No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Johns Hopkins University · Other
Who this trial is looking for
This trial is looking for adults who have survived respiratory failure and are experiencing anxiety. Participants will take part in a program to help manage anxiety symptoms and will be compared to those receiving standard care.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older
I speak English and can communicate
I have had respiratory failure and needed a breathing tube for over 24 hours
I am expected to stay in the hospital for more than 7 days
I am alert and responsive
I am not confused
I have anxiety symptoms
You may not be able to join if
I have a history of major psychiatric illness
I have had a severe cognitive impairment
I cannot give informed consent
I am expected to be discharged to hospice care
I have a high chance of dying in the hospital
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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City
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Status
Eligibility 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, ne…
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
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