Feasibility, Acceptability, and Safety Trial of Brief, Breath Control-Focused Acceptance and Commitment Therapy in Adults With Chronic Cough (FAST-COUGH)
4 мая 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Оцененный)
30
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Carolyn K. Novaleski, Ph.D., CCC-SLP
- Номер телефона: 919-962-5965
- Электронная почта: carolyn_novaleski@med.unc.edu
Места учебы
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North Carolina
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Chapel Hill, North Carolina, Соединенные Штаты, 27599
- University of North Carolina at Chapel Hill
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Контакт:
- Carolyn K. Novaleski, Ph.D., CCC-SLP
- Номер телефона: 919-962-5965
- Электронная почта: carolyn_novaleski@med.unc.edu
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-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Recruitment rate
Временное ограничение: From screening and recruitment to enrollment
|
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
Временное ограничение: From enrollment to the end of treatment at 4 weeks
|
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
Временное ограничение: From enrollment to the end of treatment at 4 weeks
|
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
Временное ограничение: 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
Временное ограничение: From enrollment to the end of treatment at 4 weeks
|
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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: From enrollment to the end of treatment at 4 weeks
|
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)
Временное ограничение: From enrollment to the end of treatment at 4 weeks
|
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
Временное ограничение: From enrollment to the end of treatment at 4 weeks
|
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)
Временное ограничение: From enrollment to the end of treatment at 4 weeks
|
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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Leicester Cough Questionnaire
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: From enrollment to the end of treatment at 4 weeks
|
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
Временное ограничение: From enrollment to the end of treatment at 4 weeks
|
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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Carolyn Novaleski, Ph.D., CCC-SLP, University of North Carolina, Chapel Hill
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 августа 2026 г.
Первичное завершение (Оцененный)
30 июня 2029 г.
Завершение исследования (Оцененный)
30 июня 2029 г.
Даты регистрации исследования
Первый отправленный
28 апреля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
28 апреля 2026 г.
Первый опубликованный (Действительный)
4 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
6 мая 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
4 мая 2026 г.
Последняя проверка
1 апреля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Заболевания дыхательных путей
- Нарушения дыхания
- Признаки и симптомы, Респираторные
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Хронический кашель
- Кашель
- Синдром гиперчувствительности кашля
- Поведенческая терапия
- Психотерапия
- Поведенческие дисциплины и деятельность
- Когнитивная поведенческая терапия
- Терапия принятия и обязательства
Другие идентификационные номера исследования
- 25-1846
- K23HL169934 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
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.
Сроки обмена IPD
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).
Критерии совместного доступа к IPD
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.
Совместное использование IPD Поддерживающий тип информации
- АНАЛИТИЧЕСКИЙ_КОД
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .