Recruiting

Coping Skills Training

Sponsor:

Duke University

Code:

NCT06538246

Conditions

Depression

Anxiety

Post-traumatic Stress Disorder

Stress

Worries; Pain or Disability

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blueprint

Education program

Study Details

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

Study ID

NCT06538246

Start date

Oct 15, 2024

Status verified date

Jul, 2026

Completion date

Apr 15, 2028

Anticipated

Primary completion date

Nov 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Blueprint

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

Education program

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Principal Investigator:

Christopher Cox, MD

More Information

Sponsor

Duke University

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-07-23.