NCT04170686

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2019

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2020

Completed
3 months until next milestone

Results Posted

Study results publicly available

December 24, 2020

Completed
Last Updated

February 16, 2021

Status Verified

January 1, 2021

Enrollment Period

11 months

First QC Date

November 14, 2019

Results QC Date

October 26, 2020

Last Update Submit

January 28, 2021

Conditions

Irritable Bowel Syndrome

Keywords

cognitive behavioral therapyself-helpirritable bowel syndrome

Outcome Measures

Primary Outcomes (2)

  • Irritable Bowel Syndrome Quality of Life

    A self-report measure of health related quality of life (HRQL) in people with irritable bowel syndrome. Scores range from 0 to 100. Higher scores are a worse outcome.

    8 weeks

  • Gastrointestinal Symptom Rating Scale

    a self-report measure of GI symptom severity. Scores range from 0 to 78. Higher scores are a worse outcome.

    8 weeks

Secondary Outcomes (7)

  • Visceral Sensitivity Index

    8 weeks

  • GI Cognitions Questionnaire

    8 weeks

  • Fear of Food Questionnaire

    8 weeks

  • Patient Health Questionnaire

    8 weeks

  • Depression Anxiety and Stress Scale - Depression Subscale

    8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Immediate Treatment

EXPERIMENTAL

Participants will have immediate access to the self-help app. They will take 8 weeks to work through the content at their own pace.

Behavioral: Zemedy App for Irritable Bowel Syndrome

Waitlist Control

NO INTERVENTION

Participants in the waitlist will receive no intervention for 8 weeks, other than a few "check in" emails from study personnel. At the end of 8 weeks, they will be crossed over to the active treatment group and will be given access to the app.

Interventions

Zemedy App for Irritable Bowel SyndromeBEHAVIORAL

The Zemedy App for irritable bowel syndrome is designed to be an engaging, self-help app for people with irritable bowel syndrome. It is based on empirically supported cognitive-behavioral, and GI focused hypnotherapy interventions for IBS.

Immediate Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of IBS. Own a smart phone. Speak English

You may not qualify if:

  • Under age of consent (18) Diagnosed with another GI disorder (e.g. celiac disease, inflammatory bowel disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-6018, United States

Location

Related Publications (1)

  • Hunt M, Miguez S, Dukas B, Onwude O, White S. Efficacy of Zemedy, a Mobile Digital Therapeutic for the Self-management of Irritable Bowel Syndrome: Crossover Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 May 20;9(5):e26152. doi: 10.2196/26152.

    PMID: 33872182DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Limitations and Caveats

As is the case with most internet trials we experienced significant attrition from both arms. In the final publication, multiple imputation will be used to account for missing data and both treatment completer and intent-to-treat results will be reported.

Results Point of Contact

Title
Dr. Melissa G. Hunt
Organization
University of Pennsylvania
mhunt@psych.upenn.edu
610-529-8055

Study Officials

  • Melissa G Hunt, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

Study Record Dates

First Submitted

November 14, 2019

First Posted

November 20, 2019

Study Start

October 28, 2019

Primary Completion

September 28, 2020

Study Completion

September 28, 2020

Last Updated

February 16, 2021

Results First Posted

December 24, 2020

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)