Mobile Self-Management of Irritable Bowel Syndrome for Adolescents
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|ClinicalTrials.gov Identifier: NCT03138980|
Recruitment Status : Completed
First Posted : May 3, 2017
Last Update Posted : June 27, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome Abdominal Pain||Behavioral: BodiMojo Buddy for IBS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Mobile Self-Management of Irritable Bowel Syndrome for Adolescents: Pilot Study|
|Actual Study Start Date :||January 30, 2016|
|Actual Primary Completion Date :||September 22, 2016|
|Actual Study Completion Date :||September 22, 2016|
|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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138980
|United States, California|
|UCLA Pediatric Pain Program Research Offices|
|Los Angeles, California, United States, 90064|