Actively Recruiting
Adaptive Coping Skills Training to Improve Psychological Distress Among Cardiorespiratory Failure Survivors
Led by Duke University · Updated on 2026-03-06
400
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
O
Oregon Health and Science University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adaptive Coping Skills Training to Improve Psychological Distress Among Cardiorespiratory Failure Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult aged 18 years or older
- Managed in an ICU or stepdown unit for 24 hours or more
- Serious acute cardiorespiratory condition including at least one of: mechanical ventilation for 4+ hours, non-invasive ventilation for 4+ hours in 24 hours, new or increased supplemental oxygen (6+ liters per minute), use of vasopressors, inotropes, pulmonary vasodilators, cardiac assist devices, intravenous diuretics, acute coronary ischemia, or urgent cardiac catheterization
- Intact cognitive status with no history of significant cognitive impairment
- No severe mental illness or recent psychiatric hospitalization, no current suicidality
- Functional fluency in English or Spanish
- Elevated psychological distress symptoms with Hospital Anxiety and Depression Scale total score of 8 or more after hospital discharge
You will not qualify if you...
- Active alcohol or drug abuse or related complications
- Anticipated complex medical needs post-discharge such as new surgery, chemotherapy, dialysis, or comfort care
- Other complex needs interfering with study participation, including disruptive travel or inability to use the app
- Expected discharge to non-independent living settings like nursing homes or rehabilitation facilities
- Persistently impaired cognition or lack of decisional capacity
- Currently imprisoned, incarcerated, or under home detention
- Lack of a reliable smartphone with cellular data or internet access
- Currently enrolled in conflicting intervention studies
- Previous enrollment in this trial
- Failure to randomize within 14 days of planned start date after hospital discharge
- Readmission to hospital before randomization is completed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
C
Christopher Cox
CONTACT
K
Kristy Johnson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here