Optimizing a Mobile Mindfulness Intervention for ICU Survivors
Cardiorespiratory Failure
Bottom Line
View on ClinicalTrials.gov: NCT04038567 ↗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
| Outcome | Result | p-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
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.
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.