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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04665271
• Other study ID #: 844160
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: May 28, 2024

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: May 28, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Behavioral:
• Zemedy App
Digital smart phone app that delivers cognitive-behavioral therapy for IBS

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Bold Health Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Irritable Bowel Syndrome Quality of Life (IBSQoL)	IBS specific health related quality of life measure. Scale scores range from 0-100 with higher scores reflecting more impairment (worse outcome)	8 weeks
Primary	Gastrointestinal Symptom Rating Scale (GSRS)	Gastrointestinal Symptom Rating Scale. Scale scores range from 0-78 with high scores representing worse GI symptoms.	8 weeks
Secondary	GI-Cognitions Questionnaire (GICog)	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)	8 weeks
Secondary	Visceral Sensitivity Index (VSI)	Scale measures anxiety about visceral (gut) sensations. Scale scores range from 0 to 75 with higher scores representing more anxiety.	8 weeks
Secondary	Fear of Food Questionnaire (FFQ)	Scale measures fear of food and aversive consequences of eating. Scale scores range from 0-90 with higher scores representing more fear and impairment.	8 weeks
Secondary	Beck Depression Inventory (BDI)	Measures depressive symptoms. Scale scores range from 0 to 63 with higher scores representing more severe depressive symptoms.	8 weeks
Secondary	Work Productivity and Activity Impairment (WPAI)	Measures occupational impairment stemming from a health condition. scores range from 0 to 30 with higher scores representing more impairment	8 weeks