Mobile Self-Management of Irritable Bowel Syndrome for Adolescents

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03138980
• Other study ID #: 15-001825
• Status: Completed
• Phase: N/A
• First received: April 28, 2017
• Last updated: June 26, 2017
• Start date: January 30, 2016
• Est. completion date: September 22, 2016

Study information

• Verified date: June 2017
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 22, 2016
• Est. primary completion date: September 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 21 Years

Eligibility

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)

Related Conditions & MeSH terms

• Abdominal Pain
• Irritable Bowel Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	UCLA Pediatric Pain Program Research Offices	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	BodiMojo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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