Feasibility, Acceptability, and Safety Trial of Brief, Breath Control-Focused Acceptance and Commitment Therapy in Adults With Chronic Cough (FAST-COUGH)
2026年5月4日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
30
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Carolyn K. Novaleski, Ph.D., CCC-SLP
- 電話番号：919-962-5965
- メール：carolyn_novaleski@med.unc.edu
研究場所
-
-
North Carolina
-
Chapel Hill、North Carolina、アメリカ、27599
- University of North Carolina at Chapel Hill
-
コンタクト：
- Carolyn K. Novaleski, Ph.D., CCC-SLP
- 電話番号：919-962-5965
- メール：carolyn_novaleski@med.unc.edu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Acceptance and Commitment Therapy (ACT)
Brief Acceptance and Commitment Therapy (ACT) combined with breath control techniques
|
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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recruitment rate
時間枠：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)
|
From screening and recruitment to enrollment
|
|
Retention rate
時間枠：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)
|
From enrollment to the end of treatment at 4 weeks
|
|
Adherence rate of session attendance
時間枠：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)
|
From enrollment to the end of treatment at 4 weeks
|
|
Ordinal scale of adherence to self-directed activities
時間枠：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)
|
From enrollment to the end of treatment at 4 weeks
|
|
Likert scale of agreement for cough-related adherence barriers
時間枠：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
|
From enrollment to the end of treatment at 4 weeks
|
|
Likert scale of agreement for acceptability
時間枠：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 program was acceptable
|
From enrollment to the end of treatment at 4 weeks
|
|
Likert scale of agreement for appropriateness
時間枠：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 program was a good fit for people with chronic cough
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From enrollment to the end of treatment at 4 weeks
|
|
Likert scale of agreement for burden
時間枠：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
|
From enrollment to the end of treatment at 4 weeks
|
|
Distress Questionnaire-5 (DQ5)
時間枠：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
|
From enrollment to the end of treatment at 4 weeks
|
|
Binary scale for monitoring program-specific psychological distress
時間枠：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
|
From enrollment to the end of treatment at 4 weeks
|
|
Adverse events (AEs)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Leicester Cough Questionnaire
時間枠：From enrollment to the end of treatment at 4 weeks
|
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
|
From enrollment to the end of treatment at 4 weeks
|
|
Acceptance and Action Questionnaire-II
時間枠：From enrollment to the end of treatment at 4 weeks
|
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
時間枠：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
|
From enrollment to the end of treatment at 4 weeks
|
|
Cognitive and Affective Mindfulness Scale-Revised
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Carolyn Novaleski, Ph.D., CCC-SLP、University of North Carolina, Chapel Hill
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2029年6月30日
研究の完了 (推定)
2029年6月30日
試験登録日
最初に提出
2026年4月28日
QC基準を満たした最初の提出物
2026年4月28日
最初の投稿 (実際)
2026年5月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月6日
QC基準を満たした最後の更新が送信されました
2026年5月4日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 25-1846
- K23HL169934 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
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 共有アクセス基準
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 共有サポート情報タイプ
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。