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.
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
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
Single group
Acceptance and Commitment Therapy (ACT)
BehavioralBrief 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
Recruitment rate
Proportion of participants in the target population expected to enroll in the study (numerator) out of all eligible individuals identified (denominator)
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)
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)
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)
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
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
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
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
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University of North Carolina, Chapel Hill
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
