Group Telehealth Behavioral Cough Suppression Therapy

NCT06706765 | Recruiting Early Phase 1

• 1 other identifier: IRB-FY2024-36
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Refractory Chronic Cough

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Global Impression of Severity Scale in Chronic Cough

  Baseline, every treatment session (4-6 treatment sessions, one treatment session per week), and one-month post-treatment

Study Arms (1)

Group Telehealth Behavioral Cough Suppression Therapy

EXPERIMENTAL

Behavioral: Behavioral Treatment

Interventions

Behavioral Treatment BEHAVIORAL

Behavioral cough suppression therapy delivered in a group setting via telehealth.

Group Telehealth Behavioral Cough Suppression Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Montana: lead

Study Sites (1)

University of Montana

Missoula, Montana, 59812, United States

RECRUITING

MeSH Terms

Conditions

Chronic Cough

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Jane E Reynolds, PhD

CONTACT

406-243-2138; jane.reynolds@mso.umt.edu

Laurie J Slovarp, PhD

CONTACT

406-243-2107; laurie.slovarp@mso.umt.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: November 27, 2024
• Study Start: March 22, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-08

Locations

US (1)