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Behavioral Intervention

Blueprint adaptive coping skills intervention for Anxiety Disorder (Blueprint 2 Trial)

N/A
Waitlist Available
Led By Christopher Cox
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Inclusion Criteria Inclusion criteria present in the hospital
1. Adult (age ≥18)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 3 months, and 6 months post-randomization
Awards & highlights

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.

Who is the study for?
This trial is for survivors of cardiorespiratory failure who have been in the ICU and are experiencing psychological distress such as depression, anxiety, or PTSD. It's particularly focused on including patients from racially and ethnically minoritized groups.
What is being tested?
The study tests a mobile app called Blueprint that teaches adaptive coping skills to manage symptoms against an Education Program app. Both apps aim to improve mental health over six months, with participants randomly assigned to one of the two.
What are the potential side effects?
Since this trial involves psychological interventions through mobile apps rather than medications, traditional side effects are not expected. However, users may experience discomfort or emotional distress when engaging with their symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 3 months, and 6 months post-randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 3 months, and 6 months post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hospital Anxiety and Depression Scale (HADS)
Secondary study objectives
EuroQOL-5D visual analog scale (EQ VAS) quality of life measure
Perceived Stress Scale 4-Item survey (PSS-4)
Post-Traumatic Stress Syndrome inventory (PTSS)
Other study objectives
Patient Health Questionnaire 10-Item symptoms scale (PHQ-10)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Blueprint adaptive coping skills interventionExperimental Treatment1 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.
Group II: Education program controlActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blueprint
2019
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

University of Colorado, DenverOTHER
1,776 Previous Clinical Trials
2,774,689 Total Patients Enrolled
Duke UniversityLead Sponsor
2,408 Previous Clinical Trials
3,061,394 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
991 Previous Clinical Trials
7,385,980 Total Patients Enrolled
~267 spots leftby Nov 2027