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Completed

NCT Number: NCT03431493

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

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.

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Key information

Conditions

Respiratory Insufficiency Behavior Behavioral Symptoms Critical Care Depression Rehabilitation Respiration Disorders Respiratory Tract Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral Activation - Rehabilitation

Behavioral

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 outcomes

  1. 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.

  2. 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

  3. 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.

  4. Feasibility Measure

    Time frame: End of intervention (12 weeks)

    Average number of patients enrolled per month over 12 weeks

Secondary outcomes

  1. Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale

    Time frame: End of intervention (12 weeks)

    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).

  2. Hospital Anxiety and Depression Scale (HADS) - Depression Subscale

    Time frame: End of intervention (12 weeks)

    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).

  3. 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. Higher score more symptoms.

  4. Activity Measure for Post-Acute Care Computer Adaptive Test (AMPAC-CAT) - Basic Mobility Score

    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 (min 0 and mx 100). Higher scores indicate better function.

  5. EQ-5D-5L - Utility Score

    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. Higher scores indicate better health status.

  6. Healthcare Utilization - Readmissions

    Time frame: End of intervention (12 weeks)

    Patient interview to assess the following end of study (ie ~12 weeks) variable: number of patients with inpatient readmissions

  7. Healthcare Utilization - Ever Utilized Mental Health Care

    Time frame: end of intervention (12 weeks)

    Patient interview to assess the following end of study (ie ~12 weeks) variable: number of participants who ever utilized outpatient mental health

  8. Healthcare Utilization - Rehabilitation

    Time frame: end of intervention (12 weeks)

    Patient interview to assess the following end of study (ie ~12 weeks) variable: number of patients who ever utilized physical rehabilitation services

  9. Behavioral Activation for Depression SCALE (BAS)

    Time frame: 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. Score range 0 to 150. Higher scores indicate greater activation.

  10. Connor-Davidson Resilience Scale (CD RISC)

    Time frame: 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.

  11. 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

  12. Percentage of Sessions Fully Completed and Partially Completed

    Time frame: End of intervention (12 weeks)

    Measure of adherence for intervention group

  13. Montreal Cognitive Assessment (MoCA) - BLIND

    Time frame: End of intervention (12 weeks)

    Measure of cognitive impairment. Score range 0 - 22. Higher scores indicate better cognitive function.

  14. 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). Higher score indicates more stress symptoms.

  15. Brief Coping With Problems Experienced (Brief COPE) - Self Distraction Subscale

    Time frame: End of intervention (12 weeks)

    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.

  16. Brief Coping With Problems Experienced (Brief COPE) - Active Coping Subscale

    Time frame: End of intervention (12 weeks)

    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.

  17. Brief Coping With Problems Experienced (Brief COPE) - Denial Subscale

    Time frame: end of intervention (12 weeks)

    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.

  18. Brief Coping With Problems Experienced (Brief COPE) - Substance Use Subscale

    Time frame: End of intervention (12 weeks)

    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.

  19. Brief Coping With Problems Experienced (Brief COPE) - Emotional Support Subscale

    Time frame: End of intervention (12 weeks)

    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.

  20. Brief Coping With Problems Experienced (Brief COPE) - Instrumental Support Subscale

    Time frame: End of intervention (12 weeks)

    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.

  21. Brief Coping With Problems Experienced (Brief COPE) - Behavioral Disengagement Subscale

    Time frame: End of intervention (12 weeks)

    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.

  22. Brief Coping With Problems Experienced (Brief COPE) - Venting Subscale

    Time frame: End of intervention (12 weeks)

    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.

  23. Brief Coping With Problems Experienced (Brief COPE) - Positive Reframing Subscale

    Time frame: End of intervention (12 weeks)

    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.

  24. Brief Coping With Problems Experienced (Brief COPE) - Planning Subscale

    Time frame: End of intervention (12 weeks)

    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.

  25. Brief Coping With Problems Experienced (Brief COPE) - Humor Subscale

    Time frame: End of intervention (12 weeks)

    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.

  26. Brief Coping With Problems Experienced (Brief COPE) - Acceptance Subscale

    Time frame: End of intervention (12 weeks)

    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.

  27. Brief Coping With Problems Experienced (Brief COPE) - Religion Subscale

    Time frame: End of intervention (12 weeks)

    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.

  28. Brief Coping With Problems Experienced (Brief COPE) - Self-Blame Subscale

    Time frame: End of intervention (12 weeks)

    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.

  29. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study 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

Acronym: BEHAB

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2018
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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