A Pilot, Feasibility Randomized Controlled Trial of a Behavioral Activation And Rehabilitation Intervention To Improve Psychological And Physical Impairments In Acute Respiratory Failure Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 52
- Locations
- 2
- Primary Endpoint
- Feasibility Measure Per Participant
Study Overview
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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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):
- •Mechanical ventilation via an endotracheal tube or tracheostomy > 12hrs (and not ventilator-dependent before admission) OR
- •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
- •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
Outcomes
Primary Outcomes
Feasibility Measure Per Participant
Time Frame: End of intervention (12 weeks)
Total number of intervention visits completed per patient as a proportion of the number of intervention visits each patient is intended to complete.
Total Feasibility Measure
Time Frame: End of intervention (12 weeks)
Total number of intervention visits completed by all study participants as a proportion of total intervention visits expected in the study
Feasibility Measure/Assess Loss to Follow-up
Time Frame: End of intervention (12 weeks)
Number of patients completing all study follow-up sessions as a proportion of the number of patients enrolled.
Feasibility Measure
Time Frame: End of intervention (12 weeks)
Average number of patients enrolled per month over 12 weeks
Secondary Outcomes
- Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (SCID-5)(End of intervention (12 weeks))
- Montreal Cognitive Assessment (MoCA) - BLIND(End of intervention (12 weeks))
- Impact of Events Scale - Revised (IES-R)(End of intervention (12 weeks))
- Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale(End of intervention (12 weeks))
- Hospital Anxiety and Depression Scale (HADS) - Depression Subscale(End of intervention (12 weeks))
- Personal Health Questionnaire - 8 Item Version (PHQ-8)(End of intervention (12 weeks))
- Activity Measure for Post-Acute Care Computer Adaptive Test (AMPAC-CAT) - Basic Mobility Score(End of intervention (12 weeks))
- EQ-5D-5L - Utility Score(End of intervention (12 weeks))
- Healthcare Utilization - Readmissions(End of intervention (12 weeks))
- Healthcare Utilization - Ever Utilized Mental Health Care(end of intervention (12 weeks))
- Healthcare Utilization - Rehabilitation(end of intervention (12 weeks))
- Behavioral Activation for Depression SCALE (BAS)(End of intervention (12 weeks))
- Connor-Davidson Resilience Scale (CD RISC)(End of intervention (12 weeks))
- Number of Phone Attempts Needed by the OT to Reach the Participant for Each Session(End of intervention (12 weeks))
- Percentage of Sessions Fully Completed and Partially Completed(End of intervention (12 weeks))
- Montreal Cognitive Assessment (MoCA) - BLIND(End of intervention (12 weeks))
- Impact of Events Scale - Revised (IES-R)(End of intervention (12 weeks))
- Brief Coping With Problems Experienced (Brief COPE) - Self Distraction Subscale(End of intervention (12 weeks))
- Brief Coping With Problems Experienced (Brief COPE) - Active Coping Subscale(End of intervention (12 weeks))
- Brief Coping With Problems Experienced (Brief COPE) - Denial Subscale(end of intervention (12 weeks))
- Brief Coping With Problems Experienced (Brief COPE) - Substance Use Subscale(End of intervention (12 weeks))
- Brief Coping With Problems Experienced (Brief COPE) - Emotional Support Subscale(End of intervention (12 weeks))
- Brief Coping With Problems Experienced (Brief COPE) - Instrumental Support Subscale(End of intervention (12 weeks))
- Brief Coping With Problems Experienced (Brief COPE) - Behavioral Disengagement Subscale(End of intervention (12 weeks))
- Brief Coping With Problems Experienced (Brief COPE) - Venting Subscale(End of intervention (12 weeks))
- Brief Coping With Problems Experienced (Brief COPE) - Positive Reframing Subscale(End of intervention (12 weeks))
- Brief Coping With Problems Experienced (Brief COPE) - Planning Subscale(End of intervention (12 weeks))
- Brief Coping With Problems Experienced (Brief COPE) - Humor Subscale(End of intervention (12 weeks))
- Brief Coping With Problems Experienced (Brief COPE) - Acceptance Subscale(End of intervention (12 weeks))
- Brief Coping With Problems Experienced (Brief COPE) - Religion Subscale(End of intervention (12 weeks))
- Brief Coping With Problems Experienced (Brief COPE) - Self-Blame Subscale(End of intervention (12 weeks))
- Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (SCID-5)(End of intervention (12 weeks))