RxWell in Pediatric IBD for Disease Management and Transition Readiness

NCT05461014 | Terminated

• 1 other identifier: STUDY21100037
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the feasibility and acceptability of adapted coached RxWell for patients ages 16-25. Adapt and beta test the modified RxWell product to include chronic disease management and transition readiness. Evaluate RxWell usage and its impact to the TRAQ questionnaire over time.

Conditions

Mental Health Issue; Inflammatory Bowel Diseases

Keywords

mobile app; digital behavioral tool; adolescent and young adult

Outcome Measures

Primary Outcomes (2)

• Change in anxiety severity over time

  Generalized Anxiety Disorder 7 measures anxiety severity (score ranges from 0-21, with 21 being severe anxiety) is completed within the app and at three study timepoints (baseline, 3 months and 6 months). This measure will be studied over time, up to 6 months.

  6 months

• Change in depression severity

  Patient Health Questionnaire 8 to measures depression severity (score ranges from 0-24, with 24 being severe depression) is completed within the app and at three study timepoints (baseline, 3 months and 6 months). This measure will be studied over time, up to 6 months.

  6 months

Secondary Outcomes (1)

• Change in Transition Readiness to Adult Care

  6 months

Study Arms (1)

Digital Cognitive Behavioral Intervention (DCBI)

EXPERIMENTAL

The dCBI, RxWell, is a trans cognitive behavioral therapy (CBT) mobile app product addressing depression and anxiety that was developed based on standard CBT techniques.

Behavioral: dCBI

Interventions

dCBI BEHAVIORAL

The dCBI, RxWell, is a trans-CBT mobile app product addressing depression and anxiety that was developed based on standard CBT techniques. RxWell provides users users with 40 brief (5-10 minute) skill building techniques for anxiety and depression. Users will have access to a goal-setting tab and "in the moment relief" section which contains over 17 techniques,14 of which are brief audios to help users engage relaxation responses. The user will be provided with the depression path, which has 40 unique techniques, and if the user expresses significant anxiety, the coach will have the ability to personalize the program by pulling in any of the 53 techniques from the anxiety path, so that the individual can utilize the proper CBT techniques that fit with their presentation. The coaches are trained to provide assistance with adult care transition readiness.

Digital Cognitive Behavioral Intervention (DCBI)

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Individuals ages 16-25 years with established IBD who are followed in the pediatric gastroenterology clinics at the UPMC Children's Hospital of Pittsburgh
• Patient must be English speaking
• Access to Smartphone
• PHQ-4 score ≥ 5 and/or TRAQ score ≥ 60

You may not qualify if:

• Developmental delay

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Sandra Kim, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 15, 2022
• Study Start: July 30, 2022
• Primary Completion: March 8, 2023
• Study Completion: March 8, 2023
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)