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NCT Number: NCT06706765

Group Telehealth Behavioral Cough Suppression Therapy

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral Treatment

Behavioral

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

Primary outcomes

  1. Leicester Cough Questionnaire

    Time frame: Baseline, one-week post-treatment, and one-month post-treatment

    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.

Secondary outcomes

  1. Patient Global Impression of Severity Scale in Chronic Cough

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

    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."

Study contacts

Contact information is provided by the study sponsor or research team.

Jane E Reynolds, PhD

CONTACT

[email protected]

406-243-2138

Laurie J Slovarp, PhD

CONTACT

[email protected]

406-243-2107

Sponsors and collaborators

Lead sponsor

University of Montana

Other

Registry information

Official study title

Group Telehealth Behavioral Cough Suppression Therapy Pilot Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 27, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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