NCT06341972 Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention
| NCT ID | NCT06341972 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-05-31 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-05-31 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. The main question\[s\] it aims to answer are: * Is this intervention feasible and acceptable in ARF patients? * Is this intervention in the ICU and hospital associated with reduced anxiety symptoms? Participants will participate in a cognitive behavioral therapy informed self-management intervention aimed to reduce anxiety symptoms. Researchers will compare the intervention group to patients who receive usual care to see if the intervention reduces symptoms at the the conclusion of the intervention and at 3 months follow-up.
Eligibility Criteria
Inclusion 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)\*\* Exclusion Criteria: * 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
Contact & Investigator
Megan Hosey, PhD
PRINCIPAL INVESTIGATOR
Johns Hopkins School of Medicine
Frequently Asked Questions
Who can join the NCT06341972 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06341972 currently recruiting?
Yes, NCT06341972 is actively recruiting participants. Contact the research team at mhosey@jhu.edu for enrollment information.
Where is the NCT06341972 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06341972 clinical trial?
NCT06341972 is sponsored by Johns Hopkins University. The principal investigator is Megan Hosey, PhD at Johns Hopkins School of Medicine. The trial plans to enroll 60 participants.