Behavioral Therapy for Chronic Cough

Overseen By Laurie J Slovarp, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Montana

Must not be taking: Ace inhibitors

Disqualifiers: Chronic lung condition, Head/neck cancer, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 4-6 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to manage stubborn chronic coughs that haven't improved with regular treatment. It employs a group telehealth model to deliver behavioral cough suppression therapy, a proven method provided by trained speech-language pathologists. The trial aims to make this therapy more accessible, especially for those in rural areas. Individuals with a dry cough lasting over 8 weeks, who have consulted a doctor and have clear chest scans, could be suitable candidates. Participants need reliable internet and a device with a camera for telehealth sessions. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking certain medications that have a known side effect of cough, like Lisinopril or Enalapril.

What prior data suggests that this behavioral therapy is safe for managing chronic cough?

Research has shown that Behavioral Cough Suppression Therapy (BCST) effectively manages long-term coughs. This therapy has significantly reduced coughing in many individuals, with some studies indicating up to 88% effectiveness in treating chronic cough.

BCST is a safe option because it involves no drugs, making it generally easy to tolerate. Reports of adverse side effects are absent. The therapy teaches techniques to control coughing and maintain throat health, making it a safe choice for those whose chronic cough has not improved with other treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for chronic cough rely on medications to suppress the cough reflex. However, the behavioral therapy being explored offers a fresh approach by teaching patients techniques to control their coughing through telehealth sessions. This method is unique because it empowers patients to manage their symptoms actively without relying on medication, potentially reducing side effects and improving quality of life. Researchers are excited because this therapy could offer a non-drug alternative that is accessible and easy to implement, especially for those who haven't found relief with traditional treatments.

What evidence suggests that behavioral cough suppression therapy is effective for managing refractory chronic cough?

Research has shown that behavioral cough suppression therapy (BCST), which participants in this trial will receive, can significantly help individuals with a persistent cough. In studies, patients who underwent BCST reported substantial improvements in their cough symptoms. Specifically, 92.5% of patients experienced reduced coughing after an average of 1.7 sessions. Many patients also achieved better scores on the Leicester Cough Questionnaire, which assesses the impact of a cough on daily life. These findings suggest that BCST could effectively manage a chronic cough, even when other treatments have failed. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with a persistent cough lasting over 8 weeks, known as refractory chronic cough (RCC), which hasn't improved with usual medical treatments. It's especially aimed at those who may have difficulty accessing specialized care due to living in rural areas.

Inclusion Criteria

I have reliable internet access.

Obtained a chest X-ray or chest CT scan specifically related to the cough with unremarkable results

Access to a computer or tablet that includes a camera and able to use the device independently

Exclusion Criteria

Current smoker of any substance

I am taking medication that can cause coughing.

History of smoking for 10 or more years

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive behavioral cough suppression therapy (BCST) in a group telehealth setting

4-6 weeks

4-6 visits (virtual, one per week)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (virtual, one-month post-treatment)

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Treatment

Trial Overview

The study tests the effectiveness of Behavioral Cough Suppression Therapy (BCST) when delivered through group telehealth by trained speech-language pathologists, compared to traditional one-on-one sessions.

How Is the Trial Designed?

Group I: Group Telehealth Behavioral Cough Suppression Therapy Experimental Treatment 1 Intervention

Behavioral Treatment is already approved in United States, European Union for the following indications:

Approved in United States as Cognitive Behavioral Therapy for Insomnia for:

• Insomnia
• Chronic pain
• Depression
• Inflammation associated with Crohn's disease

Approved in European Union as Cognitive Behavioral Therapy for Insomnia for:

• Insomnia
• Chronic pain
• Depression
• Inflammation associated with Crohn's disease

Who Is Running the Clinical Trial?

University of Montana

Lead Sponsor

Trials

29

Recruited

4,700+

Published Research Related to This Trial

Cognitive Behavioral Therapy for Insomnia (CBT-I) is an effective multi-component treatment for chronic insomnia, which affects 6-10% of the population and can lead to various health issues; it is recommended as the first-line intervention for insomnia.

Despite its proven efficacy and comprehensive evidence base, CBT-I is not widely disseminated, highlighting the need for increased awareness and training among clinicians and researchers to improve treatment access for those suffering from insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia (CBT-I): A Primer. Walker, J., Muench, A., Perlis, ML., et al.[2023]

Cognitive behavioral therapy for insomnia (CBT-I) is recognized as the first-line treatment for both uncomplicated insomnia and insomnia associated with other chronic disorders, demonstrating its broad efficacy.

This review aims to summarize efficacy data across various clinical and demographic factors and to outline future research and implementation strategies for CBT-I, highlighting its importance in treating sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

We know CBT-I works, now what? Muench, A., Vargas, I., Grandner, MA., et al.[2022]

Cognitive behavior therapy for insomnia (CBT-I) shows moderate to large treatment effects (Cohen's d range of 0.35-2.2) for patients with insomnia related to various medical and psychiatric conditions, indicating its efficacy beyond primary insomnia.

