Adaptive Coping Skills Training to Improve Psychological Distress Among Cardiorespiratory Failure Survivors
Recruiting
N/AInterventional Study
DepressionAnxietyPost-traumatic Stress DisorderStressWorries; Pain or DisabilityBreath Shortness
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
400 (estimated)
Sponsor
Duke University · Other
Who this trial is looking for
This trial is looking for adults who have recently been in an ICU for serious breathing or heart problems. Participants will use a mobile app to help manage symptoms like depression and anxiety over six months.
Are You a Good Fit for This Trial?
You may be able to join if
I am an adult (age 18 or older).
I spent at least 24 hours in an ICU or stepdown unit.
I have a serious breathing or heart condition.
My cognitive status is intact.
I have not had severe mental illness treatment in the last 6 months.
I can communicate in English or Spanish.
I have psychological distress symptoms.
You may not be able to join if
I have active alcohol or drug abuse.
I have complex medical needs after hospital discharge.
I have other complex needs that could interfere with the study.
I will be discharged to a nursing home or similar facility.
I have persistently impaired cognition due to my illness.
I am currently imprisoned or in home detention.
I do not have a reliable smartphone with internet access.
I am enrolled in another conflicting study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 ex…
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.
Trial Locations
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Eligibility Criteria
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 endotrach…
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
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