Identifying Predictors of Treatment Response to Pharmacologic and Nonpharmacologic Interventions in Cough Hypersensitivity Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Acceptance and Commitment Therapy (ACT)
Brief Acceptance and Commitment Therapy (ACT) combined with breath control techniques
干预措施: Acceptance and Commitment Therapy (ACT) (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: 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)
Retention rate
时间窗: 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)
Adherence rate of session attendance
时间窗: 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)
Ordinal scale of adherence to self-directed activities
时间窗: 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)
Likert scale of agreement for cough-related adherence barriers
时间窗: 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
Likert scale of agreement for acceptability
时间窗: 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
Likert scale of agreement for appropriateness
时间窗: 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
Likert scale of agreement for burden
时间窗: 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
Distress Questionnaire-5 (DQ5)
时间窗: 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
Binary scale for monitoring program-specific psychological distress
时间窗: 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
Adverse events (AEs)
时间窗: 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
次要结局
- Leicester Cough Questionnaire(From enrollment to the end of treatment at 4 weeks)
- Acceptance and Action Questionnaire-II(From enrollment to the end of treatment at 4 weeks)
- Brief Experiential Avoidance Questionnaire(From enrollment to the end of treatment at 4 weeks)
- Cognitive and Affective Mindfulness Scale-Revised(From enrollment to the end of treatment at 4 weeks)