Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06341972

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

Led by Johns Hopkins University · Updated on 2025-06-05

60

Participants Needed

1

Research Sites

169 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

F

Francis Family Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • ≥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)**
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

Actively Recruiting

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Research Team

M

Megan Hosey, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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