Improving mental health for survivors of acute respiratory failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot randomized controlled trial aims to evaluate the feasibility and acceptability of a cognitive behavioral therapy-based self-management intervention for patients recovering from acute respiratory failure (ARF) in the ICU. Participants will be randomly assigned to either the intervention group, which receives the self-management program, or the usual care group. The study will assess the impact of the intervention on anxiety symptoms at hospital discharge and at a 3-month follow-up. The goal is to determine if this approach can effectively reduce anxiety and improve psychological outcomes for ICU patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Johns Hopkins Hospital
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Megan Hosey, PhD — Johns Hopkins School of Medicine
• Study coordinator: Megan Hosey, PhD
• Email: mhosey@jhu.edu
• Phone: 410-502-2429

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.