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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)

4 de maio de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

30

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599
        • University of North Carolina at Chapel Hill
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Acceptance and Commitment Therapy (ACT)
Brief Acceptance and Commitment Therapy (ACT) combined with breath control techniques
Comportamental: 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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Recruitment rate
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Leicester Cough Questionnaire
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of North Carolina, Chapel Hill

Colaboradores

National Heart, Lung, and Blood Institute (NHLBI)

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de agosto de 2026

Conclusão Primária (Estimado)

30 de junho de 2029

Conclusão do estudo (Estimado)

30 de junho de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

28 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de abril de 2026

Primeira postagem (Real)

4 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de maio de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 25-1846
  • K23HL169934 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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.

Prazo de Compartilhamento de 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).

Critérios de acesso de compartilhamento 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.

Tipo de informação de suporte de compartilhamento de IPD

  • ANALYTIC_CODE

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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