Conditions treated in intensive care units (ICUs) such as the acute respiratory distress syndrome (ARDS), congestive heart failure, COVID pneumonia, and sepsis are common. These can lead to high rates of depression, anxiety, and PTSD that worsen quality of life. Yet there are few effective strategies able to overcome barriers of limited access to mental health care. Even less is known about the experiences of patients from racially and ethnically minoritized populations because of they haven't been included well in past research.
To address this problem, the investigators developed Blueprint, a mobile app that coaches people to use adaptive coping skills to self-manage their symptoms. The investigators found that it reduced depression symptoms and improved quality of life compared to placebo.
To confirm these promising findings, the investigators are doing a formal test of Blueprint. The investigators will enroll 400 people who received ICU care from 4 hospitals (Duke, UCLA, Colorado, and Oregon). These patients will be randomized to receive either the Blueprint mobile app or a special Education Program mobile app the investigators developed. -both delivered through similar mobile app platforms. Our specific aims are to see which program improves symptoms better across 6 months of follow up.
This project addresses national research priorities and could advance the field with a personalizable yet population-focused therapy that could be scaled broadly and efficiently to enhance mental health equity.
Adult (age ≥18)
Managed in an ICU or stepdown unit for ≥24 hours during the time inclusion criterion #3 is met
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
Active alcohol or drug abuse (e.g., admission for alcohol withdrawal, drug-related complication, positive toxicology screening at admission, endorsement of active addiction)
Anticipated surgical procedures
Anticipated complex medical regiment (e.g., new chemotherapy, new dialysis, need for repeat surgery, pregnant and near term)
Plan for comfort care
Parallel
Blueprint
BehavioralThis is a mobile app-based adaptive coping skills intervention that lasts 1 month
Education program
BehavioralThis is a mobile app-based education program that lasts 1 month
Hospital Anxiety and Depression Scale (HADS)
The HADS evaluates anxiety (7 items) and depression (7 items) with a 14-item instrument assessing symptoms on a 4-point scale rated from 0 "not at all" to 3 "very often indeed". It has a score range of 0 to 42 with higher scores indicating more symptoms.
Post-Traumatic Stress Syndrome inventory (PTSS)
The PTSS rates 10 post-traumatic stress symptoms and has a score range of 10 (no symptoms) to 70 (high burden of symptoms).
EuroQOL-5D visual analog scale (EQ VAS) quality of life measure
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' (100) and 'Worst imaginable health state' (0). The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Perceived Stress Scale 4-Item survey (PSS-4)
This is a 4-item short version of the PSS. Scores can range from 0 (lowest stress) to 16 (highest level of stress)
Patient Health Questionnaire 10-Item symptoms scale (PHQ-10)
The PHQ-10 is an adapted version of the PHQ-15, a measure of physical symptoms. Scores can range from 0 (best) to 30 (worst).
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
Oregon Health and Science University
Collaborator
University of Colorado, Denver
Collaborator
University of California, Los Angeles
Collaborator
