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Search / Trial NCT03431493

Behavioral Activation-Rehabilitation to Improve Depressive Symptoms & Physical Function After Acute Respiratory Failure

Launched by JOHNS HOPKINS UNIVERSITY · Feb 6, 2018

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a combined approach to help patients who have just survived a serious respiratory failure, often requiring life support. Many of these patients struggle with depression and have difficulties moving around after their hospital stay, which can affect their overall quality of life. The trial is testing whether a therapy that includes both mental health support and physical rehabilitation, delivered through phone calls and home visits, can effectively help these patients recover better and faster.

To be eligible for this trial, participants need to be at least 18 years old, have lived at home before their hospital stay, and have experienced acute respiratory failure for more than 24 hours. They should also have some signs of depression. If you join the study, you can expect to receive support tailored to improve both your mood and physical well-being. It's important to note that some individuals may not qualify, such as those with severe cognitive issues or those who are unable to provide consent. This trial aims to find better ways to support patients during their recovery journey and improve their overall health outcomes.

Gender

ALL

Eligibility criteria

  • 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

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

Baltimore, Maryland, United States

Patients applied

0 patients applied

Trial Officials

Ann M Parker, MD

Principal Investigator

Johns Hopkins University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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