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

Johns Hopkins University

Status

Completed

Conditions

Rehabilitation

Critical Care

Respiratory Insufficiency

Depression

Treatments

Behavioral: Behavioral Activation - Rehabilitation

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03431493

K23HL138206 (U.S. NIH Grant/Contract)

IRB00143231

Details and patient eligibility

About

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.

Full description

A growing number of Acute Respiratory Failure (ARF) survivors are burdened by depressive symptoms and physical impairments that last for years after intensive care unit discharge. Notably, depressive symptoms are independently associated with subsequent development of new impairments in physical functioning. There is a lack of treatment options to address these impairments in ARF survivors, with past research suggesting combining treatment for mental and physical health might be more successful.

Therefore, this study is designed to evaluate:

The feasibility (primary outcome) of participant recruitment and retention in a pilot randomized controlled trial (RCT) of an intervention combining Behavioral Activation (an evidence-based psychological treatment for depression) and physical rehabilitation delivered via telephone and 2 home visits over 12-weeks versus a "usual care" control group.
The efficacy (secondary outcome) of this Behavioral Activation-Rehabilitation intervention to reduce depressive symptoms and improve physical functioning.
Modifiable psychosocial risk factors for depressive symptoms in ARF survivors and the association between the intervention and these modifiable factors.

Enrollment

52 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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