Single-arm Pilot Trial of Web-based Cognitive Behavioral Therapy for Insomnia (CBTI) in Gastroesophageal Reflux Disease (GERD) Patients With Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Reflux Symptom Questionnaire-7-day recall (RESQ-7)
研究概览
简要总结
This study will enroll patients with persistent reflux symptoms despite proton-pump inhibitor therapy and chronic insomnia. Participants that are eligible for the study and agree to participate will receive cognitive behavioral therapy for insomnia (CBTI) delivered by a web-based approach. The goal of the treatment is to improve the participants insomnia and reflux symptoms. In addition to the cognitive behavioral therapy, participants will be asked to keep a daily diary and periodically complete questionnaires to assess their symptoms.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with persistent reflux symptoms (GERDQ >8) despite proton-pump inhibitor (PPI) therapy.
- •Patients screened positive for chronic insomnia (insomnia severity index [ISI] ≥15).
排除标准
- •Patients with major esophageal motility disorder, prior foregut surgeries, severe cardiopulmonary diseases, or major psychological comorbidities.
- •Patients who report being in "poor" or "very poor" physical or mental health.
- •Patients with sleep apnea (based on STOP-BANG questionnaire >4)
- •Patients with AUDIT score >15, indicating alcohol dependence
- •Patients regularly taking medications for sleep >2 times per week who cannot stop the sleep aid at least 4 weeks prior to and during the study trial.
- •Patients who have previously undergone CBT for insomnia (in person or online).
研究组 & 干预措施
Web-based CBTI
Participants will have 8 weeks to receive 6 therapy sessions. Content is dynamically driven by an animated therapist who guides the user through the program.
干预措施: Web-based CBTI (Behavioral)
结局指标
主要结局
Reflux Symptom Questionnaire-7-day recall (RESQ-7)
时间窗: up to 8 weeks post treatment
RESQ-7 contains 13 items which are aggregated to 4 frequency and 4 intensity domain scores: heartburn (5 items), regurgitation (4 items), cough, hoarseness, difficulty swallowing (3 items), burping (1 item). Frequency questions are scored from 0-7 and intensity questions are scored from 0-5. The range of scores are 0-156 (0 meaning no symptoms, 156 being the worst).
Gastroesophageal Reflux Disease Quality of Life (GERD-QoL)
时间窗: up to 8 weeks post treatment
The questionnaire is composed of 6 items, 4 of which assess symptoms and situations considered positive predictors for GERD diagnosis: heartburn, regurgitations, disorders related to sleep and use of over the counter products. Other 2 items assess 2 nausea and epigastric pain. Participants answer each question about symptoms frequency during last week using a Likert like scale from 0 to 3 for positive predictors and from 3 to 0 for negative predictors. The maximum score that can be obtained is 18.
次要结局
- Insomnia severity index (ISI)(up to 8 weeks post treatment)
- Sleep Onset Latency (SOL)(up to 8 weeks post treatment)
- Wake After Sleep Onset (WASO)(up to 8 weeks post treatment)
研究者
Joan Chen
Clinical Assistant Professor of Internal Medicine
University of Michigan