Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
Qualifiers
≥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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cognitive behavioral therapy based self-management for anxiety
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Johns Hopkins University
Lead sponsor
Francis Family Foundation
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov