Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention

Recruiting now · Not applicable

Conditions studied: Respiratory Failure, Anxiety, Critical Illness

In brief

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.

Key facts

Study ID

NCT06341972

Run by

Johns Hopkins University

People needed

60

Starts

2024-05-31

Expected to finish

2028-09-01

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify 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)
• Not delirious (ie, negative Confusion Assessment Method -ICU score)
• Presence of anxiety symptoms (Visual Analog Scale-Anxiety score ≥50)**

You may not qualify 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 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

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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