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

Primary Purpose

Respiratory Insufficiency, Depression, Rehabilitation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation - Rehabilitation
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Insufficiency

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Johns Hopkins UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Behavioral Activation - Rehabilitation

Usual Care Control

Arm Description

Behavioral Activation - Rehabilitation

Usual Care Control

Outcomes

Primary Outcome Measures

Feasibility measure per participant
Total number of intervention phone calls completed per patient as a proportion of the number of intervention phone calls each patient is intended to complete.
Total feasibility measure
Total number of intervention phone calls completed by all study participants as a proportion of total intervention phone calls expected in the study
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.
Feasibility measure
Number of patients enrolled per month

Secondary Outcome Measures

Hospital Anxiety and Depression Scale (HADS)
An instrument used to assess depressive and anxiety symptoms. Scores for each subscale range from 0 to 21. A HADS score ≥8 indicates clinically important symptoms on either subscale.
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.
Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (SCID-5)
A clinical interview to assess depressive symptoms. This is a qualitative assessment.
Activity Measure for Post-Acute Care Computer Adaptive Test (AMPAC-CAT)
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.
EQ-5D-5L
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. The EQ-5D-5L also records the respondent's self-rated health on a visual analog scale (0 to 100).
Healthcare Utilization
Patient interview to assess the following post-discharge variables: inpatient readmissions (hospitals, skilled nursing facilities, acute and sub-acute rehabilitation facilities) and outpatient mental health and physical rehabilitation services
Brief Coping with Problems Experienced (Brief COPE)
A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Scores are provided for the 14 subscales, each of which corresponds to a specific coping strategy (minimum score=2 to maximum score=8).
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.
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.
Number of phone attempts needed by the OT to reach the participant for each session
Measure of adherence
Proportion of sessions fully completed and partially completed
Measure of adherence
Montreal Cognitive Assessment (MoCA) - BLIND
Measure of cognitive impairment
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).

Full Information

First Posted
February 6, 2018
Last Updated
May 25, 2023
Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03431493
Brief Title
Behavioral Activation-Rehabilitation to Improve Depressive Symptoms & Physical Function After Acute Respiratory Failure
Acronym
BEHAB
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2018 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency, Depression, Rehabilitation, Critical Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Activation - Rehabilitation
Arm Type
Experimental
Arm Description
Behavioral Activation - Rehabilitation
Arm Title
Usual Care Control
Arm Type
No Intervention
Arm Description
Usual Care Control
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation - Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility measure per participant
Description
Total number of intervention phone calls completed per patient as a proportion of the number of intervention phone calls each patient is intended to complete.
Time Frame
End of intervention (12 weeks)
Title
Total feasibility measure
Description
Total number of intervention phone calls completed by all study participants as a proportion of total intervention phone calls expected in the study
Time Frame
End of intervention (12 weeks)
Title
Feasibility measure/Assess loss to follow-up
Description
Number of patients completing all study follow-up sessions as a proportion of the number of patients enrolled.
Time Frame
End of intervention (12 weeks)
Title
Feasibility measure
Description
Number of patients enrolled per month
Time Frame
End of intervention (12 weeks)
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Description
An instrument used to assess depressive and anxiety symptoms. Scores for each subscale range from 0 to 21. A HADS score ≥8 indicates clinically important symptoms on either subscale.
Time Frame
End of intervention (12 weeks)
Title
Personal Health Questionnaire - 8 item version (PHQ-8)
Description
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.
Time Frame
End of intervention (12 weeks)
Title
Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (SCID-5)
Description
A clinical interview to assess depressive symptoms. This is a qualitative assessment.
Time Frame
End of intervention (12 weeks)
Title
Activity Measure for Post-Acute Care Computer Adaptive Test (AMPAC-CAT)
Description
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.
Time Frame
Baseline, end of intervention (12 weeks)
Title
EQ-5D-5L
Description
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. The EQ-5D-5L also records the respondent's self-rated health on a visual analog scale (0 to 100).
Time Frame
End of intervention (12 weeks)
Title
Healthcare Utilization
Description
Patient interview to assess the following post-discharge variables: inpatient readmissions (hospitals, skilled nursing facilities, acute and sub-acute rehabilitation facilities) and outpatient mental health and physical rehabilitation services
Time Frame
End of intervention (12 weeks)
Title
Brief Coping with Problems Experienced (Brief COPE)
Description
A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Scores are provided for the 14 subscales, each of which corresponds to a specific coping strategy (minimum score=2 to maximum score=8).
Time Frame
Baseline, end of intervention (12 weeks)
Title
Behavioral Activation for Depression SCALE (BAS)
Description
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.
Time Frame
Baseline, end of intervention (12 weeks)
Title
Connor-Davidson Resilience Scale (CD RISC)
Description
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.
Time Frame
Baseline, end of intervention (12 weeks)
Title
Number of phone attempts needed by the OT to reach the participant for each session
Description
Measure of adherence
Time Frame
End of intervention (12 weeks)
Title
Proportion of sessions fully completed and partially completed
Description
Measure of adherence
Time Frame
End of intervention (12 weeks)
Title
Montreal Cognitive Assessment (MoCA) - BLIND
Description
Measure of cognitive impairment
Time Frame
End of intervention (12 weeks)
Title
Impact of Events Scale - Revised (IES-R)
Description
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).
Time Frame
End of intervention (12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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): 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ann M Parker
Phone
4109558706
Email
ann.parker@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann M Parker, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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