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临床试验/NCT04665271
NCT04665271已完成不适用

Acceptability and Efficacy of Zemedy App Versus Education and Relaxation Training App for IBS

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 453 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
453
试验地点
2
主要终点
Irritable Bowel Syndrome Quality of Life (IBSQoL)

研究概览

简要总结

The purpose of this research is to assess if a new digital app version of a self-help intervention for Irritable Bowel Syndrome (IBS), is an acceptable and effective treatment for improving the overall quality of life in patients with IBS.

详细描述

The aim of the current study is to test the acceptability and efficacy of an updated digital app for IBS patients. The design of the study is experimental. There will be two experimental groups, an immediate treatment group and an active control group. Once consented and enrolled, participants will be randomly assigned to either the immediate treatment group or the active control group by the coin toss feature of random.org. Participants in the immediate treatment group will be able to download the app at no cost. Participants in the control group will be given access to an education and relaxation training control app at no cost to them. At 8 weeks after enrollment, all participants in both groups will receive a battery of follow-up questionnaires (the same that they answered directly after consenting in the beginning of the study as baseline measures). Upon receipt of the 8 week questionnaire data, participants in the control group will be given access to the Zemedy app. After having had access to the app for 8 weeks, control participants will be asked to complete another set of questionnaires. All participants will receive 3 month post-treatment follow-up questionnaires. The research method is experimental, cross over (randomized controlled trial) with a control control. Participation in the study will last approximately 4.5 months, depending on the subjects willingness to participate and rate of completion.

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

入选标准

  • Self-report of physician diagnosis of IBS.
  • At least 18 years of age.

排除标准

  • Severe depression or suicidality
  • Comorbid GI disorder such as inflammatory bowel disease or celiac disease.
  • Pregnancy

结局指标

主要结局

Irritable Bowel Syndrome Quality of Life (IBSQoL)

时间窗: 8 weeks

IBS specific health related quality of life measure. Scale scores range from 0-100 with higher scores reflecting more impairment (worse outcome)

Gastrointestinal Symptom Rating Scale (GSRS)

时间窗: 8 weeks

Gastrointestinal Symptom Rating Scale. Scale scores range from 0-78 with high scores representing worse GI symptoms.

次要结局

  • Beck Depression Inventory (BDI)(8 weeks)
  • GI-Cognitions Questionnaire (GICog)(8 weeks)
  • Visceral Sensitivity Index (VSI)(8 weeks)
  • Fear of Food Questionnaire (FFQ)(8 weeks)
  • Work Productivity and Activity Impairment (WPAI)(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Melissa Hunt, PhD

Associate Director of Clinical Training

University of Pennsylvania

研究点 (2)

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