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New treatment option for Depression
Official title Adaptive Coping Skills Training to Improve Psychological Distress Among Cardiorespiratory Failure Survivors
ClinicalTrials.gov ID: NCT06538246
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- present in the hospital
- Adult (age ≥18)
- Managed in an ICU or stepdown unit for ≥24 hours during the time inclusion criterion #3 is met
- Serious acute cardiorespiratory condition, defined as ≥1 of the following:
- mechanical ventilation via endotracheal tube for ≥4 hours
You likely can't join if
- Exclusion criteria present in the hospital
- Active alcohol or drug abuse (e.g., admission for alcohol withdrawal, drug-related complication, positive toxicology screening at admission...
- 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
See the full eligibility criteria
- present in the hospital
- Adult (age ≥18)
- Managed in an ICU or stepdown unit for ≥24 hours during the time inclusion criterion #3 is met
- 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
- 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...
- Evidence of poorly managed severe mental illness
- No endorsement of suicidality at time of admission or informed consent
- Functional fluency in English or Spanish (i.e., sufficient knowledge of English or Spanish to complete study tasks like watch videos, complete surveys) present after hospital discharge (i.e., at the time of arrival home...
- Exclusion criteria present in the hospital
- 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...
- 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 Exclusion criteria present after hospital discharge (i.e., at T1 Data Collection conducted at the time of arrival home from the hospital)
- 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)
- Readmission to hospital before randomization completed
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.