RECRUITING

Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention

Quick Facts

Study Start:2024-05-31
Study Completion:2027-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06341972

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥18 years old
  2. * English speaking and not aphasic
  3. * ARF with mechanical ventilation via endotracheal tube \> 24 hours
  4. * Expected hospital stay of \>7 days at time of eligibility
  5. * Alert (ie, Richmond Agitation Sedation Scale sedation score = -1, 0, or 1)
  6. * Not delirious (ie, negative Confusion Assessment Method -ICU score)
  7. * Presence of anxiety symptoms (Visual Analog Scale-Anxiety score ≥50)\*\*
  1. * Pre-existing cognitive impairment (AD-8 score ≥2)
  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)
  3. * Declines or incapable of informed consent
  4. * Anticipated discharge to hospice, primary focus on palliative care, or \>90% probability of in-hospital death

Contacts and Locations

Study Contact

Megan Hosey, PhD
CONTACT
410-502-2429
mhosey@jhu.edu

Principal Investigator

Megan Hosey, PhD
PRINCIPAL_INVESTIGATOR
Johns Hopkins School of Medicine

Study Locations (Sites)

Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Megan Hosey, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-31
Study Completion Date2027-09-01

Study Record Updates

Study Start Date2024-05-31
Study Completion Date2027-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Respiratory Failure
  • Anxiety
  • Critical Illness