Mobile App-Based Adaptive Coping Skills Training to Reduce Psychological Distress After Serious Cardiorespiratory Illness in Adults
Led by Duke University · Updated on 2026-07-23
400
Participants Needed
1
Research Sites
21 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a mobile app-based adaptive coping skills training called Blueprint for adults who have survived serious cardiorespiratory illnesses such as acute respiratory distress syndrome ARDS, congestive heart failure, COVID pneumonia, and sepsis. These conditions often lead to persistent psychological distress including depression, anxiety, and PTSD, which negatively impact quality of life. The study focuses especially on racially and ethnically minoritized populations who have been underrepresented in past research.
Participants will be randomly assigned to one of two groups one using the Blueprint app which delivers adaptive coping skills over four weeks, and the other using a specially developed Education Program app with condition-specific informational videos. Both interventions include weekly safety monitoring surveys and complementary printed or PDF workbooks. The study will follow participants for six months after enrollment to compare the effects of these two programs.
During the study, participants will use the assigned mobile app and complete surveys at baseline, 1 month, 3 months, and 6 months post-randomization to measure symptoms of depression, anxiety, PTSD, stress, and quality of life. The researchers will monitor safety through weekly surveys within the apps and collect data to understand who benefits most from the programs. The total participation duration includes the initial 4-week intervention and six months of follow-up assessments.
CONDITIONS
Brief Title
Adaptive Coping Skills Training to Improve Psychological Distress Among Cardiorespiratory Failure Survivors
Research Team
C
Christopher Cox
K
Kristy Johnson
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Blueprint coping app
Education app
What it is
A month-long adaptive coping skills program for survivors of cardiorespiratory failure, delivered via a self-guided mobile app, aiming to build resilience and alleviate psychological distress.
A one-month education program using a mobile app that provides health-related information to critical illness survivors, but does not include coping skills training.
Role in trial
Investigational treatment arm testing whether an adaptive coping skills app improves symptoms of depression, anxiety, and stress among recently discharged cardiorespiratory failure survivors.
Active comparator arm delivering general education without adaptive coping skills, used to compare outcomes with the investigational app.
Primary use
Intended to decrease symptoms of depression, anxiety, and stress, and support adaptation after ICU or acute cardiorespiratory failure.
Designed to improve knowledge about health and recovery after critical illness, without delivering active psychological coping training.
How it is given or performed
Delivered as a self-guided, mobile app-based program over one month, which participants use independently at home.
Participants receive access to a mobile app for one month, delivering educational and health content for self-directed learning.
Evidence status
Efficacy of this coping skills app for critical illness survivors is currently under investigation. Similar digital interventions, including mindfulness or coping apps, have shown mixed improvements in psychological distress in post-ICU populations.
Educational programs for ICU or cardiorespiratory failure survivors show limited evidence for reducing psychological distress, but may improve illness understanding and engagement.
Important limitations
The full impact and durability of mental health benefits are still unproven. Effectiveness may depend on engagement with the app, and not all participants may benefit equally. Most evidence comes from small trials or pilot studies.
General education apps may not actively address distress or psychological symptoms. Engagement and personal relevance might be lower than for personalized behavioral interventions. Existing studies often use such arms as controls rather than as effective treatments.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Adults aged 18 years or older
Managed in an ICU or stepdown unit for at least 24 hours during hospitalization
Diagnosed with a serious acute cardiorespiratory condition such as mechanical ventilation for 4 hours or more, non-invasive ventilation for 4 hours, new use or increase of supplemental oxygen at 6 liters per minute or more, use of vasopressors, inotropes, pulmonary vasodilators, cardiac assist devices, intravenous diuretics, evidence of acute coronary ischemia, or urgent cardiac catheterization
Intact cognitive status with no history of significant cognitive impairment like dementia
No severe mental illness treatment or hospitalization in the past 6 months and no current suicidality
Functional fluency in English or Spanish to complete study tasks
Elevated psychological distress symptoms with a Hospital Anxiety and Depression Scale (HADS) score of 8 or higher after hospital discharge
You will not qualify if you...
Active alcohol or drug abuse or withdrawal at admission
Anticipated complex medical needs after discharge such as surgery, chemotherapy, dialysis, or comfort care plans
Anticipated disruptive travel, inability to use mobile app, or unstable living situation interfering with study
Discharge planned to locations other than independent home (e.g., nursing home, rehabilitation facility, hospice)
Persistently impaired cognition defined by errors on cognitive screening or lack of decisional capacity
Currently imprisoned, incarcerated, or under home detention
Lack of reliable smartphone with cellular data or internet access
Participation in another conflicting intervention study
Previous enrollment in this trial
Failure to randomize within 14 days from planned start date after discharge
Readmission to hospital before randomization completed
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 4 weeks
Participants use either the Blueprint adaptive coping skills app or the Education Program app for 4 weeks. Each week includes safety monitoring surveys and access to complementary printed or PDF materials with videos.
Weekly app sessions with safety surveys
Follow-up
Duration - 6 months
Participants complete surveys at 1 month, 3 months, and 6 months after starting the program to assess symptoms of depression, anxiety, PTSD, stress, and quality of life.
3 follow-up assessments
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
Effects of mindfulness training programmes delivered by a self-directed mobile app and by telephone compared with an education programme for survivors of critical illness: a pilot randomised clinical trial.
Christopher E Cox, Catherine L Hough, Derek M Jones...
Blueprint 2: A self-directed mobile adaptive coping skills intervention to improve psychological distress symptoms among cardiorespiratory failure survivors study protocol.
Robin L Baudier, Katie E Mosack, Jodi A Lapidus...