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New anxiety program for ICU survivors shows promise in early trial

NCT ID NCT06341972

Symptom relief Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests a self-management program based on cognitive behavioral therapy to help people who survived acute respiratory failure and now struggle with anxiety. Sixty ICU survivors will either receive the program or usual care. The goal is to see if the program is practical and reduces anxiety symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cognitive behavioral therapy based self-management program
What this could lead to
If it works, this could provide a practical way to reduce anxiety and improve mental health for people who survive severe breathing problems in the ICU.
What could go wrong
This is a very small pilot study with only 60 people, so results may not apply to everyone. It is testing feasibility, not yet proven to work.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

acute respiratory failure anxiety anxiety disorder Critical Illness respiratory failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anxiety Critical illness Respiratory failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.