RxWell in Pediatric IBD for Disease Management and Transition Readiness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-30

Study Completion Date

2023-03-08

Brief Summary

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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.

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Detailed Description

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Baseline TRAQ and PHQ-4 scores will be obtained from the patient as part of routine care during annual visits or as a screening tool after consent to determine eligibility. If the patient is recruited from a visit other than the annual visit, the TRAQ and PHQ4 will be completed to determine eligibility after consent. If eligible, the participant will complete the IBD self-efficacy scale, GAD7, and PHQ8, and will be provided with an access code to download RxWell and will be paired with a UPMC digital health coach who will guide the person through the sessions and text within the app to help give them the tools needed to actively cope with anxiety and/or depression. The adapted version of RxWell includes the same RxWell content/techniques but the coaching model within the adapted version has increased responsibilities of the coach, encouraging the development of necessary transition knowledge and skills for the patient. Coaches in this version will also participate in training about how best to interact with IBD patients regarding their chronic illness, transitions to adult physician, and care management. These coaches will be supervised by a licensed UPMC mental health clinician. The coaches will be informed of the reason for each user's access to the dCBI, TRAQ or PHQ score or both and will interact with the user accordingly. Participants will be asked to complete all study measures (TRAQ, PHQ8, IBD Self-Efficacy, and GAD7) at all time points, baseline, 3 and 6 months.

The user will have access to the app and coach for six months after they have consented. Each technique that is used during those six months will be stored in the practice-again section and available to the participant for use during the study. After six months, participants will no longer have access to the app and will be informed about this change. Participants are informed when they sign up for this app that is not a crisis management tool. There is a risk escalation protocol in place at UPMC if the content of patient's messaging to coaches is alarming.

A randomly selected group of patients who consent to this study and engage with the app, meaning completing 3 or more techniques and/ or actively engaged with the coach, will participate in qualitative interviews to determine how to best implement disease self-management tools within the digital behavioral tool. Every third participant who consents and meets the engagement criteria will be contacted to complete the qualitative interview.

All participants will also be asked to complete quantitative assessments at baseline and again 3 and 6 months later.

Conditions

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Mental Health Issue Inflammatory Bowel Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Digital Cognitive Behavioral Intervention (DCBI)

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.

Group Type EXPERIMENTAL

dCBI

Intervention Type 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.

Interventions

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dCBI

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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