N/A
Completed N=45
Mobile Coping Skills Training to Improve Cardiorespiratory Failure Survivors' Psychological Distress
Cardiorespiratory Failure
Source: ClinicalTrials.gov NCT04329702 ↗
Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcomePrimary: Change in Hospital Anxiety and Depression Scale (HADS) Questionnaire — 11.7; 11.3; 12.1 units on a scale
Summary
This is a pilot randomized clinical trial involving adult survivors of cardiorespiratory failure treated in intensive care units (ICUs) that is designed to test the acceptability, feasibility, and clinical impact of a coping skills training intervention (Blueprint) delivered via a mobile app. This trial will allow us to determine if new changes to intervention delivery, inclusion criteria, and other factors are successful. It will also inform the development of a next-step efficacy focused trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hospital Anxiety and Depression Scale (HADS) Questionnaire |
11.0; 11.4; 13.5 | — |
| SECONDARY Change in Hospital Anxiety and Depression Scale (HADS) Questionnaire |
11.0; 11.4; 13.5 | — |
| SECONDARY Change in Post-Traumatic Stress Symptom Inventory (PTSS) |
28.9; 29.4; 31.3 | — |
| SECONDARY Client Satisfaction Questionnaire (CSQ) |
29; 29.5; 25 | — |
| SECONDARY Intervention Adherence |
36.5; 34.1 | — |
| SECONDARY Change in Quality of Life Visual Analog Scale |
61.4; 72.5; 67.1 | — |
| SECONDARY Patient Health Questionnaire 10-item Scale (PHQ-10) |
7.9; 6.5; 5.7 | — |
| SECONDARY Distress Associated With Depression and Anxiety Symptom Frequency |
— | — |
| SECONDARY Distress Associated With PTSD Symptom Frequency |
— | — |
Eligibility Criteria
INCLUSION CRITERIA
- Adult (age ≥18)
- Managed in a hospital setting for ≥24 hours during the time inclusion criterion #3 is met.
- Acute cardiorespiratory failure / insufficiency, defined as ≥1 of the following:
- mechanical ventilation via endotracheal tube for ≥4 hours
- non-invasive ventilation (CPAP, BiPAP) for ≥4 hours in a 24-hour period provided for acute respiratory failure
- new use of supplemental oxygen ≥2 liters per minute (or increase in baseline continuous oxygen)
- use of vasopressors for shock of any etiology
- use of inotropes for shock of any etiology
- use of pulmonary vasodilators
- use of aortic balloon pump or cardiac assist device for cardiogenic shock
- use of diuretic intravenous drip
- 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 active suicidality at time of admission or informed consent
- No active substance abuse at a severity that impairs ability to participate
- Functional English fluency
EXCLUSION CRITERIA (in hospital):
- Complex medical care expected soon after discharge (e.g., planned surgeries, transplantation evaluation, extensive travel needs for follow up care, disruptive chemotherapy/radiation regimen)
- Unable to complete study procedures as determined by staff
- Lack of access to either reliable smartphone with cellular data plan or wifi
INCLUSION CRITERIA (post-discharge)
- Elevated baseline (T1) psychological distress symptoms, defined as HADS total score of ≥8
EXCLUSION CRITERIA (post-discharge)
- Failure to randomize within 2 months post-discharge.
- Failure to access app within 1 month after randomization in the absence of other explanation (e.g., hospitalization).
Data sourced from ClinicalTrials.gov (NCT04329702). 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. Informational only — not medical advice.