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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL169934 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Experimental | Brief Acceptance and Commitment Therapy (ACT) combined with breath control techniques |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolyn K. Novaleski, Ph.D., CCC-SLP | Contact | 919-962-5965 | carolyn_novaleski@med.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Carolyn Novaleski, Ph.D., CCC-SLP | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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.
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 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.
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| 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 |
| 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 | 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 | 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 | From enrollment to the end of treatment at 4 weeks |
| ID | Term |
|---|---|
| D000096822 | Chronic Cough |
| D003371 | Cough |
| C000726768 | cough hypersensitivity syndrome |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D064869 | Acceptance and Commitment Therapy |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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