COMPLETED

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

Conditions

Respiratory Insufficiency Depression Rehabilitation Critical Care

Quick Navigation

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

More and more people are surviving after receiving life support for respiratory failure in the intensive care unit, but these patients often experience problems with depression and physical functioning that lead to reduced quality of life. There is a lack of treatment for these patients, with past research suggesting that treatment may be more successful if mental and physical health are addressed at the same time. This research evaluates whether a therapy delivered via telephone and home visits, combining treatment for depression and physical rehabilitation, is feasible and might help patients recover.

Official Title

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

Quick Facts

Study Start:2018-03-02

Study Completion:2024-07-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT03431493

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 to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Principal Investigator

Ann M Parker, MD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins University

Baltimore, Maryland, 21205

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Ann M Parker, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

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 Date2018-03-02

Study Completion Date2024-07-18

Study Record Updates

Study Start Date2018-03-02

Study Completion Date2024-07-18

Terms related to this study

Additional Relevant MeSH Terms

Respiratory Insufficiency
Depression
Rehabilitation
Critical Care