Improving depression and physical function after respiratory failure

A Pilot, Feasibility Randomized Controlled Trial of a Behavioral Activation And Rehabilitation Intervention To Improve Psychological And Physical Impairments In Acute Respiratory Failure Survivors

This study is testing a new therapy that combines phone and home support to help people recovering from respiratory failure improve their mood and physical abilities.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Johns Hopkins University (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT03431493 on ClinicalTrials.gov

What this trial studies

This study evaluates a combined therapy approach for patients recovering from acute respiratory failure, focusing on both depressive symptoms and physical rehabilitation. The intervention includes Behavioral Activation, a psychological treatment for depression, delivered through telephone sessions and home visits over a 12-week period. Participants will be compared to a control group receiving usual care to assess the feasibility of recruitment and retention, as well as the efficacy of the intervention in improving mental and physical health outcomes. The study also aims to identify modifiable psychosocial risk factors associated with depression in these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced acute respiratory failure and exhibit at least mild depressive symptoms.

Not a fit: Patients with pre-existing cognitive impairments or those who are non-English speaking may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance the quality of life for patients recovering from respiratory failure by addressing both their mental and physical health needs.

How similar studies have performed: Previous studies have suggested that integrated treatment approaches for mental and physical health can be more effective, indicating potential success for this novel intervention.

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

Where this trial is running

Baltimore, Maryland

• Johns Hopkins University — Baltimore, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Ann M Parker, MD — Johns Hopkins University
• Study coordinator: Ann M Parker

Conditions: Respiratory Insufficiency, Depression, Rehabilitation, Critical Care