Mobile app training to help ICU survivors manage psychological distress
Self-directed Mobile Adaptive Coping Skills Intervention to Improve Psychological Distress Symptoms Among Cardiorespiratory Failure Survivors: Blueprint 2
This study is testing a mobile app that helps ICU survivors learn coping skills to see if it can reduce their feelings of anxiety, depression, and PTSD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06538246 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Blueprint, a mobile app designed to teach adaptive coping skills to individuals recovering from serious cardiorespiratory conditions. The app aims to reduce psychological distress symptoms such as depression, anxiety, and PTSD, which are common among ICU survivors. The trial will enroll 400 participants from four hospitals, including Duke University, UCLA, and others, to formally test the app's impact on mental health outcomes. The study addresses the lack of effective mental health strategies for racially and ethnically minoritized populations who have been underrepresented in previous research.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been managed in an ICU for at least 24 hours due to serious acute cardiorespiratory conditions.
Not a fit: Patients who do not have intact cognitive status or who were not managed in an ICU for the required duration may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental health and quality of life for ICU survivors dealing with psychological distress.
How similar studies have performed: Previous studies have shown promising results with similar mobile app interventions for mental health, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Christopher Cox — Professor of Medicine
- Study coordinator: Christopher Cox
- Email: christopher.cox@duke.edu
- Phone: 919-681-7232
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.