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

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Immediate Treatment - Zemedy App	Zemedy App	Participants will be given immediate access to the Zemedy app for IBS.
Active Control - Education and Relaxation Training App	Zemedy App	Participants will be given access to a education and relaxation training app. After 8 weeks they will then be crossed over to the Zemedy app.

Primary Outcome Measures

Name	Time	Method
Irritable Bowel Syndrome Quality of Life (IBSQoL)	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)	8 weeks	Gastrointestinal Symptom Rating Scale. Scale scores range from 0-78 with high scores representing worse GI symptoms.

Secondary Outcome Measures

Name	Time	Method
Beck Depression Inventory (BDI)	8 weeks	Measures depressive symptoms. Scale scores range from 0 to 63 with higher scores representing more severe depressive symptoms.
GI-Cognitions Questionnaire (GICog)	8 weeks	Scale measures distorted, catastrophic beliefs about the social and occupational implications of having gastrointestinal symptoms. Scale scores range from 0 to 64 with higher scores representing worse outcomes (more distorted, catastrophic beliefs about GI symptoms)
Visceral Sensitivity Index (VSI)	8 weeks	Scale measures anxiety about visceral (gut) sensations. Scale scores range from 0 to 75 with higher scores representing more anxiety.
Fear of Food Questionnaire (FFQ)	8 weeks	Scale measures fear of food and aversive consequences of eating. Scale scores range from 0-90 with higher scores representing more fear and impairment.
Work Productivity and Activity Impairment (WPAI)	8 weeks	Measures occupational impairment stemming from a health condition. scores range from 0 to 30 with higher scores representing more impairment

Locations (1): University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States