQOL Scale
timeFrame: Between baseline and 1 month post-randomization
measure: Change in EuroQOL Scale
timeFrame: Between baseline 3 months post-randomization
measure: Distress Associated With Depression Symptom Frequency
timeFrame: Between baseline and 1 month post-randomization; THIS WAS NOT RECORDED
measure: Distress Associated With Depression Symptom Frequency
timeFrame: At 1 month post-randomization
measure: Distress Associated With Anxiety Symptom Frequency
timeFrame: At 1 month post-randomization
measure: Distress Associated With Anxiety Symptom Frequency
timeFrame: Between baseline 3 months post-randomization
measure: Distress Associated With PTSD Symptom Frequency
timeFrame: At 1 month post-randomization
measure: Distress Associated With PTSD Symptom Frequency
timeFrame: At 3 months post-randomization
measure: Post-Traumatic Stress Symptom Inventory (PTSS)
timeFrame: Between baseline and 1 month post-randomization
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 1 month post-randomization
measure: Systems Usability Scale (SUS)
timeFrame: 1 month post-randomization
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado - Denver
state: Colorado
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Duke University
name: Christopher E Cox, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cox CE, Porter LS, Buck PJ, Hoffa M, Jones D, Walton B, Hough CL, Greeson JM. Development and preliminary evaluation of a telephone-based mindfulness training intervention for survivors of critical illness. Ann Am Thorac Soc. 2014 Feb;11(2):173-81. doi: 10.1513/AnnalsATS.201308-283OC.
citation: Cox CE, Hough CL, Jones DM, Ungar A, Reagan W, Key MD, Gremore T, Olsen MK, Sanders L, Greeson JM, Porter LS. Effects of mindfulness training programmes delivered by a self-directed mobile app and by telephone compared with an education programme for survivors of critical illness: a pilot randomised clinical trial. Thorax. 2019 Jan;74(1):33-42. doi: 10.1136/thoraxjnl-2017-211264. Epub 2018 May 23.
citation: Cox CE, Olsen MK, Gallis JA, Porter LS, Greeson JM, Gremore T, Frear A, Ungar A, McKeehan J, McDowell B, McDaniel H, Moss M, Hough CL. Optimizing a self-directed mobile mindfulness intervention for improving cardiorespiratory failure survivors' psychological distress (LIFT2): Design and rationale of a randomized factorial experimental clinical trial. Contemp Clin Trials. 2020 Sep;96:106119. doi: 10.1016/j.cct.2020.106119. Epub 2020 Aug 15.