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Search / Trial NCT06341972

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

Launched by JOHNS HOPKINS UNIVERSITY · Apr 1, 2024

Trial Information

Current as of July 21, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help patients who have survived severe breathing problems and spent time in the intensive care unit (ICU). Many of these patients may experience anxiety and other psychological issues after their stay, and the goal of this study is to see if a specific self-management program can help reduce those anxiety symptoms. The program is based on cognitive behavioral therapy, which is a type of talk therapy that helps people manage their thoughts and feelings. The researchers will compare patients who take part in this program with those who receive standard care to see if it makes a difference in their anxiety levels.

To be eligible for this trial, participants need to be adults aged 18 or older, have experienced acute respiratory failure with mechanical ventilation for more than 24 hours, and show signs of anxiety. They should also be alert and not suffering from confusion. If someone is interested in joining, they can expect to participate in the self-management program during their hospital stay, and researchers will check in with them to see how they’re feeling at the end of the program and three months later. This trial is currently recruiting participants, and it’s important to know that individuals with certain pre-existing mental health issues or severe cognitive impairments may not qualify.

Gender

ALL

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, 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

About Johns Hopkins University

Johns Hopkins University, a prestigious research institution located in Baltimore, Maryland, is renowned for its commitment to advancing medical science and public health through innovative clinical trials. With a rich history of groundbreaking research and a multidisciplinary approach, the university's clinical trial initiatives focus on translating scientific discoveries into effective treatments and interventions. Leveraging state-of-the-art facilities and a collaborative network of experts, Johns Hopkins University conducts rigorous clinical studies that aim to improve patient outcomes and address critical health challenges. Its dedication to ethical standards and participant safety underscores its role as a leader in clinical research.

Locations

Baltimore, Maryland, United States

Patients applied

0 patients applied

Trial Officials

Megan Hosey, PhD

Principal Investigator

Johns Hopkins School of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported