Improving mental health for survivors of acute respiratory failure
Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention
This study is testing a new self-management program based on therapy to see if it can help reduce anxiety in patients recovering from acute respiratory failure in the ICU.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06341972 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are English-speaking, experiencing acute respiratory failure requiring mechanical ventilation, and showing signs of anxiety.
Not a fit: Patients with pre-existing cognitive impairments or major psychiatric illnesses may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce anxiety symptoms in ARF survivors, improving their overall mental health and quality of life.
How similar studies have performed: While there is limited evidence on similar interventions specifically for ARF patients, cognitive behavioral therapy has been established as an effective treatment for anxiety in other populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.