Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06538246

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Duke University Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

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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

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