Group Telehealth Behavioral Cough Suppression Therapy

Group Telehealth Behavioral Cough Suppression Therapy Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Refractory Chronic Cough
• Intervention / Treatment: Behavioral: Behavioral Treatment

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jane E Reynolds, PhD; Phone Number: 406-243-2138; Email: jane.reynolds@mso.umt.edu
• Study Contact Backup: Name: Laurie J Slovarp, PhD; Phone Number: 406-243-2107; Email: laurie.slovarp@mso.umt.edu

Study Locations

• United States
  • Montana
    • Missoula, Montana, United States, 59812
      • Recruiting
      • University of Montana
      • Contact: Jane E Reynolds, PhD; Phone Number: 406-243-2138; Email: jane.reynolds@mso.umt.edu
      • Contact: Laurie J Slovarp, PhD; Phone Number: 406-243-2107; Email: laurie.slovarp@mso.umt.edu
      • Contact: Laurie J Slovarp, PhD
      • Contact: Jane E Reynolds, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• At least 18 years old
• Predominantly dry cough for at least 8 weeks
• Evaluated and treated by at least one physician for cough
• 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
• Reliable internet access
• Willing to agree to maintain confidentiality of personal information (including names) related to others in the study

Exclusion Criteria:

• Under age 18
• Coughing up blood
• Current smoker of any substance
• History of smoking or 10 or more years
• Diagnosed with a chronic lung condition (e.g., COPD, emphysema, lung cancer, idiopathic pulmonary fibrosis, chronic bronchitis, asthma)? (NOTE: If a patient has been told their cough may be (or is likely) due to asthma but they have not had any formal lung testing and asthma treatments have not helped your cough, we don't consider this a formal asthma diagnosis and will not exclude them from the study.)
• Diagnosed currently or in the past with head and neck cancer (i.e., cancer of the mouth, nose, or throat).
• Complaints of swallowing difficulty
• Taking any of the following medications, which have a known side effect of cough: 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)
• Prior BCST treatment with an SLP or respiratory therapist

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Telehealth Behavioral Cough Suppression Therapy	Behavioral: Behavioral Treatment; Behavioral cough suppression therapy delivered in a group setting via telehealth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leicester Cough Questionnaire	The Leicester Cough Questionnaire is a 19-item self-report questionnaire that is valid and reliable, and repeatable every two weeks. The total possible score is 21. The higher the score the better the cough-related quality of life.	Baseline, one-week post-treatment, and one-month post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of Severity Scale in Chronic Cough	The Patient Global Impression of Severity Scale in Chronic Cough involves the patient answering the question "how do you rate your overall current cough severity?" with options of "no problem, mild, moderate, or severe problem."	Baseline, every treatment session (4-6 treatment sessions, one treatment session per week), and one-month post-treatment

Collaborators and Investigators

• Sponsor: University of Montana

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Estimated): November 27, 2024

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Chronic Cough; Cough
• Other Study ID Numbers: IRB-FY2024-36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No