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

Official title

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

Overview

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.

Interventions

• 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

Primary outcome measures

• Recruitment rate [Time frame: From screening and recruitment to enrollment]
• Retention rate [Time frame: From enrollment to the end of treatment at 4 weeks]
• Adherence rate of session attendance [Time frame: From enrollment to the end of treatment at 4 weeks]
• Ordinal scale of adherence to self-directed activities [Time frame: From enrollment to the end of treatment at 4 weeks]
• Likert scale of agreement for cough-related adherence barriers [Time frame: From enrollment to the end of treatment at 4 weeks]
• Likert scale of agreement for acceptability [Time frame: From enrollment to the end of treatment at 4 weeks]
• Likert scale of agreement for appropriateness [Time frame: From enrollment to the end of treatment at 4 weeks]
• Likert scale of agreement for burden [Time frame: From enrollment to the end of treatment at 4 weeks]
• Distress Questionnaire-5 (DQ5) [Time frame: From enrollment to the end of treatment at 4 weeks]
• Binary scale for monitoring program-specific psychological distress [Time frame: From enrollment to the end of treatment at 4 weeks]

Secondary outcome measures (4)

• Leicester Cough Questionnaire [Time frame: From enrollment to the end of treatment at 4 weeks]
• Acceptance and Action Questionnaire-II [Time frame: From enrollment to the end of treatment at 4 weeks]
• Brief Experiential Avoidance Questionnaire [Time frame: From enrollment to the end of treatment at 4 weeks]
• Cognitive and Affective Mindfulness Scale-Revised [Time frame: From enrollment to the end of treatment at 4 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of North Carolina at Chapel Hill — Chapel Hill

Identifiers

NCT: NCT07566117 · 25-1846 · K23HL169934

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