Mental Health IssueNCT05461014
RxWell in Pediatric IBD for Disease Management and Transition Readiness
A study testing dCBI in people with Mental Health Issue and Inflammatory Bowel Diseases, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Mental Health Issue, Inflammatory Bowel Diseases
- What is being tested?
- dCBI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2022to 8 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Developmental delay
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
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
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.
Read the 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.
- Conditions
- Mental Health Issue, Inflammatory Bowel Diseases
- Being tested
- dCBI
- Keywords
- mobile app, digital behavioral tool, adolescent and young adult
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dCBIBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: dCBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start30 Jul 2022
- Primary completion8 Mar 2023
- Study completion8 Mar 2023
Why it stopped: PI left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kim, University of Pittsburgh
- Investigators
- Sandra Kim, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461014
- Sponsor's protocol ID
- STUDY21100037
- Status last verified
- Jun 2023
- First submitted
- 12 Jul 2022
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will not be shared. Data will be shared at the aggregate level.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05461014
- Acronym / sponsor ID
- STUDY21100037
- Conditions
- Mental Health Issue, Inflammatory Bowel Diseases
- Keywords
- mobile app, digital behavioral tool, adolescent and young adult
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left the institution
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 30 Jul 2022 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital Cognitive Behavioral Intervention (DCBI) | Experimental | Behavioral: dCBIThe dCBI, RxWell, is a trans cognitive behavioral therapy (CBT) mobile app product addressing depression and anxiety that was developed based on standard CBT techniques. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Developmental delay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dCBIThe 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. | Behavioural | Digital Cognitive Behavioral Intervention (DCBI) |
Primary outcome
Change in anxiety severity over time
Time frame: 6 months
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
Time frame: 6 months
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.
1 secondary outcome
Change in Transition Readiness to Adult Care
Time frame: 6 months
Results and safety
The study was stopped early (reason given: PI left the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Individual participant dataSharing planned: No. Individual patient data will not be shared. Data will be shared at the aggregate level.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Kim, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dCBI in people with Mental Health Issue and Inflammatory Bowel Diseases, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left the institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety severity over time (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.