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Behavioral Activation Therapy for Depression After Respiratory Failure (BEHAB Trial)

N/A
Recruiting
Led By Ann M Parker, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least mild depressive symptoms (score ≥2 on PHQ-2 scale)
Acute respiratory failure managed in the ICU > 24hrs with specific ventilation or oxygenation criteria
Must not have
Not discharged home from the hospital
ICU Length Of Stay (LOS) > 30 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of intervention (12 weeks)
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at a new therapy to help people who have survived respiratory failure and are struggling with depression and physical problems.

Who is the study for?
This trial is for adults over 18 who were living at home before ICU admission, experienced acute respiratory failure requiring intensive care for more than 24 hours, and have mild depressive symptoms. Excluded are those with long ICU stays, substance abuse or psychosis, severe prior disability, non-English speakers, homelessness or living far from the study site.
What is being tested?
The study tests a combined therapy approach delivered through phone calls and home visits to treat depression and improve physical function in patients who've had serious respiratory issues requiring life support.
What are the potential side effects?
Since this is a behavioral intervention focusing on mental health and physical rehabilitation rather than medication, side effects may include emotional discomfort during therapy sessions but are generally expected to be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I experience mild depression symptoms.
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I was in the ICU for over 24 hours for severe breathing problems needing special breathing support.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not been sent home from the hospital.
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I have been in the ICU for more than 30 days.
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I was bedbound before being admitted this time.
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I am unable or unwilling to give my consent for participation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of intervention (12 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of intervention (12 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility measure
Feasibility measure per participant
Feasibility measure/Assess loss to follow-up
+1 more
Secondary study objectives
Activity Measure for Post-Acute Care Computer Adaptive Test (AMPAC-CAT)
Behavioral Activation for Depression SCALE (BAS)
Brief Coping with Problems Experienced (Brief COPE)
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Behavioral Activation - RehabilitationExperimental Treatment1 Intervention
Behavioral Activation - Rehabilitation
Group II: Usual Care ControlActive Control1 Intervention
Usual Care Control

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,712 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,889 Total Patients Enrolled
1 Trials studying Rehabilitation
30 Patients Enrolled for Rehabilitation
Ann M Parker, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Behavioral Activation - Rehabilitation Clinical Trial Eligibility Overview. Trial Name: NCT03431493 — N/A
Rehabilitation Research Study Groups: Behavioral Activation - Rehabilitation, Usual Care Control
Rehabilitation Clinical Trial 2023: Behavioral Activation - Rehabilitation Highlights & Side Effects. Trial Name: NCT03431493 — N/A
Behavioral Activation - Rehabilitation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03431493 — N/A
~3 spots leftby Jun 2025
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