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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Recruitment rate
Proportion of participants in the target population expected to enroll in the study (numerator) out of all eligible individuals identified (denominator)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: From enrollment to the end of treatment at 4 weeks
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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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From enrollment to the end of treatment at 4 weeks
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From enrollment to the end of treatment at 4 weeks