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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03431493
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : April 22, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE February 6, 2018
First Posted Date  ICMJE February 13, 2018
Last Update Posted Date April 22, 2019
Actual Study Start Date  ICMJE March 2, 2018
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2018)
  • Feasibility measure per participant [ Time Frame: End of intervention (12 weeks) ]
    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 [ Time Frame: End of intervention (12 weeks) ]
    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 [ 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) ]
    Number of patients enrolled per month
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2018)
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: End of intervention (12 weeks) ]
    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) [ Time Frame: End of intervention (12 weeks) ]
    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) [ Time Frame: End of intervention (12 weeks) ]
    A clinical interview to assess depressive symptoms. This is a qualitative assessment.
  • Activity Measure for Post-Acute Care Computer Adaptive Test (AMPAC-CAT) [ Time Frame: Baseline, end of intervention (12 weeks) ]
    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 [ Time Frame: End of intervention (12 weeks) ]
    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 [ Time Frame: End of intervention (12 weeks) ]
    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) [ Time Frame: Baseline, end of intervention (12 weeks) ]
    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) [ Time Frame: Baseline, end of intervention (12 weeks) ]
    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) [ Time Frame: Baseline, end of intervention (12 weeks) ]
    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 [ Time Frame: End of intervention (12 weeks) ]
    Measure of adherence
  • Proportion of sessions fully completed and partially completed [ Time Frame: End of intervention (12 weeks) ]
    Measure of adherence
  • Montreal Cognitive Assessment (MoCA) - BLIND [ Time Frame: End of intervention (12 weeks) ]
    Measure of cognitive impairment
  • Impact of Events Scale - Revised (IES-R) [ Time Frame: End of intervention (12 weeks) ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2018)
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: End of intervention (12 weeks) ]
    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) [ Time Frame: End of intervention (12 weeks) ]
    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) [ Time Frame: End of intervention (12 weeks) ]
    A clinical interview to assess depressive symptoms. This is a qualitative assessment.
  • Activity Measure for Post-Acute Care Computer Adaptive Test (AMPAC-CAT) [ Time Frame: End of intervention (12 weeks) ]
    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 [ Time Frame: End of intervention (12 weeks) ]
    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 [ Time Frame: End of intervention (12 weeks) ]
    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) [ Time Frame: Baseline, end of intervention (12 weeks) ]
    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) [ Time Frame: Baseline, end of intervention (12 weeks) ]
    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) [ Time Frame: Baseline, end of intervention (12 weeks) ]
    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 [ Time Frame: End of intervention (12 weeks) ]
    Measure of adherence
  • Proportion of sessions fully completed and partially completed [ Time Frame: End of intervention (12 weeks) ]
    Measure of adherence
  • Montreal Cognitive Assessment (MoCA) - BLIND [ Time Frame: End of intervention (12 weeks) ]
    Measure of cognitive impairment
  • Impact of Events Scale - Revised (IES-R) [ Time Frame: End of intervention (12 weeks) ]
    measure the subjective response to a specific traumatic event (in this case - critical illness and associated ICU experience)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Behavioral Activation-Rehabilitation to Improve Depressive Symptoms & Physical Function After Acute Respiratory Failure
Official Title  ICMJE A Pilot, Feasibility Randomized Controlled Trial of a Behavioral Activation And Rehabilitation Intervention To Improve Psychological And Physical Impairments In Acute Respiratory Failure Survivors
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Respiratory Insufficiency
  • Depression
  • Rehabilitation
  • Critical Care
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Behavioral Activation - Rehabilitation
    Behavioral Activation - Rehabilitation
    Intervention: Behavioral: Behavioral Activation - Rehabilitation
  • No Intervention: Usual Care Control
    Usual Care Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 6, 2018)
54
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Albahi M Malik 4109558706 amalik37@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03431493
Other Study ID Numbers  ICMJE IRB00143231
K23HL138206 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Ann M Parker, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP