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

NCT03431493 | Completed Results DMC

• 2 other identifiers: IRB00143231K23HL138206
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Insufficiency; Depression; Rehabilitation; Critical Care

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (29)

• 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)

Study Arms (2)

Behavioral Activation - Rehabilitation

EXPERIMENTAL

Behavioral Activation - Rehabilitation

Behavioral: Behavioral Activation - Rehabilitation

Usual Care Control

NO INTERVENTION

Usual Care Control

Interventions

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.

Behavioral Activation - Rehabilitation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Depression

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Ann Parker, MD, PhD
• Organization: Johns Hopkins University

aparke36@jhu.edu

443-287-2616

Study Officials

• Ann M Parker, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 13, 2018
• Study Start: March 2, 2018
• Primary Completion: July 18, 2024
• Study Completion: July 18, 2024
• Last Updated: September 22, 2025
• Results First Posted: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)