Skip to main content
OpenTrials
Completed

NCT Number: NCT03138980

Mobile Self-Management of Irritable Bowel Syndrome for Adolescents

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Irritable Bowel Syndrome Abdominal Pain Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

13 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Pediatric Pain Program Research Offices

Los Angeles, California, 90064, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 13-21 years
  • 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.
  • 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.
  • Able and willing to give informed assent/consent and comply with study requirements
  • Have one caregiver willing and able to participate in the study [only for 13-17 year olds]

Exclusion criteria

  • Inability to provide informed assent/permission/consent
  • 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)

Treatment and study plan

BodiMojo Buddy for IBS

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.

Primary outcomes

  1. Ratio of the days during the 30-day intervention period during which participants use the app

    Time frame: 30 days (from day 1 through day 30 of the 30-day intervention period)

    Determined by how often adolescents engaged and used certain features. To be considered feasible, teens must have opened the app on at least two-thirds of the days.

  2. Acceptance

    Time frame: Within 7 days of competing the intervention

    Determined by participants' responses to acceptance test questions in the following domains: (1) perceived connectedness with the Buddy; (2) relevance of the self-management skill building content; and (3) usefulness of self-management skill-building content for IBS. Responses will be given on a one to seven-point-scale ranging "terrible" to "excellent." The intervention will be deemed acceptable if at least 80% of participants rate each question an average of at least "5" ("good") on the 7-point scale.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • BodiMojo, Inc.

Registry information

Official study title

Mobile Self-Management of Irritable Bowel Syndrome for Adolescents: Pilot Study

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 3, 2017
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.