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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Respiratory Insufficiency; Rehabilitation; Critical Care
• Intervention / Treatment: Behavioral: Behavioral Activation - Rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral Activation - Rehabilitation	Behavioral: Behavioral Activation - Rehabilitation; Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant's exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week's goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant's progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.
No Intervention: Usual Care Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility Measure Per Participant	Total number of intervention visits completed per patient as a proportion of the number of intervention visits each patient is intended to complete.	End of intervention (12 weeks)
Total Feasibility Measure	Total number of intervention visits completed by all study participants as a proportion of total intervention visits expected in the study	End of intervention (12 weeks)
Feasibility Measure/Assess Loss to Follow-up	Number of patients completing all study follow-up sessions as a proportion of the number of patients enrolled.	End of intervention (12 weeks)
Feasibility Measure	Average number of patients enrolled per month over 12 weeks	End of intervention (12 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (SCID-5)	A clinical interview to assess depressive symptoms. This is a qualitative assessment.	End of intervention (12 weeks)
Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale	An instrument used to assess anxiety symptoms. Scores range from 0 to 21. A HADS score ≥8 indicates clinically important symptoms on either subscale (more symptoms).	End of intervention (12 weeks)
Hospital Anxiety and Depression Scale (HADS) - Depression Subscale	An instrument used to assess depressive symptoms. Scores range from 0 to 21. A HADS score ≥8 indicates clinically important symptoms on either subscale (more symptoms).	End of intervention (12 weeks)
Personal Health Questionnaire - 8 Item Version (PHQ-8)	The PHQ-8 uses a 4-point Likert scale to assess depressive symptoms. The score range is 0 to 27. Scores 5-9 indicate "mild" symptoms, 10-14 "moderate", and ≥20 "severe" depressive symptoms. Higher score more symptoms.	End of intervention (12 weeks)
Activity Measure for Post-Acute Care Computer Adaptive Test (AMPAC-CAT) - Basic Mobility Score	The AMPAC-CAT, a measure of physical function, has 269 items across three domains (basic mobility, daily activity and applied cognitive). The computer adaptive test requires a mean of 22 items from the item bank. Scores are norm-based (min 0 and mx 100). Higher scores indicate better function.	End of intervention (12 weeks)
EQ-5D-5L - Utility Score	The EQ-5D-5L is an instrument developed by the EuroQol group to measure health status. The Eq-5D-5L has 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels, ranging from 1 (no problems) to 5 (extreme problems). The resulting health utility score ranges from -0.11 to 1.00. Higher scores indicate better health status.	End of intervention (12 weeks)
Healthcare Utilization - Readmissions	Patient interview to assess the following end of study (ie ~12 weeks) variable: number of patients with inpatient readmissions	End of intervention (12 weeks)
Healthcare Utilization - Ever Utilized Mental Health Care	Patient interview to assess the following end of study (ie ~12 weeks) variable: number of participants who ever utilized outpatient mental health	end of intervention (12 weeks)
Healthcare Utilization - Rehabilitation	Patient interview to assess the following end of study (ie ~12 weeks) variable: number of patients who ever utilized physical rehabilitation services	end of intervention (12 weeks)
Behavioral Activation for Depression SCALE (BAS)	This is a 25-item scale that measures changes in avoidance and activation over the course of Behavioral Activation treatment using a 7 point scale (0=not at all to 6=completely). The scale is grouped into 4 subscales (Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment). To calculate a total score, items on all subscales other than Activation are reverse-coded and then an unweighted sum is computed. Score range 0 to 150. Higher scores indicate greater activation.	End of intervention (12 weeks)
Connor-Davidson Resilience Scale (CD RISC)	This is a 25-item scale with each item rated on a 5-point scale (higher scores indicating greater resilience). The total score ranges from 0 to 100.	End of intervention (12 weeks)
Number of Phone Attempts Needed by the OT to Reach the Participant for Each Session	Measure of adherence	End of intervention (12 weeks)
Percentage of Sessions Fully Completed and Partially Completed	Measure of adherence for intervention group	End of intervention (12 weeks)
Montreal Cognitive Assessment (MoCA) - BLIND	Measure of cognitive impairment. Score range 0 - 22. Higher scores indicate better cognitive function.	End of intervention (12 weeks)
Impact of Events Scale - Revised (IES-R)	This is a measure the subjective response to a specific traumatic event (in this case - critical illness and associated ICU experience). The IES-R consists of 22 items, each rated on a 5-point scale; item scores are averaged to generate a mean total score (range: 0-4). Higher score indicates more stress symptoms.	End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Self Distraction Subscale	A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.	End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Active Coping Subscale	A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.	End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Denial Subscale	A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.	end of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Substance Use Subscale	A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.	End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Emotional Support Subscale	A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.	End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Instrumental Support Subscale	A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.	End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Behavioral Disengagement Subscale	A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.	End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Venting Subscale	A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.	End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Positive Reframing Subscale	A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.	End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Planning Subscale	A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.	End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Humor Subscale	A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.	End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Acceptance Subscale	A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.	End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Religion Subscale	A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.	End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Self-Blame Subscale	A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.	End of intervention (12 weeks)

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Ann M Parker, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2018
• Primary Completion (Actual): July 18, 2024
• Study Completion (Actual): July 18, 2024

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Estimated): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Respiratory Tract Diseases; Respiration Disorders; Behavior; Respiratory Insufficiency; Depression
• Other Study ID Numbers: IRB00143231; K23HL138206 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No