Brief, breath-focused ACT for adults with chronic cough

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, single-arm pilot study evaluating the feasibility, acceptability, and safety of a brief breath control–focused ACT intervention in adults with chronic cough. Eligible participants are adults 18-80 with a persistent cough lasting at least 8 weeks and normal chest imaging, identified through UNC Health records and prior outpatient visits. The intervention consists of Acceptance and Commitment Therapy sessions emphasizing breath control strategies. Outcomes focus on feasibility metrics, participant satisfaction, and any adverse events to guide future larger studies. The study is led by UNC Chapel Hill with NHLBI collaboration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Confirmed patient with UNC Health electronic medical record number (MRN) via medical chart review
* 18-80 years of age via medical chart review
* Completed outpatient clinical encounter within the prior 12 months with a provider in pulmonary medicine, gastroenterology, otolaryngology, and/or allergy at UNC Health via medical chart review, with documentation that chronic cough (lasting 8 weeks or longer) was listed as one of the reasons for the visit, with terminology such as, but not limited to chronic, ongoing, recurrent, persistent, lingering, refractory, longstanding, constant, continual, continuous, prolonged, intermittent, frequent, repetitive, unresolved, non-resolving, habitual, troublesome, bothersome, unmanaged, unexplained, idiopathic, progressive, worsening, treatment-resistant, and/or intractable
* Documented interpretation by provider of normal chest imaging, defined as a chest radiograph (X-ray) or computed tomography (CT) scan of the chest without clinically significant abnormalities contributing to chronic cough, within the prior 12 months obtained as part of the evaluation for chronic cough via medical chart review
* Documented judgment of provider within the prior 12 months that chronic cough was not primarily attributable to untreated or inadequately treated pulmonary, gastroesophageal, or sinonasal condition(s) via medical chart review
* Chronic cough of at least moderate severity (i.e., moderate, severe, very severe) via self-report using a screening questionnaire
* Score ≤ 14 on the Patient Health Questionnaire-9 (PHQ-9), indicating no greater than moderate depressive symptom severity (maximum score: 27), via self-report using a screening questionnaire
* Score of ≤ 14 on the Generalized Anxiety Disorder-7 (GAD-7), indicating no greater than moderate generalized anxiety symptoms (maximum score: 21), via self-report using a screening questionnaire
* Score of ≤ 10 on the Distress Questionnaire-5 (DQ5), indicating no elevated psychological distress (maximum score: 25), via self-report using a screening questionnaire
* Agree to participate in a program to learn new ways to manage chronic cough for 4 weeks via self-report using a screening questionnaire
* Able to participate in study activities with a facilitator scheduled during standard weekday business hours via self-report using a screening questionnaire
* Access to reliable internet connection and device capable of videoconferencing (e.g., computer, tablet, smartphone) via self-report using a screening questionnaire

Exclusion Criteria:

* Current smoking status via medical chart review
* Current use of angiotensin-converting enzyme (ACE) inhibitor medication(s) via medical chart review, including Benazepril/brand name: Lotensin; Captopril/brand name: Capoten; Enalapril/brand name: Vasotec; Fosinopril/brand name: Monopril; Lisinopril/brand name: Prinivil, Zestril; Moexipril/brand name: Univasc; Perindopril/brand name: Aceon; Quinapril/brand name: Accupril; Ramipril/brand name: Altace; and/or Trandolapril/brand name: Mavik
* Unable to read, understand, and speak English without an interpreter via medical chart review
* Documented cognitive, intellectual, developmental, or neurological conditions that could interfere with reliable self-report, comprehension, or completion of study procedures via medical chart review

Where it's running

• University of North Carolina at Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Carolyn Novaleski, Ph.D., CCC-SLP — University of North Carolina, Chapel Hill
• Study coordinator: Carolyn K. Novaleski, Ph.D., CCC-SLP
• Email: carolyn_novaleski@med.unc.edu
• Phone: 919-962-5965

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.