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

NCT07566117 | Not Yet Recruiting

• 2 other identifiers: 25-1846K23HL169934
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Cough

Keywords

chronic cough; cough; cough hypersensitivity syndrome

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (4)

• Leicester Cough Questionnaire

  From enrollment to the end of treatment at 4 weeks

• Acceptance and Action Questionnaire-II

  From enrollment to the end of treatment at 4 weeks

• Brief Experiential Avoidance Questionnaire

  From enrollment to the end of treatment at 4 weeks

• Cognitive and Affective Mindfulness Scale-Revised

  From enrollment to the end of treatment at 4 weeks

Study Arms (1)

Acceptance and Commitment Therapy (ACT)

EXPERIMENTAL

Brief Acceptance and Commitment Therapy (ACT) combined with breath control techniques

Behavioral: Acceptance and Commitment Therapy (ACT)

Interventions

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

Acceptance and Commitment Therapy (ACT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed patient with UNC Health electronic medical record number (MRN) via medical chart review
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Chronic Cough; Cough; cough hypersensitivity syndrome

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Carolyn Novaleski, Ph.D., CCC-SLP

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

919-962-5965; carolyn_novaleski@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• 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).
• 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.

Locations

US (1)