Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome

NCT ID: NCT04170686

Last Updated: 2021-02-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-28

Study Completion Date

2020-09-28

Brief Summary

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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.

Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Waitlist Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Immediate Treatment

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

Group Type EXPERIMENTAL

Zemedy App for Irritable Bowel Syndrome

Intervention Type BEHAVIORAL

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.

Interventions

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Zemedy App for Irritable Bowel Syndrome

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bold Health Inc.

INDUSTRY

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Melissa Hunt, PhD

Associate Director of Clinical Training

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melissa G Hunt, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33872182 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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833848

Identifier Type: -

Identifier Source: org_study_id

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