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NCT Number: NCT07566117

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

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.

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Key information

Conditions

Chronic Cough Cough Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory cough hypersensitivity syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location contact

Carolyn K. Novaleski, Ph.D., CCC-SLP

CONTACT

[email protected]

919-962-5965

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Acceptance and Commitment Therapy (ACT)

Behavioral

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

Primary outcomes

  1. Recruitment rate

    Time frame: From screening and recruitment to enrollment

    Proportion of participants in the target population expected to enroll in the study (numerator) out of all eligible individuals identified (denominator)

  2. Retention rate

    Time frame: From enrollment to the end of treatment at 4 weeks

    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)

  3. Adherence rate of session attendance

    Time frame: From enrollment to the end of treatment at 4 weeks

    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)

  4. Ordinal scale of adherence to self-directed activities

    Time frame: From enrollment to the end of treatment at 4 weeks

    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)

  5. Likert scale of agreement for cough-related adherence barriers

    Time frame: From enrollment to the end of treatment at 4 weeks

    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

  6. Likert scale of agreement for acceptability

    Time frame: From enrollment to the end of treatment at 4 weeks

    Proportion of participants enrolled in the study who completed the follow-up assessments expected to strongly agree or agree that the program was acceptable

  7. Likert scale of agreement for appropriateness

    Time frame: From enrollment to the end of treatment at 4 weeks

    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

  8. Likert scale of agreement for burden

    Time frame: From enrollment to the end of treatment at 4 weeks

    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

  9. Distress Questionnaire-5 (DQ5)

    Time frame: From enrollment to the end of treatment at 4 weeks

    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

  10. Binary scale for monitoring program-specific psychological distress

    Time frame: From enrollment to the end of treatment at 4 weeks

    Proportion of participants enrolled in the study expected to report experiencing increased psychological distress specifically related to the program

  11. Adverse events (AEs)

    Time frame: From enrollment to the end of treatment at 4 weeks

    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

Secondary outcomes

  1. Leicester Cough Questionnaire

    Time frame: From enrollment to the end of treatment at 4 weeks

    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

  2. Acceptance and Action Questionnaire-II

    Time frame: From enrollment to the end of treatment at 4 weeks

    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

  3. Brief Experiential Avoidance Questionnaire

    Time frame: From enrollment to the end of treatment at 4 weeks

    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

  4. Cognitive and Affective Mindfulness Scale-Revised

    Time frame: From enrollment to the end of treatment at 4 weeks

    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

Study contacts

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

Carolyn K. Novaleski, Ph.D., CCC-SLP

CONTACT

[email protected]

919-962-5965

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: FAST-COUGH

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 4, 2026
Registry last updated
May 6, 2026

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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