Optimizing a Mobile Mindfulness Intervention for ICU Survivors (LIFT2)

Duke University

Status: Completed

Conditions: Cardiorespiratory Failure

Treatments: Behavioral: Mobile mindfulness-based training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04038567

Pro00100252

1U01AT009974 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 247 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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247 participants in 6 patient groups

App introduction to intervention

Other group

Description:

Introduction to intervention via the mobile app itself.

Treatment:

Behavioral: Mobile mindfulness-based training

Therapist introduction to intervention

Other group

Description:

Introduction to intervention via a call from the study therapist.

Treatment:

Behavioral: Mobile mindfulness-based training

Standard dose

Other group

Description:

Standard dose of meditation time (once a day).

Treatment:

Behavioral: Mobile mindfulness-based training

High dose

Other group

Description:

High dose of meditation time (twice a day).

Treatment:

Behavioral: Mobile mindfulness-based training

App response to symptoms

Other group

Description:

Mobile app response to elevated psychological distress symptoms during intervention period.

Treatment:

Behavioral: Mobile mindfulness-based training

Therapist response to symptoms

Other group

Description:

Therapist call in response to elevated psychological distress symptoms during intervention period.

Treatment:

Behavioral: Mobile mindfulness-based training