Self-directed Mobile Adaptive Coping Skills Intervention to Improve Psychological Distress Symptoms Among Cardiorespiratory Failure Survivors: Blueprint 2

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

∙ 1\. Elevated baseline psychological distress symptoms, defined as a Hospital Anxiety and Distress Scale (HADS) total score ≥8

Locations
United States
North Carolina
Duke University Medical Center
RECRUITING
Durham
Contact Information
Primary
Christopher Cox
christopher.cox@duke.edu
919-681-7232
Backup
Allison Johnson
allison.johnson@duke.edu
Time Frame
Start Date: 2024-10-15
Estimated Completion Date: 2028-04-15
Participants
Target number of participants: 400
Treatments
Experimental: Blueprint adaptive coping skills intervention
This is a unique adaptive coping skills intervention developed over years of research that targets patients hospitalized for cardiorespiratory conditions. Participants will receive 4 weeks of different Blueprint content through a mobile app. Each week's session includes a within-app HADS survey for safety monitoring. A printed or PDF workbook with complementary content and QR links to app videos is provided.
Active_comparator: Education program control
This is cardiorespiratory condition-specific content through an iterative process, informed by research on informational needs and past successful education programs. Participants will receive 4 weeks of different 10-minute informational videos unrelated to Blueprint content through a mobile app. Each week's session includes a within-app HADS survey for safety monitoring. A printed or PDF workbook with complementary content and QR links to app videos is provided.
Sponsors
Leads: Duke University
Collaborators: Oregon Health and Science University, University of Colorado, Denver, University of California, Los Angeles

This content was sourced from clinicaltrials.gov