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

Johns Hopkins University · with Francis Family Foundation, National Heart, Lung, and Blood Institute (NHLBI) · NCT06341972

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
60
US sites recruiting
1
Study start
May 31, 2024
Record last updated
June 22, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Cognitive behavioral therapy based self-management for anxiety

Conditions: Respiratory Failure; Anxiety; Critical Illness

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Johns Hopkins Hospital

    Baltimore, MD 21287

    Site contact: Megan Hosey · 410-502-2429 · hmegan1@jhmi.edu

Study contacts (from the official record)

  • Megan Hosey, PhD · 410-502-2429 · mhosey@jhu.edu
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Improving Psychological Outcomes for Acute Respiratory Failure… (NCT06341972) | Bored Studies