Status:
RECRUITING
Adaptive Coping Skills Training to Improve Psychological Distress Among Cardiorespiratory Failure Survivors
Lead Sponsor:
Duke University
Collaborating Sponsors:
Oregon Health and Science University
University of Colorado, Denver
Conditions:
Depression
Anxiety
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Cardiorespiratory conditions such as the acute respiratory distress syndrome (ARDS), congestive heart failure, COVID pneumonia, and sepsis are among the most common causes of mortality and morbidity. ...
Eligibility Criteria
Inclusion
- Inclusion Criteria Inclusion criteria present in the hospital
- 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:
- 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
- new use of supplemental oxygen ≥6 liters per minute (or increase in baseline continuous oxygen)
- use of vasopressors for shock of any etiology
- use of inotropes for shock of any etiology
- use of pulmonary vasodilators
- use of aortic balloon pump or cardiac assist device for cardiogenic shock
- use of diuretic intravenous drip
- evidence of acute coronary ischemia (i.e., elevated troponin level, supporting EKG changes, unstable angina symptoms documented)
- urgent cardiac catheterization
- Cognitive status intact
- • No history of pre-existing significant cognitive impairment (e.g., dementia) as per medical chart
- Absence of severe mental illness
- Treatment for severe mental illness (e.g., psychosis, bipolar affective disorder, schizoaffective disorder, schizoid personality disorder, schizophrenia \[as per medical record\], hospitalization for any psychiatric disorder) within the 6 months preceding the current hospital admission
- Evidence of poorly managed severe mental illness
- No endorsement of suicidality at time of admission or informed consent
- Functional fluency in English or Spanish (i.e., sufficient knowledge of English or Spanish to complete study tasks like watch videos, complete surveys)
- Inclusion criteria present after hospital discharge (i.e., at the time of arrival home after discharge from the hospital)
- 1\. Elevated baseline psychological distress symptoms, defined as a Hospital Anxiety and Distress Scale (HADS) total score ≥8
- Exclusion Criteria Exclusion criteria present in the hospital
- 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:
- 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
- Other complex needs anticipated that could interfere with the ability to complete study procedures. Examples include:
- Anticipated disruptive travel
- Inability to use mobile app
- Anticipated unstable living situation
- 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
- Previously enrolled in the trial
- Exclusion criteria present after hospital discharge (i.e., at T1 Data Collection conducted at the time of arrival home from the hospital)
- Failure to randomize within 14 days from planned start date (planned start date is within 3 days post-discharge from the hospital to home to accommodate weekends)
- Readmission to hospital before randomization completed
Exclusion
Key Trial Info
Start Date :
October 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 15 2028
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06538246
Start Date
October 15 2024
End Date
April 15 2028
Last Update
December 5 2025
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710