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

This study is looking at a behavioral therapy called cognitive behavioral therapy based self-management for anxiety. This therapy aims to help people who have had acute respiratory failure (ARF), which is when your lungs can't get enough oxygen into your blood, and needed a breathing machine for more than 24 hours. Many people who survive a serious illness like this can have long-lasting anxiety. This study wants to see if this therapy, which teaches you how to manage anxiety, can help reduce anxiety symptoms while you are still in the hospital. We are also checking if the therapy is practical and acceptable for patients. We plan to include 60 participants. The study status is currently unclear.

Study design
This is an interventional study that plans to enroll 60 participants. It is a pilot randomized controlled trial, meaning participants will be assigned by chance to either receive the intervention or usual care.
What's involved
Participants will take part in cognitive behavioral therapy informed self-management sessions. The primary outcomes are measured at 5 weeks post-enrollment.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a 3-month phone-based follow-up after hospital discharge.

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NCT06341972

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

Recruiting
NAAges 18+InterventionalTreatment
Johns Hopkins University
~60 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:Cognitive behavioral therapy based self-management for anxiety

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment Satisfaction Questionnaire
Measured over 5 weeks post-enrollment
+3 more outcomes measured
Respiratory Failure
Anxiety
Critical Illness
1 sites across 1 states
Maryland1
  • Megan Hosey, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins School of Medicine

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Eligibility criteria

Inclusion

≥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

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
  • Treatment Satisfaction Questionnaire5 weeks post-enrollment

    Treatment Satisfaction Questionnaire (TSQ) ranges from 0-21, with higher scores representing greater satisfaction. Items (e.g., "useful", "liked it," "perceived symptom improvement") are scored based on a Likert scale, ranging from 0= "not at all" to 7= "very much so." Higher scores indicate higher satisfaction

  • average accrual rate of 2 patients/month across all patients3 years

    treatment feasibility objective

  • treatment feasibility as assessed by sessions completed5 weeks post enrollment

    treatment feasibility as assessed by \>70% of intervention sessions completed

  • treatment feasibility as assessed by drop out rate3 years

    treatment feasibility as assessed by \<15% drop-out across intervention arm