Mobile Self-Management of Irritable Bowel Syndrome for Adolescents

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

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome; Abdominal Pain
• Intervention / Treatment: Behavioral: BodiMojo Buddy for IBS

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90064
      • UCLA Pediatric Pain Program Research Offices

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mobile application

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of the days during the 30-day intervention period during which participants use the app	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.	30 days (from day 1 through day 30 of the 30-day intervention period)
Acceptance	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.	Within 7 days of competing the intervention

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: BodiMojo, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2016
• Primary Completion (Actual): September 22, 2016
• Study Completion (Actual): September 22, 2016

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): June 27, 2017
• Last Update Submitted That Met QC Criteria: June 26, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Pain; Neurologic Manifestations; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Abdominal Pain
• Other Study ID Numbers: 15-001825

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No