Mobile Self-Management of Irritable Bowel Syndrome for Adolescents

NCT ID: NCT03138980

Last Updated: 2017-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-30

Study Completion Date

2016-09-22

Brief Summary

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The objective of the proposed research is to conduct user testing of a mobile-based self-management support intervention for adolescents and young adults with Irritable Bowel Syndrome (IBS), a chronic digestive condition. The application (app; BodiMojo Buddy) uses a virtual coach that can serve to increase patient engagement through interactive skill-building, self-care, and mindfulness-based cognitive behavioral activities. If the BodiMojo Buddy mobile app is successful, it will have a significant public health impact by providing a mobile resource to the 10-15% of the US population who suffer from IBS and potentially improving health outcomes and reducing significant costs to the US healthcare system.

Study participation involves participants downloading and using the app for 30 days. During the 30 days, participants will interact with the app by inputting their current mood, receiving supportive feedback from the app, reading messages, and doing brief activities (such as relaxation activities, etc.). Before and after the 30 days of user testing, participants will complete a few brief questionnaires about their behavior, how their symptoms affect their life, and how they receive support from others. These questions will take around 20 minutes to complete at each administration.

Detailed Description

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Conditions

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Irritable Bowel Syndrome Abdominal Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Mobile application

Group Type EXPERIMENTAL

BodiMojo Buddy for IBS

Intervention Type BEHAVIORAL

Mobile application focusing on emotional coping skills for teens and young adults with IBS. Components of the module include: mood recorder and "mood cloud," with supportive feedback given based on mood choice; health behavior change support messages informed by mindfulness and self-compassion; quizzes with tailored feedback; library of meditations; an interactive coping skills advice section; and a link to an optional social support feature.

Interventions

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BodiMojo Buddy for IBS

Mobile application focusing on emotional coping skills for teens and young adults with IBS. Components of the module include: mood recorder and "mood cloud," with supportive feedback given based on mood choice; health behavior change support messages informed by mindfulness and self-compassion; quizzes with tailored feedback; library of meditations; an interactive coping skills advice section; and a link to an optional social support feature.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Age 13-21 years
2. For adolescents: Parent-reported physician diagnosis of IBS, using pediatric Rome III diagnostic criteria for functional gastrointestinal disorders. For young adults: self-reported physician diagnosis of IBS using Rome III diagnostic criteria, or meeting criteria for IBS or functional abdominal pain as determined during phone screening.
3. Have daily use of an iPhone or iPad that meets the following technical specifications: at least iOS 8; for iPhones, must be iPhone 5 or above.
4. Able and willing to give informed assent/consent and comply with study requirements
5. Have one caregiver willing and able to participate in the study \[only for 13-17 year olds\]

Exclusion Criteria

1. Inability to provide informed assent/permission/consent
2. Inability to read, speak, and understand English (because the app content/parent guides are written in English, as are the measures being used in the study)
Minimum Eligible Age

13 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BodiMojo, Inc.

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Lonnie Zeltzer

Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UCLA Pediatric Pain Program Research Offices

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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15-001825

Identifier Type: -

Identifier Source: org_study_id

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