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

maanantai 4. toukokuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Ei vielä rekrytointia

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

30

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Opiskelupaikat

  • Yhdysvallat
    • North Carolina
      • Chapel Hill, North Carolina, Yhdysvallat, 27599
        • University of North Carolina at Chapel Hill
        • Ottaa yhteyttä:

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Ei käytössä
  • Inventiomalli: Yksittäinen ryhmätehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Acceptance and Commitment Therapy (ACT)
Brief Acceptance and Commitment Therapy (ACT) combined with breath control techniques
Käyttäytyminen: Acceptance 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

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Recruitment rate
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
From enrollment to the end of treatment at 4 weeks
Likert scale of agreement for burden
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Leicester Cough Questionnaire
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

University of North Carolina, Chapel Hill

Yhteistyökumppanit

National Heart, Lung, and Blood Institute (NHLBI)

Tutkijat

  • Päätutkija: Carolyn Novaleski, Ph.D., CCC-SLP, University of North Carolina, Chapel Hill

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Arvioitu)

Lauantai 1. elokuuta 2026

Ensisijainen valmistuminen (Arvioitu)

Lauantai 30. kesäkuuta 2029

Opintojen valmistuminen (Arvioitu)

Lauantai 30. kesäkuuta 2029

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Tiistai 28. huhtikuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 28. huhtikuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Maanantai 4. toukokuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 6. toukokuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 4. toukokuuta 2026

Viimeksi vahvistettu

Keskiviikko 1. huhtikuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 25-1846
  • K23HL169934 (Yhdysvaltain NIH-apuraha/sopimus)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

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-jaon aikakehys

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-jaon käyttöoikeuskriteerit

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-jakamista tukeva tietotyyppi

  • ANALYTIC_CODE

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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