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RxWell in Pediatric IBD for Disease Management and Transition Readiness

Primary Purpose

Mental Health Issue, Inflammatory Bowel Diseases

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dCBI
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Health Issue focused on measuring mobile app, digital behavioral tool, adolescent and young adult

Eligibility Criteria

16 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Exclusion Criteria:

  • Developmental delay

Sites / Locations

  • Children's Hospital of Pittsburgh

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Digital Cognitive Behavioral Intervention (DCBI)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change in Transition Readiness to Adult Care
Change in transition readiness assessment questionnaire that measures the readiness of a patient to care for their own medical needs without parental/guardian support (score ranges from 20-100 where the higher score demonstrates higher competency in caring for one's own needs) is completed at baseline, 3 and 6 months. This measure will be studied over time, up to 6 months.

Full Information

First Posted
July 12, 2022
Last Updated
June 8, 2023
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT05461014
Brief Title
RxWell in Pediatric IBD for Disease Management and Transition Readiness
Official Title
Evaluating the Acceptability, Feasibility Utilization of a Digital Behavioral Tool for Adolescents and Young Adults With IBD Who Are in the Process of Transitioning From Pediatric to Adult Care
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
PI left the institution
Study Start Date
July 30, 2022 (Actual)
Primary Completion Date
March 8, 2023 (Actual)
Study Completion Date
March 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Issue, Inflammatory Bowel Diseases
Keywords
mobile app, digital behavioral tool, adolescent and young adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Digital Cognitive Behavioral Intervention (DCBI)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
dCBI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in anxiety severity over time
Description
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.
Time Frame
6 months
Title
Change in depression severity
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in Transition Readiness to Adult Care
Description
Change in transition readiness assessment questionnaire that measures the readiness of a patient to care for their own medical needs without parental/guardian support (score ranges from 20-100 where the higher score demonstrates higher competency in caring for one's own needs) is completed at baseline, 3 and 6 months. This measure will be studied over time, up to 6 months.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Exclusion Criteria: Developmental delay
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Kim, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual patient data will not be shared. Data will be shared at the aggregate level.

Learn more about this trial

RxWell in Pediatric IBD for Disease Management and Transition Readiness

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