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New therapy aims to help ICU survivors recover mind and body

NCT ID NCT03431493

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

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This pilot study tested whether a therapy that combines behavioral activation for depression with physical rehabilitation is feasible for survivors of acute respiratory failure. Fifty-two adults who had been on life support in the ICU received home visits and phone calls from therapists over several weeks. The goal was to see if this approach could be delivered successfully and might improve both mental and physical recovery.

What this could mean

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

Active substance
Behavioral activation and rehabilitation therapy delivered via telephone and home visits
What this could lead to
If successful, this approach could provide a practical way to help ICU survivors recover both mentally and physically after a serious illness.
What could go wrong
This is a small pilot study focused on feasibility, not effectiveness. The intervention may not show clear benefits in larger trials.

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

52 people

The number who actually took part.

Started

Mar 2018

Finished

Jul 2024

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 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 * Living at home before the current admission (not in a facility) * Acute respiratory failure managed in the ICU \> 24hrs (≥1 of the following): 1. Mechanical ventilation via an endotracheal tube or tracheostomy \> 12hrs (and not ventilator-dependent before admission) OR 2. Non-invasive ventilation (CPAP, BiPAP) \> 4 hours in a 24 hour period provided for acute respiratory failure (not for Obstructive Sleep Apnoea (OSA) or other stable use) OR 3. High flow nasal cannula with Fraction of Inspired Oxygen (FiO2) ≥ 0.5 for ≥4 hours in a 24hr period * At least mild depressive symptoms (score ≥2 on PHQ-2 scale) Exclusion Criteria: * Pre-existing cognitive impairment (based on review of medical records, or proxy- administered Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) score \>3.3) * Declines informed consent or not capable of providing informed consent * Non-English speaking * Homelessness or living \>50 miles away from study site * Bedbound prior to the current admission * Expected survival \< 6 months according to ICU attending * ICU Length Of Stay (LOS) \> 30 days * Not discharged home from the hospital * Complex medical care expected soon after discharge (e.g. multiple planned surgeries, transplantation evaluation, extensive travel needs for hemodialysis, chemotherapy or radiation therapy, etc) * Active substance abuse or psychosis * Lack of access to telephone or inability to use telephone independently * Pregnancy * Suicidality * Incarcerated

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Conditions

The condition(s) this trial relates to.

acute respiratory failure Depression depressive disorder respiratory failure

As listed by the trial registrant

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

Critical care Depression Rehabilitation Respiratory insufficiency

Contacts and locations

Locations

  • Johns Hopkins University

    Baltimore, Maryland, 21205, United States

More trials for these conditions

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