Respiratory InsufficiencyBEHABNCT03431493
Behavioral Activation-Rehabilitation to Improve Depressive Symptoms & Physical Function After Acute Respiratory Failure
A study testing Behavioral Activation - Rehabilitation in people with Respiratory Insufficiency and Depression, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Respiratory Insufficiency, Depression, Rehabilitation
- What is being tested?
- Behavioral Activation - Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2018to 18 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Respiratory Insufficiency, Depression, Rehabilitation, Critical Care
- Being tested
- Behavioral Activation - Rehabilitation
- Medical subject headings
- Respiratory Insufficiency, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation - RehabilitationBehavioural
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 group | Role | What they receive |
|---|---|---|
| Behavioral Activation - Rehabilitation | Experimental | Behavioral Activation - Rehabilitation Receives: Behavioral: Behavioral Activation - Rehabilitation |
| Usual Care Control | No intervention | Usual Care Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: End of intervention (12 weeks)
Feasibility Measure
Average number of patients enrolled per month over 12 weeks
Measured: End of intervention (12 weeks)
Secondary outcomes (29)
Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale
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).
Measured: End of intervention (12 weeks)
Hospital Anxiety and Depression Scale (HADS) - Depression Subscale
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).
Measured: End of intervention (12 weeks)
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. Higher score more symptoms.
Measured: End of intervention (12 weeks)
Activity Measure for Post-Acute Care Computer Adaptive Test (AMPAC-CAT) - Basic Mobility Score
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.
Measured: End of intervention (12 weeks)
EQ-5D-5L - Utility Score
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.
Measured: End of intervention (12 weeks)
Healthcare Utilization - Readmissions
Patient interview to assess the following end of study (ie ~12 weeks) variable: number of patients with inpatient readmissions
Measured: End of intervention (12 weeks)
Healthcare Utilization - Ever Utilized Mental Health Care
Patient interview to assess the following end of study (ie ~12 weeks) variable: number of participants who ever utilized outpatient mental health
Measured: end of intervention (12 weeks)
Healthcare Utilization - Rehabilitation
Patient interview to assess the following end of study (ie ~12 weeks) variable: number of patients who ever utilized physical rehabilitation services
Measured: end of intervention (12 weeks)
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. Score range 0 to 150. Higher scores indicate greater activation.
Measured: End of intervention (12 weeks)
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.
Measured: End of intervention (12 weeks)
Number of Phone Attempts Needed by the OT to Reach the Participant for Each Session
Measure of adherence
Measured: End of intervention (12 weeks)
Percentage of Sessions Fully Completed and Partially Completed
Measure of adherence for intervention group
Measured: End of intervention (12 weeks)
Montreal Cognitive Assessment (MoCA) - BLIND
Measure of cognitive impairment. Score range 0 - 22. Higher scores indicate better cognitive function.
Measured: End of intervention (12 weeks)
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). Higher score indicates more stress symptoms.
Measured: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Self Distraction Subscale
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.
Measured: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Active Coping Subscale
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.
Measured: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Denial Subscale
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.
Measured: end of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Substance Use Subscale
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.
Measured: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Emotional Support Subscale
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.
Measured: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Instrumental Support Subscale
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.
Measured: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Behavioral Disengagement Subscale
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.
Measured: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Venting Subscale
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.
Measured: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Positive Reframing Subscale
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.
Measured: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Planning Subscale
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.
Measured: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Humor Subscale
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.
Measured: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Acceptance Subscale
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.
Measured: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Religion Subscale
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.
Measured: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Self-Blame Subscale
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.
Measured: End of intervention (12 weeks)
Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (SCID-5)
A clinical interview to assess depressive symptoms. This is a qualitative assessment.
Measured: End of intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start2 Mar 2018
- Primary completion18 Jul 2024
- Study completion18 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Ann M Parker, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431493
- Sponsor's protocol ID
- IRB00143231
- Other IDs
- K23HL138206
- Acronym
- BEHAB
- Status last verified
- Sep 2025
- First submitted
- 6 Feb 2018
- Last updated
- 22 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03431493
- Acronym / sponsor ID
- BEHAB / IRB00143231
- Conditions
- Respiratory Insufficiency, Depression, Rehabilitation, Critical Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Posted 19 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation - Rehabilitation | Experimental | Behavioral: Behavioral Activation - RehabilitationBehavioral Activation - Rehabilitation |
| Usual Care Control | No intervention | –Usual Care Control |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥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):
- At least mild depressive symptoms (score ≥2 on PHQ-2 scale)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Activation - RehabilitationParticipants 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. | Behavioural | Behavioral Activation - Rehabilitation |
Primary outcome
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.
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
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)
Average number of patients enrolled per month over 12 weeks
29 secondary outcomes
Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale
Time frame: End of intervention (12 weeks)
Hospital Anxiety and Depression Scale (HADS) - Depression Subscale
Time frame: End of intervention (12 weeks)
Personal Health Questionnaire - 8 Item Version (PHQ-8)
Time frame: End of intervention (12 weeks)
Activity Measure for Post-Acute Care Computer Adaptive Test (AMPAC-CAT) - Basic Mobility Score
Time frame: End of intervention (12 weeks)
EQ-5D-5L - Utility Score
Time frame: End of intervention (12 weeks)
Healthcare Utilization - Readmissions
Time frame: End of intervention (12 weeks)
Healthcare Utilization - Ever Utilized Mental Health Care
Time frame: end of intervention (12 weeks)
Healthcare Utilization - Rehabilitation
Time frame: end of intervention (12 weeks)
Behavioral Activation for Depression SCALE (BAS)
Time frame: End of intervention (12 weeks)
Connor-Davidson Resilience Scale (CD RISC)
Time frame: End of intervention (12 weeks)
Number of Phone Attempts Needed by the OT to Reach the Participant for Each Session
Time frame: End of intervention (12 weeks)
Percentage of Sessions Fully Completed and Partially Completed
Time frame: End of intervention (12 weeks)
Montreal Cognitive Assessment (MoCA) - BLIND
Time frame: End of intervention (12 weeks)
Impact of Events Scale - Revised (IES-R)
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Self Distraction Subscale
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Active Coping Subscale
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Denial Subscale
Time frame: end of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Substance Use Subscale
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Emotional Support Subscale
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Instrumental Support Subscale
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Behavioral Disengagement Subscale
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Venting Subscale
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Positive Reframing Subscale
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Planning Subscale
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Humor Subscale
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Acceptance Subscale
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Religion Subscale
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Self-Blame Subscale
Time frame: End of intervention (12 weeks)
Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (SCID-5)
Time frame: End of intervention (12 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Respiratory Insufficiency
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann M Parker, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation - Rehabilitation in people with Respiratory Insufficiency and Depression, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Measure Per Participant (time frame: End of intervention (12 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.