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N/A N=247 Randomized Double-blind Supportive Care

Optimizing a Mobile Mindfulness Intervention for ICU Survivors

Cardiorespiratory Failure

Enrolled (actual)
247
Serious AEs
10.1%
Results posted
Aug 2024
Primary outcome: Primary: Patient Health Questionnaire-9 Item Scale (PHQ-9) — 6.2; 6.4; 7.0; 5.6 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Mobile mindfulness-based training (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Duke University
Primary completion
May 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Patient Health Questionnaire-9 Item Scale (PHQ-9)
7.28; 7.04; 8.12; 6.10; 6.73; 7.55
SECONDARY
Generalized Anxiety Disorder 7-item Scale (GAD-7)
5.62; 5.69; 6.83; 4.38; 6.25; 5.11
SECONDARY
Patient Health Questionnaire-9 Item Scale (PHQ-9)
7.28; 7.04; 8.12; 6.10; 6.73; 7.55
SECONDARY
Generalized Anxiety Disorder 7-item Scale (GAD-7)
5.62; 5.69; 6.83; 4.38; 6.25; 5.11
SECONDARY
Post-Traumatic Stress Symptom Inventory (PTSS)
28.91; 26.38; 31.53; 23.65; 29.53; 25.77
SECONDARY
Intervention Adherence: Activity in App During Final Week of Intervention
105; 108; 112; 104; 105; 111
SECONDARY
Intervention Adherence: Number of Views of Content
34.24; 40.03; 34.88; 39.38; 40.53; 33.70
SECONDARY
Client Satisfaction Questionnaire (CSQ)
25.27; 25.31; 24.86; 25.71; 25.81; 24.79
SECONDARY
Systems Usability Scale (SUS)
SECONDARY
Mindful Attention Awareness Scale (MAAS)
22.43; 23.03; 22.43; 23.08; 22.57; 22.90
SECONDARY
Mindful Attention Awareness Scale (MAAS)
22.43; 23.03; 22.43; 23.08; 22.57; 22.90
SECONDARY
Patient Health Questionnaire 10-item Scale (PHQ-10)
6.21; 5.63; 6.15; 5.64; 5.85; 5.96
SECONDARY
Patient Health Questionnaire 10-item Scale (PHQ-10)
6.21; 5.63; 6.15; 5.64; 5.85; 5.96
SECONDARY
EuroQOL Scale
61.56; 63.60; 58.87; 66.56; 63.91; 61.43
SECONDARY
Change in EuroQOL Scale
62.07; 65.47; 61.68; 66.21; 65.02; 62.74
SECONDARY
Distress Associated With Depression Symptom Frequency
41.22; 37.40; 44.26; 34.02; 41.34; 37.25
SECONDARY
Distress Associated With Depression Symptom Frequency
41.22; 37.40; 44.26; 34.02; 41.34; 37.25
SECONDARY
Distress Associated With Anxiety Symptom Frequency
SECONDARY
Distress Associated With Anxiety Symptom Frequency
SECONDARY
Distress Associated With PTSD Symptom Frequency
SECONDARY
Distress Associated With PTSD Symptom Frequency
SECONDARY
Post-Traumatic Stress Symptom Inventory (PTSS)
28.91; 26.38; 31.53; 23.65; 29.53; 25.77
SECONDARY
Client Satisfaction Questionnaire (CSQ)
25.27; 25.31; 24.86; 25.71; 25.81; 24.79
SECONDARY
Systems Usability Scale (SUS)

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04038567). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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