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

University of Pennsylvania

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Behavioral: Zemedy App

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04665271

844160

Details and patient eligibility

About

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.

Full 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.

Enrollment: 453 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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453 participants in 2 patient groups

Immediate Treatment - Zemedy App

Experimental group

Description:

Participants will be given immediate access to the Zemedy app for IBS.

Treatment:

Behavioral: Zemedy App

Active Control - Education and Relaxation Training App

Active Comparator group

Description:

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.

Treatment:

Behavioral: Zemedy App