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

NCT06538246 | Recruiting DMC

• 1 other identifier: Pro00115623
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety and Depression Scale (HADS)

  The HADS evaluates anxiety (7 items) and depression (7 items) with a 14-item instrument assessing symptoms on a 4-point scale rated from 0 "not at all" to 3 "very often indeed". It has a score range of 0 to 42 with higher scores indicating more symptoms.

  Baseline, 1 month, 3 months, and 6 months post-randomization

Secondary Outcomes (3)

• Post-Traumatic Stress Syndrome inventory (PTSS)

  Baseline, 1 month, 3 months, and 6 months post-randomization

• EuroQOL-5D visual analog scale (EQ VAS) quality of life measure

  Baseline, 1 month, 3 months, and 6 months post-randomization

• Perceived Stress Scale 4-Item survey (PSS-4)

  Baseline, 1 month, 3 months, and 6 months post-randomization

Other Outcomes (1)

• Patient Health Questionnaire 10-Item symptoms scale (PHQ-10)

  Baseline, 1 month, 3 months, and 6 months post-randomization

Study Arms (2)

Blueprint adaptive coping skills intervention

EXPERIMENTAL

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.

Behavioral: Blueprint

Education program control

ACTIVE COMPARATOR

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.

Behavioral: Education program

Interventions

Blueprint BEHAVIORAL

This is a mobile app-based adaptive coping skills intervention that lasts 1 month

Blueprint adaptive coping skills intervention

Education program BEHAVIORAL

This is a mobile app-based education program that lasts 1 month

Education program control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (age ≥18)
• 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

You may not qualify if:

• Active alcohol or drug abuse (e.g., admission for alcohol withdrawal, drug-related complication, positive toxicology screening at admission, endorsement of active addiction)
• 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
• 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
• 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)
• 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)
• Currently imprisoned or incarcerated or in home detention
• Lack a reliable smartphone with cellular data plan or access to the internet
• Currently enrolled in another study involving an intervention whose objectives conflict with the objectives of this study
• Previously enrolled in the trial

Sponsors & Collaborators

• Duke University: lead
• University of Colorado, Denver: collaborator
• University of California, Los Angeles: collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Related Publications (2)

• Cox CE, Gallis JA, Olsen MK, Porter LS, Gremore T, Greeson JM, Morris C, Moss M, Hough CL. Mobile Mindfulness Intervention for Psychological Distress Among Intensive Care Unit Survivors: A Randomized Clinical Trial. JAMA Intern Med. 2024 Jul 1;184(7):749-759. doi: 10.1001/jamainternmed.2024.0823.

  PMID: 38805199 RESULT

• Cox CE, Hough CL, Jones DM, Ungar A, Reagan W, Key MD, Gremore T, Olsen MK, Sanders L, Greeson JM, Porter LS. Effects of mindfulness training programmes delivered by a self-directed mobile app and by telephone compared with an education programme for survivors of critical illness: a pilot randomised clinical trial. Thorax. 2019 Jan;74(1):33-42. doi: 10.1136/thoraxjnl-2017-211264. Epub 2018 May 23.

  PMID: 29793970 RESULT

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic; Pain; Dyspnea

Interventions

Blueprint Asept; Early Intervention, Educational

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Christopher Cox

  Professor of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Cox

CONTACT

919-681-7232; christopher.cox@duke.edu

Kristy Johnson

CONTACT

kristy.johnson@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators will be blinded to group assignment and survey results. Survey results will be reported by the participants via their mobile apps, and so will not be visible to anyone.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 5, 2024
• Study Start: October 15, 2024
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): April 15, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Per NIH guidelines
• Access Criteria: To be determined

Locations

US (1)