RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-15
Study Completion:2028-04-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06538246

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Christopher Cox
CONTACT
919-681-7232
christopher.cox@duke.edu
Allison Johnson
CONTACT
allison.johnson@duke.edu

Principal Investigator

Christopher Cox
PRINCIPAL_INVESTIGATOR
Professor of Medicine

Study Locations (Sites)

Duke University Medical Center
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Duke University

  • Christopher Cox, PRINCIPAL_INVESTIGATOR, Professor of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-15
Study Completion Date2028-04-15

Study Record Updates

Study Start Date2024-10-15
Study Completion Date2028-04-15

Terms related to this study

Additional Relevant MeSH Terms

  • Depression
  • Anxiety
  • Post-traumatic Stress Disorder
  • Stress
  • Worries; Pain or Disability
  • Breath Shortness