Feasibility, Acceptability, and Safety Trial of Brief, Breath Control-Focused Acceptance and Commitment Therapy in Adults With Chronic Cough (FAST-COUGH)
2026년 5월 4일 업데이트: University of North Carolina, Chapel Hill
Identifying Predictors of Treatment Response to Pharmacologic and Nonpharmacologic Interventions in Cough Hypersensitivity Syndrome
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.
연구 개요
연구 유형
중재적
등록 (추정된)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Carolyn K. Novaleski, Ph.D., CCC-SLP
- 전화번호: 919-962-5965
- 이메일: carolyn_novaleski@med.unc.edu
연구 장소
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599
- University of North Carolina at Chapel Hill
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연락하다:
- Carolyn K. Novaleski, Ph.D., CCC-SLP
- 전화번호: 919-962-5965
- 이메일: carolyn_novaleski@med.unc.edu
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Acceptance and Commitment Therapy (ACT)
Brief Acceptance and Commitment Therapy (ACT) combined with breath control techniques
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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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Recruitment rate
기간: From screening and recruitment to enrollment
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Proportion of participants in the target population expected to enroll in the study (numerator) out of all eligible individuals identified (denominator)
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From screening and recruitment to enrollment
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Retention rate
기간: From enrollment to the end of treatment at 4 weeks
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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)
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From enrollment to the end of treatment at 4 weeks
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Adherence rate of session attendance
기간: From enrollment to the end of treatment at 4 weeks
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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)
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From enrollment to the end of treatment at 4 weeks
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Ordinal scale of adherence to self-directed activities
기간: From enrollment to the end of treatment at 4 weeks
|
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)
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From enrollment to the end of treatment at 4 weeks
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Likert scale of agreement for cough-related adherence barriers
기간: From enrollment to the end of treatment at 4 weeks
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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
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From enrollment to the end of treatment at 4 weeks
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Likert scale of agreement for acceptability
기간: From enrollment to the end of treatment at 4 weeks
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Proportion of participants enrolled in the study who completed the follow-up assessments expected to strongly agree or agree that the program was acceptable
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From enrollment to the end of treatment at 4 weeks
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Likert scale of agreement for appropriateness
기간: From enrollment to the end of treatment at 4 weeks
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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
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From enrollment to the end of treatment at 4 weeks
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Likert scale of agreement for burden
기간: From enrollment to the end of treatment at 4 weeks
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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
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From enrollment to the end of treatment at 4 weeks
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Distress Questionnaire-5 (DQ5)
기간: From enrollment to the end of treatment at 4 weeks
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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
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From enrollment to the end of treatment at 4 weeks
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Binary scale for monitoring program-specific psychological distress
기간: From enrollment to the end of treatment at 4 weeks
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Proportion of participants enrolled in the study expected to report experiencing increased psychological distress specifically related to the program
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From enrollment to the end of treatment at 4 weeks
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Adverse events (AEs)
기간: From enrollment to the end of treatment at 4 weeks
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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
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From enrollment to the end of treatment at 4 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Leicester Cough Questionnaire
기간: From enrollment to the end of treatment at 4 weeks
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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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From enrollment to the end of treatment at 4 weeks
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Acceptance and Action Questionnaire-II
기간: From enrollment to the end of treatment at 4 weeks
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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
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From enrollment to the end of treatment at 4 weeks
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Brief Experiential Avoidance Questionnaire
기간: From enrollment to the end of treatment at 4 weeks
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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
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From enrollment to the end of treatment at 4 weeks
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Cognitive and Affective Mindfulness Scale-Revised
기간: From enrollment to the end of treatment at 4 weeks
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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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From enrollment to the end of treatment at 4 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Carolyn Novaleski, Ph.D., CCC-SLP, University of North Carolina, Chapel Hill
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 1일
기본 완료 (추정된)
2029년 6월 30일
연구 완료 (추정된)
2029년 6월 30일
연구 등록 날짜
최초 제출
2026년 4월 28일
QC 기준을 충족하는 최초 제출
2026년 4월 28일
처음 게시됨 (실제)
2026년 5월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 4일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 25-1846
- K23HL169934 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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.
IPD 공유 기간
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).
IPD 공유 액세스 기준
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.
IPD 공유 지원 정보 유형
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .