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New treatment option for Respiratory Failure
Official title Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention
ClinicalTrials.gov ID: NCT06341972
What this study is testing
- What it's testing
- A growing number of patients are surviving a stay in the intensive care unit (ICU) but may experience long-lasting psychological problems, but research evaluating such treatment for ICU patients is scant. The goal of this pilot randomized controlled trial is to evaluate the feasibility, acceptability, and potential benefit of an evidence-based psychological intervention for anxiety and associated outcomes for ICU patients.
- Which group you join is 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. Healthy volunteers may be eligible.
You may be able to join if
- ≥18 years old
- English speaking and not aphasic
- ARF with mechanical ventilation via endotracheal tube \> 24 hours
- Expected hospital stay of \>7 days at time of eligibility
- Alert (ie, Richmond Agitation Sedation Scale sedation score = -1, 0, or 1)
You likely can't join if
- Pre-existing cognitive impairment (AD-8 score ≥2)
- History of major psychiatric illness (i.e., psychotic disorder, bi-polar disorder, suicide attempt in past 24 months, pervasive developmental...
- Declines or incapable of informed consent
- Anticipated discharge to hospice, primary focus on palliative care, or \>90% probability of in-hospital death
See the full eligibility criteria
- ≥18 years old
- English speaking and not aphasic
- ARF with mechanical ventilation via endotracheal tube \> 24 hours
- Expected hospital stay of \>7 days at time of eligibility
- Alert (ie, Richmond Agitation Sedation Scale sedation score = -1, 0, or 1)
- Not delirious (ie, negative Confusion Assessment Method -ICU score)
- Presence of anxiety symptoms (Visual Analog Scale-Anxiety score ≥50)\ \
- Pre-existing cognitive impairment (AD-8 score ≥2)
- History of major psychiatric illness (i.e., psychotic disorder, bi-polar disorder, suicide attempt in past 24 months, pervasive developmental disorder, active substance use disorder)
- Declines or incapable of informed consent
- Anticipated discharge to hospice, primary focus on palliative care, or \>90% probability of in-hospital death
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, 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.