Adaptive Coping Skills Training to Improve Psychological Distress Among Cardiorespiratory Failure Survivors (Blueprint 2)

March 4, 2026 updated by: Duke University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cardiorespiratory conditions such as the acute respiratory distress syndrome (ARDS), congestive heart failure, COVID pneumonia, and sepsis are among the most common causes of mortality and morbidity. They are also notable for high rates of persistent psychological distress symptoms including depression, anxiety, and PTSD that worsen quality of life and outcomes of the underlying conditions. Yet there are few effective strategies able to overcome barriers of limited access to mental health care. Even less is known about distress management among people from structurally disadvantaged backgrounds such as racially and ethnically minoritized populations because of their suboptimal representation in relevant clinical trials.

To fill this gap, the investigators developed Blueprint, an adaptive coping skills training intervention, and have optimized it over years of research. The investigators conducted a multicenter RCT (PCORI PFA 195) of a telephone- and web-based version among those recently hospitalized with serious cardiorespiratory conditions, finding that it reduced depression symptoms and improved quality of life among those with elevated baseline distress. Informed by lessons learned about intervention delivery and eligibility criteria, the investigators next conducted a single-center pilot RCT (R34 HL145387) that targeted a broader population and tested a completely automated, self-guided, symptom-responsive mobile app version of Blueprint. The investigators found excellent adherence and a strong effect on depression, anxiety, PTSD, and quality of life compared to control.

Given these promising findings, a formal test of the Blueprint adaptive coping skills training intervention's efficacy is needed. Therefore, the investigators propose a 5-year multicenter RCT with 6-month follow up in which 400 cardiorespiratory failure survivors with elevated symptoms of psychological distress post-discharge are randomized to either Blueprint or an Education Program control-both delivered through similar mobile app platforms. Our specific aims will: (1) Test Blueprint vs. control on symptoms of depression, anxiety, PTSD, and quality of life; (2) Determine patient-level characteristics associated with a great treatment response among sociodemographic subgroups of interest, also applying a heterogeneity of treatment effects analysis to identify other groups of clinical relevance; and (3) Ensure off-the-shelf intervention readiness for implementation by using an exploratory mixed-methods hybrid type 1 implementation framework analysis that integrates semi-structured interviews with trial participants and quantitative trial data from Aims 1 and 2.

Innovative elements include a fully automated mobile health delivery system that personalizes content in response to changes in symptom trajectories, a focus on racially and ethnically minoritized persons, the integration of a Spanish language intervention version, and strong community engagement. 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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • Christopher Cox, MD
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria Inclusion criteria present in the hospital

  1. Adult (age ≥18)
  2. Managed in an ICU or stepdown unit for ≥24 hours during the time inclusion criterion #3 is met

  3. 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

  4. Cognitive status intact

    • No history of pre-existing significant cognitive impairment (e.g., dementia) as per medical chart

  5. 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
  6. Functional fluency in English or Spanish (i.e., sufficient knowledge of English or Spanish to complete study tasks like watch videos, complete surveys)

Inclusion criteria present after hospital discharge (i.e., at the time of arrival home after discharge from the hospital)

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

Exclusion Criteria Exclusion criteria present in the hospital

  1. Active alcohol or drug abuse (e.g., admission for alcohol withdrawal, drug-related complication, positive toxicology screening at admission, endorsement of active addiction)

  2. 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

  3. 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
  4. 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)
  5. 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)
  6. Currently imprisoned or incarcerated or in home detention
  7. Lack a reliable smartphone with cellular data plan or access to the internet
  8. Currently enrolled in another study involving an intervention whose objectives conflict with the objectives of this study
  9. Previously enrolled in the trial

Exclusion criteria present after hospital discharge (i.e., at T1 Data Collection conducted at the time of arrival home from the hospital)

  1. Failure to randomize within 14 days from planned start date (planned start date is within 3 days post-discharge from the hospital to home to accommodate weekends)
  2. Readmission to hospital before randomization completed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Blueprint
This is a mobile app-based adaptive coping skills intervention that lasts 1 month
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.
Behavioral: Education program
This is a mobile app-based education program that lasts 1 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline, 1 month, 3 months, and 6 months post-randomization
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-Traumatic Stress Syndrome inventory (PTSS)
Time Frame: Baseline, 1 month, 3 months, and 6 months post-randomization
The PTSS rates 10 post-traumatic stress symptoms and has a score range of 10 (no symptoms) to 70 (high burden of symptoms).
Baseline, 1 month, 3 months, and 6 months post-randomization
EuroQOL-5D visual analog scale (EQ VAS) quality of life measure
Time Frame: Baseline, 1 month, 3 months, and 6 months post-randomization
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' (100) and 'Worst imaginable health state' (0). The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Baseline, 1 month, 3 months, and 6 months post-randomization
Perceived Stress Scale 4-Item survey (PSS-4)
Time Frame: Baseline, 1 month, 3 months, and 6 months post-randomization
This is a 4-item short version of the PSS. Scores can range from 0 (lowest stress) to 16 (highest level of stress)
Baseline, 1 month, 3 months, and 6 months post-randomization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire 10-Item symptoms scale (PHQ-10)
Time Frame: Baseline, 1 month, 3 months, and 6 months post-randomization
The PHQ-10 is an adapted version of the PHQ-15, a measure of physical symptoms. Scores can range from 0 (best) to 30 (worst).
Baseline, 1 month, 3 months, and 6 months post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

University of Colorado, Denver
University of California, Los Angeles
Oregon Health and Science University

Investigators

  • Principal Investigator: Christopher Cox, Professor of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

October 15, 2024

Primary Completion (Estimated)

November 15, 2027

Study Completion (Estimated)

April 15, 2028

Study Registration Dates

First Submitted

July 26, 2024

First Submitted That Met QC Criteria

July 31, 2024

First Posted (Actual)

August 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00115623

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Plan to share deidentified data via an approved and secure data sharing source on completion of the study and publication of results, as per NIH guidelines.

IPD Sharing Time Frame

Per NIH guidelines

IPD Sharing Access Criteria

To be determined

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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