Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Irritable Bowel Syndrome Quality of Life
研究概览
简要总结
The purpose of this research is to assess if a new self-help app for IBS is an acceptable and effective intervention for improving the overall quality of life in patients with Irritable Bowel Syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Diagnosis of IBS. Own a smart phone. Speak English
排除标准
- •Under age of consent (18) Diagnosed with another GI disorder (e.g. celiac disease, inflammatory bowel disease)
研究组 & 干预措施
Immediate Treatment
Participants will have immediate access to the self-help app. They will take 8 weeks to work through the content at their own pace.
干预措施: Zemedy App for Irritable Bowel Syndrome (Behavioral)
Waitlist Control
Participants in the waitlist will receive no intervention for 8 weeks, other than a few "check in" emails from study personnel. At the end of 8 weeks, they will be crossed over to the active treatment group and will be given access to the app.
结局指标
主要结局
Irritable Bowel Syndrome Quality of Life
时间窗: 8 weeks
A self-report measure of health related quality of life (HRQL) in people with irritable bowel syndrome. Scores range from 0 to 100. Higher scores are a worse outcome.
Gastrointestinal Symptom Rating Scale
时间窗: 8 weeks
a self-report measure of GI symptom severity. Scores range from 0 to 78. Higher scores are a worse outcome.
次要结局
- Visceral Sensitivity Index(8 weeks)
- Fear of Food Questionnaire(8 weeks)
- Depression Anxiety and Stress Scale - Anxiety Subscale(8 weeks)
- GI Cognitions Questionnaire(8 weeks)
- Patient Health Questionnaire(8 weeks)
- Depression Anxiety and Stress Scale - Depression Subscale(8 weeks)
- Depression Anxiety and Stress Scale - Stress Subscale(8 weeks)
研究者
Melissa Hunt, PhD
Associate Director of Clinical Training
University of Pennsylvania