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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of intervention (12 weeks)
Awards & highlights
BEHAB Trial 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.Check my eligibility
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.See study design
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.
BEHAB Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience mild depression symptoms.
Select...
I was in the ICU for over 24 hours for severe breathing problems needing special breathing support.
Select...
I am 18 years old or older.
BEHAB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of intervention (12 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of intervention (12 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility measure
Feasibility measure per participant
Feasibility measure/Assess loss to follow-up
+1 moreSecondary outcome measures
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 moreBEHAB 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
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,275 Previous Clinical Trials
14,840,570 Total Patients Enrolled
57 Trials studying Depression
29,561 Patients Enrolled for Depression
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,848 Previous Clinical Trials
47,818,208 Total Patients Enrolled
42 Trials studying Depression
68,490 Patients Enrolled for Depression
Ann M Parker, MDPrincipal InvestigatorJohns Hopkins University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You already have problems with your memory or thinking.You are currently abusing drugs or have a serious mental illness.You are currently in jail or prison.You have thoughts of hurting yourself.I will need complex medical care soon after I leave the hospital.You are homeless or live more than 50 miles away from the study location.I have not been sent home from the hospital.I experience mild depression symptoms.I was in the ICU for over 24 hours for severe breathing problems needing special breathing support.I have been in the ICU for more than 30 days.I am 18 years old or older.I was bedbound before being admitted this time.The doctor thinks you might not live for more than 6 months.I am unable or unwilling to give my consent for participation.
Research Study Groups:
This trial has the following groups:- Group 1: Behavioral Activation - Rehabilitation
- Group 2: Usual Care Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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