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

Trial Summary

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 data supports the idea that Behavioral Therapy for Chronic Cough is an effective treatment?

The available research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective for treating insomnia, which is a condition similar to chronic cough in terms of persistent symptoms. Studies indicate that CBT-I has long-term benefits, lasting up to several years, and is often preferred over medication due to its lasting effects. While the research specifically focuses on insomnia, the success of CBT-I in managing persistent symptoms suggests it could be similarly effective for chronic cough. ^{1 2 3 4 5}

What safety data exists for behavioral therapy for chronic cough?

The safety data for cognitive behavioral therapy for insomnia (CBT-I), which may be similar to behavioral therapy for chronic cough, indicates that adverse events are not consistently reported. A systematic examination of 99 randomized controlled trials found that only 32.3% addressed adverse events, and just 7.1% met all criteria for adequate reporting. While no consistent differences in adverse events were found between trial arms, the limited evidence and variability in reporting make it difficult to draw clear conclusions about safety. Recommendations have been made to improve monitoring and reporting of adverse events in psychological treatment trials. ^{2 6 7 8 9}

Is the treatment Behavioral Treatment (CBT-I) promising for the trial titled 'Behavioral Therapy for Chronic Cough'?

Yes, Cognitive Behavioral Therapy for Insomnia (CBT-I) is a promising treatment. It has been shown to be effective for improving sleep and has a large evidence base supporting its use for chronic insomnia, which is a common sleep disorder. ^{1 2 5 10 11}

What is the purpose of this trial?

The purpose of this study is to investigate the effectiveness of behavioral cough suppression therapy (BCST) in managing refractory chronic cough (RCC) within a group telehealth setting. RCC is a cough that has lasted at least 8 weeks and has not resolved with standard medical treatment. BCST is a research-based treatment provided by specialty-trained speech-language pathologists (SLPs) for patients with RCC. Although the treatment works very well for a large proportion of patients in a standard one-on-one format, there are a limited number of SLPs available to provide this treatment and patients living in rural areas do not typically have access to an SLP trained in BCST. If BCST can effectively be delivered in a group telehealth model, it would significantly improve accessibility to the treatment.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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) 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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparative efficacy of behavior therapy, cognitive therapy, and cognitive behavior therapy for chronic insomnia: a randomized controlled trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for chronic insomnia in occupational health services: analyses of outcomes up to 24 months post-treatment. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term clinical effect of group cognitive behavioral therapy for insomnia: a case series study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Twelve-month follow-up: Comparative efficacy of cognitive therapy, behavior therapy, and cognitive behavior therapy for patients with insomnia. [2023]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioral therapy and pharmacotherapy for chronic insomnia]. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Who is a candidate for cognitive-behavioral therapy for insomnia? [2022]

8. England pubmed.ncbi.nlm.nih.gov

We know CBT-I works, now what? [2022]

9. England pubmed.ncbi.nlm.nih.gov

Reporting of adverse events in cognitive behavioural therapy for insomnia: A systematic examination of randomised controlled trials. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. [2022]

11. Russia (Federation) pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia (CBT-I): A Primer. [2023]