Recruiting

Self-Management Intervention

Sponsor:

Johns Hopkins University

Code:

NCT06341972

Conditions

Respiratory Failure

Anxiety

Critical Illness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Cognitive behavioral therapy based self-management for anxiety

Study Details

Brief summary:

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.

Conditions

Respiratory Failure

Anxiety

Critical Illness

Study ID

NCT06341972

Start date

May 31, 2024

Status verified date

Jun, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Self-management intervention

Cognitive behavioral therapy based self-management intervention for anxiety

no intervention: Usual Care

Usual hospital-based care

Interventions

Cognitive behavioral therapy based self-management for anxiety

Evidenced based approach for educating patients about how to manage anxiety after respiratory failure.

Primary outcome measure

  • Treatment Satisfaction Questionnaire [ Time Frame: 5 weeks post-enrollment ]
  • average accrual rate of 2 patients/month across all patients [ Time Frame: 3 years ]
  • treatment feasibility as assessed by sessions completed [ Time Frame: 5 weeks post enrollment ]
  • treatment feasibility as assessed by drop out rate [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Megan Hosey, PhD

410-502-2429mhosey@jhu.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Megan Hosey

410-502-2429hmegan1@jhmi.edu

hmegan1@jhmi.edu

Principal Investigator:

Megan Hosey, PhD

More Information

Sponsor

Johns Hopkins University

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-06-22.