Internet-Behavioral Cough Suppression Therapy
Study Details
Study Description
Brief Summary
The goal of this randomized, placebo-controlled, clinical trial is to develop and test the efficacy of an Internet-based behavioral intervention for refractory chronic cough. The main questions it aims to answer are:
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What are the best recruitment pathways to find people living with refractory chronic cough in Montana?
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Is Internet-Behavioral Cough Suppression Therapy (iBCST) efficacious?
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Do iBCST participants find it satisfactory?
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Is using Hyfe research app to monitor cough frequency feasible in rural areas?
Participants will complete iBCST or a placebo treatment virtually. Some participants will take part in qualitative interviews and use Hyfe research app for ambulatory cough frequency monitoring.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Internet-Behavioral Cough Suppression Therapy Participants will watch treatment-specific educational and training videos and perform the training exercises as recommended. There are a total of five videos ranging from 2-5 minutes in length. Participants will be asked to watch the videos at least once weekly. Daily training exercises will be discussed in the videos and should take no more than a few minutes to complete every day. All exercises are non-invasive and are not physically demanding. Each week participants will complete a progress check question that will take less than one minute to answer, indicating whether they are watching the videos and completing the exercises as recommended. |
Behavioral: Internet-Behavioral Cough Suppression Therapy
Participants will access training modules to learn behavioral techniques and will implement them in daily life over a four-week period.
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| Sham Comparator: Sham Treatment Participants will watch sham treatment-specific educational and training videos and perform the training exercises as recommended. There are a total of five videos ranging from 2-5 minutes in length. Participants will be asked to watch the videos at least once weekly. Daily training exercises will be discussed in the videos and should take no more than a few minutes to complete every day. All exercises are non-invasive and are not physically demanding. Each week participants will complete a progress check question that will take less than one minute to answer, indicating whether they are watching the videos and completing the exercises as recommended. |
Behavioral: Sham Treatment
Participants will access training modules to learn behavioral techniques and will implement them in daily life over a four-week period.
|
Outcome Measures
Primary Outcome Measures
- Change in Cough-Related Quality of Life [Baseline, pre-intervention, and immediately after the intervention]
Cough-related quality of life will be measured with the Leicester Cough Questionnaire. This is a valid and reliable 19-item questionnaire measuring cough-related quality of life with a possible total score of 21 (a higher score indicates better quality of life). A change in 1.3 is considered clinically significant.
Secondary Outcome Measures
- Hourly Cough Rate [Baseline, pre-intervention, and immediately after the intervention]
Hourly cough frequency measured over one week.
Eligibility Criteria
Criteria
Inclusion Criteria:
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No barriers to using a computer or smartphone (e.g., no significant fine motor or visual problems).
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Internet and e-mail access and the ability to use it.
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Suffering from a cough lasting at least eight weeks that is:
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Largely unproductive (cough up no more than a few teaspoons worth of clear or white sputum or mucus in a 24-hour period).
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Report of cough triggered by identifiable stimuli including and not limited to any combination of the following: cold air, talking, laughing, taking a deep breath, exercise, crumbly foods, strong smells or odors, fumes from paint or cleaning sprays.
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Often preceded by the sensation of an urge-to-cough (e.g., tickle or itch) at the level of the throat.
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Self-report of receiving the following assessments for current cough symptoms with unremarkable results:
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Physical evaluation by at least one physician.
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Chest x-ray.
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Willingness to avoid other potential cough treatments during the course of the study (or alert study personnel if alternative treatment is implemented out of necessity).
Exclusion Criteria:
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Current smoker of any substance.
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Diagnosis of any of the following:
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Respiratory disease (e.g., chronic obstructive pulmonary disease, asthma)
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Neurogenic disease (e.g., Parkinson's disease, cerebrovascular disease)
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Head and neck cancer
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Self-report of difficulty swallowing since having chronic cough
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Use of the following medication:
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Angiotensin-converting enzyme inhibitor (ACE-I) in the past four weeks: benzapril (Lotensin), Captopril (Capoten), Enalapril/Enalaprilat (Vasotec oral and injectable), Fosinopril (Monopril), Lisinopril (Zestril and Prinivil), Moexipril (Univasc), Perindopril (Aceon), Quinapril (Accupril), Ramipril (Altace), and Trandolapril (Mavik).
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Use of a neuromodulator medication in the past 48 hours: Neurontin (Gabapentin) and amitriptyline.
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Individuals with dysphonia (abnormal voice; either self-reported or perceived by study personnel during enrollment interview) will be excluded unless they have had a normal laryngoscopy (endoscopic assessment of the larynx) by an otolaryngologist (ENT) within the past year specifically for their cough.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Montana
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 163-22