Adaptive Coping Skills Training to Improve Psychological Distress Among Cardiorespiratory Failure… (NCT06538246) | Clinical Trial Compass
RecruitingNot Applicable
Adaptive Coping Skills Training to Improve Psychological Distress Among Cardiorespiratory Failure Survivors
United States400 participantsStarted 2024-10-15
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult (age ≥18)
✓. Managed in an ICU or stepdown unit for ≥24 hours during the time inclusion criterion #3 is met
✓. Serious acute cardiorespiratory condition, defined as ≥1 of the following:
✓. Cognitive status intact
✓. Absence of severe mental illness
✓. Functional fluency in English or Spanish (i.e., sufficient knowledge of English or Spanish to complete study tasks like watch videos, complete surveys)
Exclusion criteria
✕. Active alcohol or drug abuse (e.g., admission for alcohol withdrawal, drug-related complication, positive toxicology screening at admission, endorsement of active addiction)
✕. Anticipated complex medical needs after discharge that would be disruptive to intervention and follow up; for example:
✕. Other complex needs anticipated that could interfere with the ability to complete study procedures. Examples include:
What they're measuring
1
Hospital Anxiety and Depression Scale (HADS)
Timeframe: Baseline, 1 month, 3 months, and 6 months post-randomization
✕. 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)
✕. Persistently impaired cognition as a result of illness (Impairment defined as ≥3 errors on the Callahan cognitive status screen and/or the lack of decisional capacity (i.e., patient could be consented by medical team for a procedure if necessary)
✕. Currently imprisoned or incarcerated or in home detention
✕. Lack a reliable smartphone with cellular data plan or access to the internet
✕. Currently enrolled in another study involving an intervention whose objectives conflict with the objectives of this study