Behavioral Activation Therapy for Depression After Respiratory Failure

(BEHAB Trial)

Overseen By Ann M Parker

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Cognitive impairment, Non-English, Homelessness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals who have survived serious breathing problems in the ICU and now face depression and physical challenges. The treatment, called Behavioral Activation - Rehabilitation, combines therapy for depression with physical rehabilitation, delivered through phone calls and home visits. The goal is to determine if this approach is practical and can enhance recovery. Suitable participants include those who were on life support in the ICU and now experience at least mild depression. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve recovery strategies for ICU survivors.

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.

What prior data suggests that this therapy is safe for patients recovering from respiratory failure?

Research has shown that Behavioral Activation - Rehabilitation is generally well-tolerated by individuals who have recovered from respiratory failure. This treatment aims to enhance mood and physical abilities by addressing mental and physical health needs simultaneously. While specific data on side effects for this treatment is limited, similar therapies have demonstrated good results for depression with few side effects. Additionally, since this trial is not in its early stages, previous research likely indicates that the treatment is safe enough for further testing. This information should reassure those considering participation in the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Behavioral Activation Therapy for depression after respiratory failure because it offers a new approach by focusing on engaging patients in meaningful activities to improve mood, rather than relying solely on medication. While standard treatments for depression typically involve antidepressants or talk therapy, this method empowers patients to take an active role in their recovery. This therapy can be particularly beneficial for those who may not respond well to medication or prefer a non-pharmacological approach. By targeting behavior and activity levels, it aims to break the cycle of inactivity and depressive symptoms, potentially offering quicker and more sustainable improvements in mood.

What evidence suggests that Behavioral Activation - Rehabilitation might be an effective treatment for depression after respiratory failure?

Research has shown that Behavioral Activation Therapy, which participants in this trial may receive, effectively treats depression. It encourages activities that improve mood, particularly benefiting those recovering from breathing problems. Studies have found that combining this therapy with physical rehabilitation addresses both mental and physical issues, leading to better overall recovery. For patients experiencing depression after breathing difficulties, this therapy could enhance both mental health and physical abilities. Early results suggest it is a promising method for managing these combined challenges. ^{1 2 3 4 5}

Who Is on the Research Team?

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

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?

Group I: Behavioral Activation - Rehabilitation Experimental Treatment 1 Intervention

Behavioral Activation - Rehabilitation

Group II: Usual Care Control Active Control 1 Intervention

Usual Care Control

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 randomized controlled trial involving 108 patients in Pakistan, culturally adapted Behavioral Activation therapy for Muslims (BA-M) was found to be more effective than Cognitive Behavior Therapy (CBT) in reducing depression symptoms, with a significant improvement of 1.95 units in PHQ-9 scores (P = 0.006).

Patients receiving BA-M also experienced better retention in therapy, attending an average of 0.75 more sessions than those in the CBT group (P = 0.013), and showed significant improvements in quality of life across physical, psychological, and social domains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized control trial of a culturally adapted behavioral activation therapy for Muslim patients with depression in Pakistan. Dawood, S., Mir, G., West, RM.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

This study is the first randomized controlled trial examining the effectiveness of a behavioral activation (BA) program specifically for treating depression in patients with advanced cancer, involving 38 participants across three sites in Japan.

The primary outcome measure is the Beck Depression Inventory-II (BDI-II) score, and the results are expected to provide evidence for BA as a feasible and acceptable intervention to improve mood and quality of life in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation for depression in patients with advanced cancer: study protocol for a multicenter randomized controlled trial. Hirayama, T., Ogawa, Y., Ogawa, A., et al.[2023]

A study involving seven patients with bipolar depression analyzed 2,480 hours of self-reported activities, revealing that movement-related activities were linked to the highest pleasure scores, suggesting that physical activity may enhance mood.

The research demonstrated the feasibility of using a data-driven approach to identify behavioral patterns, which could inform therapists and lead to the development of digital solutions for behavioral activation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data-Driven Learning in High-Resolution Activity Sampling From Patients With Bipolar Depression: Mixed-Methods Study. Rohani, DA., Tuxen, N., Quemada Lopategui, A., et al.[2020]

Behavioral activation (BA) is an effective treatment for depression, but many patients still experience treatment failure due to various factors, such as difficulty understanding the treatment rationale and behavioral noncompliance.

A case study of a depressed breast cancer patient highlights these challenges and suggests that improving patient awareness of life values and enhancing contingency management could help reduce failure rates in BA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment failure in behavior therapy: focus on behavioral activation for depression. Hopko, DR., Magidson, JF., Lejuez, CW.[2022]

In a study of 313 patients with major depressive disorder, internet-based behavioral activation significantly reduced depressive symptoms by increasing engagement in enjoyable activities, with a measurable effect observed after 4 weeks.

The findings suggest that clinicians and patients should expect a 4-week period for activation levels to improve before seeing a notable reduction in depression symptoms, which typically occurs around 6 weeks into the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Explaining the Efficacy of an Internet-Based Behavioral Activation Intervention for Major Depression: A Mechanistic Study of a Randomized-Controlled Trial. Fu, Z., Burger, H., Arjadi, R., et al.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation. Huguet, A., Miller, A., Kisely, S., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation for PTSD: A meta-analysis. Etherton, JL., Farley, R.[2022]

Behavioral Activation (BA) is a well-supported psychotherapy for depression that has evolved over the years, incorporating various techniques such as activity monitoring, scheduling, and skills training, which have empirical support as effective components.

While some techniques like activity scheduling and relaxation training have been validated as effective on their own, others are more effective when used as part of a comprehensive treatment package, highlighting the importance of a tailored approach in BA interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is behavioral activation? A review of the empirical literature. Kanter, JW., Manos, RC., Bowe, WM., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03431493

Behavioral Activation-Rehabilitation to Improve Depressive ... ... After Acute Respiratory Failure (BEHAB) ... Respiration Disorders. Respiratory Tract Diseases. Behavioral Symptoms. Behavior. Respiratory Insufficiency.

2. trialx.com trialx.com/clinical-trials/listings/240976/behavioral-activation-rehabilitation-to-improve-depressive-symptoms-physical-function-after-acute-respiratory-failure/

Behavioral Activation-Rehabilitation to Improve Depressive ... A growing number of Acute Respiratory Failure (ARF) survivors are burdened by depressive symptoms and physical impairments that last for years ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11552036/

Behavioral Activation Therapy for Depression Led by Health ... A narrative report was conducted to summarize the extracted data of the following outcomes ... Depression and chronic heart failure in the elderly ...

4. withpower.com withpower.com/trial/behavioral-activation-therapy-for-depression-after-respiratory-failure-6df73

Behavioral Activation Therapy for Depression After ... Behavioral Activation Therapy for Depression After Respiratory Failure ... Behavioral activation (BA) is an effective treatment for depression, but many ...

5. thejcn.com thejcn.com/DOIx.php?id=10.3988/jcn.2024.0148

Behavioral Activation and Brain Network Changes in ... Failure of anterior cingulate activation and connectivity with the amygdala during implicit regulation of emotional processing in ...