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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06538246
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blueprint — BEHAVIORAL
    This is a mobile app-based adaptive coping skills intervention that lasts 1 month
  • Education program — BEHAVIORAL
    This is a mobile app-based education program that lasts 1 month

Study Details

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.

Key Dates

Start date
Oct 15, 2024
Status verified
Mar 2026
Primary completion
Nov 15, 2027
Completion
Apr 15, 2028

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline, 1 month, 3 months, and 6 months post-randomization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710
Kristy Johnson
[email protected]
Christopher Cox, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Durham, NC

By condition
DepressionPTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Duke University Medical Center· Durham, NC

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