Improving sleep through CBT-I may also lead to better outcomes in managing comorbid medical and psychological conditions, highlighting the need for further research on adapting CBT-I for specific disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. Smith, MT., Huang, MI., Manber, R.[2022]

Cognitive-behavioral therapy for insomnia (CBT-I) is the preferred treatment for chronic insomnia, but it faces challenges such as a lack of trained therapists and a low response rate among patients.

Alternative methods to CBT-I, including bibliotherapy, phone psychotherapy, brief behavioral therapy, and online CBT-I, are gaining interest, and hypnotics can be used alongside CBT-I to enhance its effectiveness or as a standalone treatment when CBT-I is not accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioral therapy and pharmacotherapy for chronic insomnia]. Pchelina, PV., Poluektov, MG.[2019]

Cognitive-behavioral therapy for insomnia (CBT-I) is recommended as the first-line treatment for chronic primary insomnia, which affects about 10% of adults and is associated with various health risks.

There is ongoing research into extending CBT-I to patients with insomnia related to medical and psychiatric conditions, but there is currently no consensus on the criteria for determining suitable candidates for this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Who is a candidate for cognitive-behavioral therapy for insomnia? Smith, MT., Perlis, ML.[2022]

A clinical study involving 123 insomnia patients followed for an average of 7.8 years showed that cognitive-behavioral therapy for insomnia (CBT-I) significantly improved insomnia severity and maintained its effects for up to 10 years after treatment.

Patients who relied solely on CBT-I techniques for managing relapses had better long-term outcomes compared to those who resorted to medication, highlighting the effectiveness of CBT-I as a first-choice treatment for insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term clinical effect of group cognitive behavioral therapy for insomnia: a case series study. Castronovo, V., Galbiati, A., Sforza, M., et al.[2019]

Cognitive Behavioral Therapy for insomnia (CBT-i) is an effective first-line treatment for chronic insomnia, showing significant improvements in sleep onset latency (SOL) by about 19 minutes and wake after sleep onset (WASO) by about 26 minutes based on a review of 20 studies involving 1162 participants.

The benefits of CBT-i, which includes techniques like cognitive therapy and sleep hygiene, appear to be sustained over time, and importantly, no adverse effects were reported, making it a safe alternative to pharmacological treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Trauer, JM., Qian, MY., Doyle, JS., et al.[2022]

Cognitive behavioral therapy for insomnia (CBT-I) was effective in improving insomnia symptoms over a 24-month follow-up among 59 media workers, with 62% of participants showing moderate improvement.

The study found that working hour arrangements did not impact the effectiveness of CBT-I, indicating that this treatment can benefit both daytime and shift workers with chronic insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for chronic insomnia in occupational health services: analyses of outcomes up to 24 months post-treatment. Järnefelt, H., Sallinen, M., Luukkonen, R., et al.[2018]

In a study of 188 adults with persistent insomnia, full cognitive behavior therapy (CBT) showed the greatest overall improvements in sleep, with 67.3% of participants responding positively after treatment, compared to 67.4% for behavior therapy (BT) and 42.4% for cognitive therapy (CT).

While BT provided quicker results, its benefits were not as long-lasting, with a significant drop in response rates at the 6-month follow-up, whereas CT showed slower but sustained improvements over time, highlighting the different effectiveness trajectories of these therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy of behavior therapy, cognitive therapy, and cognitive behavior therapy for chronic insomnia: a randomized controlled trial. Harvey, AG., Bélanger, L., Talbot, L., et al.[2022]

A study involving 188 patients with insomnia found that cognitive behavior therapy (CBT) led to greater improvements in insomnia severity and overall health compared to cognitive therapy (CT) and behavior therapy (BT) after 12 months.

All three therapies (CT, BT, and CBT) were effective in reducing insomnia symptoms and improving daytime functioning, but CBT showed specific advantages, especially for patients with psychiatric comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twelve-month follow-up: Comparative efficacy of cognitive therapy, behavior therapy, and cognitive behavior therapy for patients with insomnia. Sarfan, LD., Morin, CM., Harvey, AG.[2023]

In a review of 99 randomized controlled trials on cognitive behavioral therapy for insomnia (CBTI), only 32.3% addressed adverse events, highlighting a significant gap in monitoring during psychological treatment compared to pharmacotherapy.

Only 7.1% of the studies met all criteria for adequate reporting of adverse events, indicating a need for improved standards in documenting potential negative effects of CBTI to ensure patient safety and treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of adverse events in cognitive behavioural therapy for insomnia: A systematic examination of randomised controlled trials. Condon, HE., Maurer, LF., Kyle, SD.[2021]

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1 Although medical treat- ment is generally successful for CC, cough can persist in a proportion of cases resulting in significant mor- bidity and detriment to ...