Clinical trial NCT03431493: Behavioral Activation-Rehabilitation to Improve Depressive Symptoms & Physical Function After Acute Respiratory Failure
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Insufficiency
Depression
Rehabilitation
Critical Care
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-02-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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:

1. 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.
2. The efficacy (secondary outcome) of this Behavioral Activation-Rehabilitation intervention to reduce depressive symptoms and improve physical functioning.
3. Modifiable psychosocial risk factors for depressive symptoms in ARF survivors and the association between the intervention and these modifiable factors.

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

Primary outcomes:
measure: Feasibility measure per participant
timeFrame: End of intervention (12 weeks)
measure: Total feasibility measure
timeFrame: End of intervention (12 weeks)
measure: Feasibility measure/Assess loss to follow-up
timeFrame: End of intervention (12 weeks)
measure: Feasibility measure
timeFrame: End of intervention (12 weeks)
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: End of intervention (12 weeks)
measure: Personal Health Questionnaire - 8 item version (PHQ-8)
timeFrame: End of intervention (12 weeks)
measure: Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (SCID-5)
timeFrame: End of intervention (12 weeks)
measure: Activity Measure for Post-Acute Care Computer Adaptive Test (AMPAC-CAT)
timeFrame: Baseline, end of intervention (12 weeks)
measure: EQ-5D-5L
timeFrame: End of intervention (12 weeks)
measure: Healthcare Utilization
timeFrame: End of intervention (12 weeks)
measure: Brief Coping with Problems Experienced (Brief COPE)
timeFrame: Baseline, end of intervention (12 weeks)
measure: Behavioral Activation for Depression SCALE (BAS)
timeFrame: Baseline, end of intervention (12 weeks)
measure: Connor-Davidson Resilience Scale (CD RISC)
timeFrame: Baseline, end of intervention (12 weeks)
measure: Number of phone attempts needed by the OT to reach the participant for each session
timeFrame: End of intervention (12 weeks)
measure: Proportion of sessions fully completed and partially completed
timeFrame: End of intervention (12 weeks)
measure: Montreal Cognitive Assessment (MoCA) - BLIND
timeFrame: End of intervention (12 weeks)
measure: Impact of Events Scale - Revised (IES-R)
timeFrame: End of intervention (12 weeks)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Ann M Parker, MD
role: PRINCIPAL_INVESTIGATOR
References: