N/A
N=52
Behavioral Activation-Rehabilitation to Improve Depressive Symptoms & Physical Function After Acute Respiratory Failure
Respiratory Insufficiency · Depression · Rehabilitation · Critical Care
Bottom Line
View on ClinicalTrials.gov: NCT03431493 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Feasibility Measure Per Participant — 0.8 proportion of intended visits
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral Activation - Rehabilitation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility Measure Per Participant |
0.8 | — |
| PRIMARY Total Feasibility Measure |
0.94 | — |
| PRIMARY Feasibility Measure/Assess Loss to Follow-up |
0.88; 0.93 | — |
| PRIMARY Feasibility Measure |
0.3; 0.4 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale |
6.6; 6.5 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) - Depression Subscale |
6.9; 5.0 | — |
| SECONDARY Personal Health Questionnaire - 8 Item Version (PHQ-8) |
9.3; 6.0 | — |
| SECONDARY Activity Measure for Post-Acute Care Computer Adaptive Test (AMPAC-CAT) - Basic Mobility Score |
62.4; 61.4 | — |
| SECONDARY EQ-5D-5L - Utility Score |
0.66; 0.80 | — |
| SECONDARY Healthcare Utilization - Readmissions |
5; 2 | — |
| SECONDARY Healthcare Utilization - Ever Utilized Mental Health Care |
4; 2 | — |
| SECONDARY Healthcare Utilization - Rehabilitation |
12; 13 | — |
| SECONDARY Behavioral Activation for Depression SCALE (BAS) |
95.3; 104.0 | — |
| SECONDARY Connor-Davidson Resilience Scale (CD RISC) |
72.3; 78.5 | — |
| SECONDARY Number of Phone Attempts Needed by the OT to Reach the Participant for Each Session |
— | — |
| SECONDARY Percentage of Sessions Fully Completed and Partially Completed |
0.94 | — |
| SECONDARY Montreal Cognitive Assessment (MoCA) - BLIND |
18.6; 17.8 | — |
| SECONDARY Impact of Events Scale - Revised (IES-R) |
0.97; 0.85 | — |
| SECONDARY Brief Coping With Problems Experienced (Brief COPE) - Self Distraction Subscale |
4.8; 4.2 | — |
| SECONDARY Brief Coping With Problems Experienced (Brief COPE) - Active Coping Subscale |
5.7; 5.8 | — |
| SECONDARY Brief Coping With Problems Experienced (Brief COPE) - Denial Subscale |
3.4; 3.3 | — |
| SECONDARY Brief Coping With Problems Experienced (Brief COPE) - Substance Use Subscale |
2.1; 2.1 | — |
| SECONDARY Brief Coping With Problems Experienced (Brief COPE) - Emotional Support Subscale |
5.7; 6.0 | — |
| SECONDARY Brief Coping With Problems Experienced (Brief COPE) - Instrumental Support Subscale |
4.6; 5.4 | — |
| SECONDARY Brief Coping With Problems Experienced (Brief COPE) - Behavioral Disengagement Subscale |
3.1; 2.4 | — |
| SECONDARY Brief Coping With Problems Experienced (Brief COPE) - Venting Subscale |
4.2; 3.5 | — |
| SECONDARY Brief Coping With Problems Experienced (Brief COPE) - Positive Reframing Subscale |
5.2; 5.1 | — |
| SECONDARY Brief Coping With Problems Experienced (Brief COPE) - Planning Subscale |
5.6; 5.6 | — |
| SECONDARY Brief Coping With Problems Experienced (Brief COPE) - Humor Subscale |
3.5; 4.0 | — |
| SECONDARY Brief Coping With Problems Experienced (Brief COPE) - Acceptance Subscale |
6.6; 6.7 | — |
| SECONDARY Brief Coping With Problems Experienced (Brief COPE) - Religion Subscale |
5.3; 5.5 | — |
| SECONDARY Brief Coping With Problems Experienced (Brief COPE) - Self-Blame Subscale |
3.8; 3.5 | — |
| SECONDARY Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (SCID-5) |
— | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT03431493). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.