NCT06341972 · Johns Hopkins University
Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention
(SMARA)
What this 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Baltimore, Maryland
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations