Adaptive Coping Skills Training to Improve Psychological Distress Among Cardiorespiratory Failure Survivors

Launched by DUKE UNIVERSITY · Jul 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new mobile app called Blueprint, designed to help patients who have survived serious breathing or heart-related issues manage their mental health better. Many patients who have been in intensive care units (ICUs) struggle with depression, anxiety, and stress after their illness, which can make their recovery harder. The Blueprint app teaches users coping skills to reduce these symptoms and improve their overall quality of life. In this study, 400 participants from four hospitals will be randomly assigned to either use the Blueprint app or another educational app, and their progress will be monitored over six months.

To join the trial, individuals must be at least 18 years old and have stayed in an ICU for over 24 hours due to serious breathing or heart problems. They should also have some signs of psychological distress after leaving the hospital. Participants need to be able to understand and use the app, which is available in English and Spanish, and they should not have severe mental health issues or certain complex medical needs that could interfere with the study. This research aims to find effective ways to provide mental health support to patients, especially those from diverse backgrounds who may not have had access to similar resources before.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria Inclusion criteria present in the hospital
• • 1. Adult (age ≥18)
• • 2. Managed in an ICU or stepdown unit for ≥24 hours during the time inclusion criterion #3 is met
• 3. 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
• • 4. Cognitive status intact
• • • No history of pre-existing significant cognitive impairment (e.g., dementia) as per medical chart
• • 5. 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
• • 6. 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
• • 1. Active alcohol or drug abuse (e.g., admission for alcohol withdrawal, drug-related complication, positive toxicology screening at admission, endorsement of active addiction)
• 2. 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
• 3. 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
• • 4. 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)
• • 5. 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)
• • 6. Currently imprisoned or incarcerated or in home detention
• • 7. Lack a reliable smartphone with cellular data plan or access to the internet
• • 8. Currently enrolled in another study involving an intervention whose objectives conflict with the objectives of this study
• • 9. 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)
• • 1. 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)
• • 2. Readmission to hospital before randomization completed