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

Browse trials for

• Chronic Cough 142
• Cough 427

Keywords

• chronic cough
• cough
• cough hypersensitivity syndrome

Chronic Cough

142 studies on the registry are indexed under Chronic Cough; 39 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 104 interventional studies indexed under Chronic Cough.

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.

Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.

Study arms

• Experimental
  Acceptance and Commitment Therapy (ACT)

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

  Behavioral: Acceptance and Commitment Therapy (ACT)

Interventions

• BehavioralAcceptance 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 outcomes

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

Secondary outcomes

1. 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

2. 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

3. 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

4. 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

Individual participant data

Plan to share: Yes — De-identified individual participant data (IPD) will include demographic and clinical characteristics extracted from the electronic medical records. Primary outcome measures (e.g., feasibility, acceptability) and secondary outcome measures (e.g., cough-related quality of life, psychological flexibility) will be shared. All data will be de-identified prior to sharing, with removal of direct identifiers and use of coded study IDs.

Supporting information: 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.