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

NCT04665271 | Completed

• 1 other identifier: 844160
• Study Type: interventional
• Target: 453
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

cognitive behavioral therapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• GI-Cognitions Questionnaire (GICog)

  8 weeks

• Visceral Sensitivity Index (VSI)

  8 weeks

• Fear of Food Questionnaire (FFQ)

  8 weeks

• Beck Depression Inventory (BDI)

  8 weeks

• Work Productivity and Activity Impairment (WPAI)

  8 weeks

Study Arms (2)

Immediate Treatment - Zemedy App

EXPERIMENTAL

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

Behavioral: Zemedy App

Active Control - Education and Relaxation Training App

ACTIVE COMPARATOR

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.

Behavioral: Zemedy App

Interventions

Zemedy App BEHAVIORAL

Digital smart phone app that delivers cognitive-behavioral therapy for IBS

Active Control - Education and Relaxation Training App; Immediate Treatment - Zemedy App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Bold Health Inc.: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-6018, United States

Location

Related Publications (1)

• Hunt MG, Dalvie A, Ipek S, Wasman B. Acceptability and efficacy of the Zemedy app versus a relaxation training and meditation app for IBS: protocol for a randomised controlled trial. BMJ Open. 2022 Jan 17;12(1):e055014. doi: 10.1136/bmjopen-2021-055014.

  PMID: 35039299 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Clinical Training

Model Details: Active control with cross-over at post-treatment and three month follow-up

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: December 11, 2020
• Study Start: March 1, 2021
• Primary Completion: December 30, 2023
• Study Completion: May 28, 2024
• Last Updated: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)