54 Participants Needed

Behavioral Activation Therapy for Depression After Respiratory Failure

(BEHAB Trial)

AM
AM
Overseen ByAnn M Parker
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is Behavioral Activation Therapy safe for humans?

Behavioral Activation Therapy has been used safely for treating depression and other conditions like PTSD, with no major safety concerns reported in the studies available.12345

How is Behavioral Activation Therapy unique for treating depression after respiratory failure?

Behavioral Activation Therapy is unique because it focuses on increasing engagement in enjoyable activities to boost positive reinforcement, which can be particularly beneficial for patients recovering from respiratory failure who may struggle with depression. Unlike other therapies, it can be delivered by practitioners with less psychological training, making it accessible and suitable for various settings.16789

Who Is on the Research Team?

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Ann M Parker, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Living at home before the current admission (not in a facility)
I experience mild depression symptoms.
I was in the ICU for over 24 hours for severe breathing problems needing special breathing support.

Exclusion Criteria

You already have problems with your memory or thinking.
You are currently abusing drugs or have a serious mental illness.
Lack of access to telephone or inability to use telephone independently
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Behavioral Activation and physical rehabilitation via telephone and 2 home visits over 12 weeks

12 weeks
2 home visits, multiple telephone sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Behavioral Activation - Rehabilitation
Trial Overview 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.
How Is the Trial Designed?
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 Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Published Research Related to This Trial

In a 9-week randomized controlled trial involving 78 patients with major depression, the study found that both expected mastery and pleasure from behavioral activation tasks were strongly correlated with improvements in depression severity.
The results suggest that the anticipation of pleasure from planned activities may be more important for the effectiveness of behavioral activation than the actual pleasure experienced, highlighting the role of meaningful engagement in treatment.
Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression?Furukawa, TA., Imai, H., Horikoshi, M., et al.[2019]
Behavioral activation (BA) has shown significant effectiveness in reducing PTSD symptoms, with a large effect size (Hedges's g = 1.484) compared to wait-list controls, based on a meta-analysis of 8 studies involving 564 participants.
BA also led to improvements in related issues such as anxiety, grief, and depression, with effect sizes ranging from moderate to large, indicating its potential as a versatile treatment for PTSD.
Behavioral activation for PTSD: A meta-analysis.Etherton, JL., Farley, R.[2022]
A systematic review of nine randomized controlled trials involving 2157 adult participants found that guided Internet-based behavioral activation (BA) is effective in reducing depression and anxiety, showing promising results compared to other treatments like physical activity and psychoeducation.
While Internet-based BA demonstrated non-inferior efficacy to other behavioral therapies and mindfulness, the overall quality of evidence was low to moderate, indicating a need for more rigorous studies to confirm its effectiveness in clinical settings.
A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation.Huguet, A., Miller, A., Kisely, S., et al.[2019]

Citations

Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression? [2019]
Behavioral activation for PTSD: A meta-analysis. [2022]
A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation. [2019]
Behavioral activation for depression in patients with advanced cancer: study protocol for a multicenter randomized controlled trial. [2023]
Data-Driven Learning in High-Resolution Activity Sampling From Patients With Bipolar Depression: Mixed-Methods Study. [2020]
Treatment failure in behavior therapy: focus on behavioral activation for depression. [2022]
What is behavioral activation? A review of the empirical literature. [2022]
Explaining the Efficacy of an Internet-Based Behavioral Activation Intervention for Major Depression: A Mechanistic Study of a Randomized-Controlled Trial. [2022]
Randomized control trial of a culturally adapted behavioral activation therapy for Muslim patients with depression in Pakistan. [2023]
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