Feasibility, Acceptability, and Safety Trial of Brief, Breath Control-Focused Acceptance and Commitment Therapy in Adults With Chronic Cough (FAST-COUGH)

Identifying Predictors of Treatment Response to Pharmacologic and Nonpharmacologic Interventions in Cough Hypersensitivity Syndrome

This study is a prospective, single-center, single-arm pilot trial. The primary research question is whether brief, breath control-focused Acceptance and Commitment Therapy (ACT) is feasible, acceptable, and safe in adults with chronic cough.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Cough
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy (ACT)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carolyn K. Novaleski, Ph.D., CCC-SLP; Phone Number: 919-962-5965; Email: carolyn_novaleski@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
      • Contact: Carolyn K. Novaleski, Ph.D., CCC-SLP; Phone Number: 919-962-5965; Email: carolyn_novaleski@med.unc.edu

Participation Criteria

Eligibility Criteria

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

Description

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

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: Acceptance and Commitment Therapy (ACT); Brief Acceptance and Commitment Therapy (ACT) combined with breath control techniques	Behavioral: Acceptance and Commitment Therapy (ACT); Brief Acceptance and Commitment Therapy (ACT) combined with breath control techniques. Treatment delivered once per week for 30 minutes each session for total of 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Proportion of participants in the target population expected to enroll in the study (numerator) out of all eligible individuals identified (denominator)	From screening and recruitment to enrollment
Retention rate	Proportion of participants enrolled in the study expected to complete the follow-up assessments (numerator) out of all participants initially enrolled in the study (denominator)	From enrollment to the end of treatment at 4 weeks
Adherence rate of session attendance	Proportion of participants enrolled in the study expected to attend sessions for at least 24 minutes (80%) of the 30-minute sessions (numerator) out of all participants initially enrolled in the study (denominator)	From enrollment to the end of treatment at 4 weeks
Ordinal scale of adherence to self-directed activities	Proportion of participants enrolled in the study expected to complete more than half (50%) of the self-directed activities (numerator) out of all participants initially enrolled in the study (denominator)	From enrollment to the end of treatment at 4 weeks
Likert scale of agreement for cough-related adherence barriers	Proportion of participants enrolled in the study who completed the follow-up assessments expected to strongly agree or agree that each of 11 cough-related items was a barrier to doing in the program	From enrollment to the end of treatment at 4 weeks
Likert scale of agreement for acceptability	Proportion of participants enrolled in the study who completed the follow-up assessments expected to strongly agree or agree that the program was acceptable	From enrollment to the end of treatment at 4 weeks
Likert scale of agreement for appropriateness	Proportion of participants enrolled in the study who completed the follow-up assessments expected to strongly agree or agree that the program was a good fit for people with chronic cough	From enrollment to the end of treatment at 4 weeks
Likert scale of agreement for burden	Proportion of participants enrolled in the study who completed the follow-up assessments expected to strongly agree or agree that the time and work the program took was reasonable	From enrollment to the end of treatment at 4 weeks
Distress Questionnaire-5 (DQ5)	Expected means of general levels of psychological distress at baseline and follow-up assessments, expected standard deviations, and proportion of participants who completed the follow-up assessments expected to have an increased score of 1 or greater in general levels of psychological distress	From enrollment to the end of treatment at 4 weeks
Binary scale for monitoring program-specific psychological distress	Proportion of participants enrolled in the study expected to report experiencing increased psychological distress specifically related to the program	From enrollment to the end of treatment at 4 weeks
Adverse events (AEs)	Proportion of participants enrolled in the study expected to report one or more adverse events (AEs) and total number of AEs reported across all participants	From enrollment to the end of treatment at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leicester Cough Questionnaire	The Leicester Cough Questionnaire is a 19-item questionnaire that measures how chronic cough affects quality of life over the past two weeks. It includes three domains: physical, psychological, and social. Each item is rated on a seven-point Likert scale ranging from "all of the time" to "none of the time." Total score range is between 3-21, with lower scores indicating a worse outcome. Expected means of cough-related quality of life at baseline and follow-up assessments, mean score differences between baseline and follow-up assessments, and expected standard deviations	From enrollment to the end of treatment at 4 weeks
Acceptance and Action Questionnaire-II	The Acceptance and Action Questionnaire-II is a 7-item questionnaire that measures psychological flexibility by assessing the ability to be present and accept internal feelings and thoughts. Each item is rated on a seven-point Likert scale ranging from "never true" to "always true." Total score range is between 7-49, with higher scores indicating a worse outcome. Expected means of psychological flexibility at baseline and follow-up assessments, mean score differences between baseline and follow-up assessments, and expected standard deviations	From enrollment to the end of treatment at 4 weeks
Brief Experiential Avoidance Questionnaire	The Brief Experiential Avoidance Questionnaire is a 15-item questionnaire that measures experiential avoidance by assessing the tendency to avoid unpleasant feelings, thoughts, and bodily sensations. Each item is rated on a six-point Likert scale ranging from "strongly disagree" to "strongly agree." Total score range is between 15-90, with higher scores indicating a worse outcome. Expected means of experiential avoidance at baseline and follow-up assessments, mean score differences between baseline and follow-up assessments, and expected standard deviations	From enrollment to the end of treatment at 4 weeks
Cognitive and Affective Mindfulness Scale-Revised	The Cognitive and Affective Mindfulness Scale-Revised is a 12-item questionnaire that measures a broad concept of mindfulness. Each item is rated on a four-point Likert scale ranging from "rarely/not at all" to "almost always." Total score range is between 12-48, with lower scores indicating a worse outcome. Expected means of mindfulness at baseline and follow-up assessments, mean score differences between baseline and follow-up assessments, and expected standard deviations	From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Carolyn Novaleski, Ph.D., CCC-SLP, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: cough; chronic cough; cough hypersensitivity syndrome
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Cough; Cough; cough hypersensitivity syndrome; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Acceptance and Commitment Therapy
• Other Study ID Numbers: 25-1846; K23HL169934 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) will include demographic and clinical characteristics extracted from the electronic medical records. Primary outcome measures (e.g., feasibility, acceptability) and secondary outcome measures (e.g., cough-related quality of life, psychological flexibility) will be shared. All data will be de-identified prior to sharing, with removal of direct identifiers and use of coded study IDs.
• IPD Sharing Time Frame: De-identified individual participant data (IPD) and supporting information will be made available to the scientific community no later than the time of publication or by the end of the project period, whichever comes first. Data will be preserved for at least five years following the end of the grant award funding period (06/30/2029).
• IPD Sharing Access Criteria: Access to de-identified individual participant data (IPD) and supporting information will be provided to qualified investigators who initiate requests for access. Investigators who submit a reasonable request demonstrating scientific merit, feasibility, and ethical use of the data will be eligible for access. Data will be accessible through a controlled-access process via the UNC Dataverse repository. Interested researchers must submit a request that will be reviewed by the study team. Upon approval, users will be required to complete a Data Use Agreement outlining conditions for data security, confidentiality, and appropriate use. Approved users will be granted access to de-identified datasets and accompanying documentation necessary to interpret and reuse the data.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No