Internet-Behavioral Cough Suppression Therapy

University of Montana39 enrolled

Overview

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: * What are the best recruitment pathways to find people living with refractory chronic cough in Montana? * Is Internet-Behavioral Cough Suppression Therapy (iBCST) efficacious? * Do iBCST participants find it satisfactory? * 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cough Chronic Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * No barriers to using a computer or smartphone (e.g., no significant fine motor or visual problems). * Internet and e-mail access and the ability to use it. * Suffering from a cough lasting at least eight weeks that is: * Largely unproductive (cough up no more than a few teaspoons worth of clear or white sputum or mucus in a 24-hour period). * 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. * Often preceded by the sensation of an urge-to-cough (e.g., tickle or itch) at the level of the throat. * Self-report of receiving the following assessments for current cough symptoms with unremarkable results: * Physical evaluation by at least one physician. * Chest x-ray. * 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: * Current smoker of any substance. * Diagnosis of any of the following: * Respiratory disease (e.g., chronic obstructive pulmonary disease, asthma) * Neurogenic disease (e.g., Parkinson's disease, cerebrovascular disease) * Head and neck cancer * Self-report of difficulty swallowing since having chronic cough * Use of the following medication: * 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). * Use of a neuromodulator medication in the past 48 hours: Neurontin (Gabapentin) and amitriptyline. * 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.

Outcomes

Primary Outcomes

Leicester Cough Questionnaire

Cough-related quality of life will be measured with the Leicester Cough Questionnaire (LCQ), a valid, reliable, and repeatable measure of cough-related quality of life. The LCQ is a 19-item questionnaire containing physical, psychological, and social domains. Scores for the LCQ include mean scores for each domain (ranging from 1 to 7) and a total score calculated as the sum of the domain scores (ranging from 3 to 21). A higher score indicates better quality of life. A change in 1.3 is considered clinically significant. The LCQ total score was the primary outcome measure in this study.

Time frame: Pre-treatment, one-week post-treatment, one-month post-treatment

Secondary Outcomes

Cough Severity Visual Analog Scale

Cough Severity Visual Analog Scale (VAS) is a 100-millimeter line with anchors of 0 "no problem" and 100 "worst possible problem" where participants place a mark to represent the severity of their current cough problem. A reduction of at least 30-millimeters is considered clinically meaningful for the Cough Severity VAS.

Time frame: Pre-intervention, one-week post-treatment, one-month post-treatment