Improving Quality of Care With a Digital Behavioral Program in IBD Patient Centered Medical Home

If the patient is eligible for, interested in, and consents to, participating in this study,
the social worker will use the randomization program (social worker remains blind to random
assignment until the moment this group assignment is delivered to the patient) to determine
to which group the patient is randomized. The Social Worker will provide the patient's MRN,
name, date of birth and contact information to the UPMC research team. The UPMC research team
will generate a unique ID for each patient. Lantern is a behavioral health app that is used
to help people manage their stress and anxiety. There are many modules that the subjects will
be offered through the course of Lantern. There is a coach available to the subject who will
guide the subject through the modules and be available for check-ins.For those patients that
are randomized to Lantern at baseline, they will be provided a postcard with a sign up code
so they can sign up directly on their mobile device. The PCMH research assistant will assign
a study ID at the time of consent and study enrollment and enter this into the UPMC study
database. Once patient is in Lantern, they are assigned a Lantern User ID. The Lantern User
ID along with DOB and name will be sent to the UPMC research team through a secure VPN
connection so that a crosswalk can be created in the UPMC study database that links their
study IDs and Lantern User IDs. Patients will be recommended to start and use the anxiety
management program to help address their anxiety/stress symptoms. The techniques to try are
available for participants to access at any time. The coaches are not therapists, but are
there to provide information and encouragement to the patient. To keep confidentiality, the
coach only knows the first name of the patient. The coordinator of the coaches has access to
the patient's identifying information if the patient has an escalation in distress/anxiety
that needs to be addressed. This information will be passed to the PI when necessary as part
of the escalation procedures (as outlined above in Section 2.5.2 and in the attachments-
Escalation Procedure). The personally identifying information is held internally within the
Amazon web services at Lantern. The coaches for the patients have access to an internal
Coaching Portal where they have a dashboard for each of their users. This dashboard includes
all information that the user inputs into the Lantern program, including both their direct
messages to coaches and all content they complete in the program. Coaches receive a
notification when users complete a path in the program or send them a message, which prompts
their response to the individual (See Other Attachments - Example Messages from Lantern
Coaches to read examples of how the coach interacts with the user as well as Sample Lantern
Content.) The 6 core components include:1. Education and awareness about stress and how
thoughts, emotions, and behaviors are interrelated. This provides the rationale of the
cognitive behavioral model. In this unit, patients will learn how you can change your
thoughts and behaviors to change your emotions. 2. Relaxation - patients learn several
empirically supported relaxation techniques to manage stress/anxiety. 3. Thoughts - This unit
is about the stories we tell ourselves and how these stories determine our mood and help us
decide what actions we will take. This component also guides patients how to challenge their
assumptions about these thoughts/stories to create new stories.4. Behavior Change and
Exposure - patients will learn how to avoid things that contribute to stress and identify
adaptive coping activities. Through learning the principle of exposure, patients learn how
exposing themselves to anxiety provoking situations can help to overcome anxiety in the
long-term.5. Mindfulness - This unit is about taking a step back from our thoughts and
feelings to interrupt the thoughts-feelings-behaviors cycle. Several mindfulness exercises
are offered so the patient can find the type that feels best for them.6. Habit
formation/Maintaining skills - patients will reflect on what they have learned and work on
making a habit out of the most effective techniques.Lantern, the third-party program
provider, will collect de-identified usage data (e.g., progression through the program,
frequency of messages to coaches, and techniques completed) and quantitative data (e.g.,
anxiety score responses) as the patients' progress through the program. Lantern internally
has a database that tracks user progress through the programs, so they understand how
patients have moved through the program. This de-identified data will be sent to the UPMC
study staff coded only with the patient's unique ID. At several time points, Lantern will
push self-report validated questionnaires (e.g., GAD7) to patients enrolled in Lantern via
their Qualtrics account. Lantern's Qualtrics Account is a third party, HIPAA compliant survey
tool. Thrive Network, Inc. has a Business Associate Agreement (BAA) with Lantern's Qualtrics
Account and owns all data collected through surveys. Lantern will share this de-identified
self-report questionnaire data with the UPMC clinical team using unique Lantern User IDs.
Lantern's coaches will not have access to any of the questionnaire data collected via
Qualtrics. For those patients randomized to PCMH Behavioral Health control condition at
baseline to 3 months, they will receive PCMH care as usual without any skills-based behavior
therapy. Standard behavioral health clinical monitoring will continue to occur according to
best practice guidelines. Specifically, this means that for patients with a baseline GAD7 >
10 will receive a phone call from a PCMH behavioral health provider to do a mood check at one
month after baseline assessment. Regardless of baseline GAD7 score, if the baseline PHQ2 > =
3, a behavioral health provider will conduct the phone call for a mood check at one month
follow up. From the baseline PHQ8 assessments, we will extrapolate the PHQ2 to use for
clinical decision making to rely on affective components of depression rather than somatic
component as this overlaps substantially with inflammatory-related medical conditions. At 3
month study follow-up, patients in both groups will be re-assessed with the study assessment
battery (outlined in measures section and in Table x). Non-responders will be re-randomized
to an adaptive care strategy. The 3 month GAD7 assessment will be used to determine
'responder' vs. 'non-responder' status. In the Lantern group, patients are defined as
'non-responders' if their 3 month GAD7 is > = 11 or if there is < 4 point reduction on GAD7.
These cutoff scores and magnitude of change are based on the literature establishing
thresholds for 'treatment response'. We conservatively estimate a 40% non-response rate in
Mobile anxiety self-management program group based on CBT for anxiety meta-analyses. In the
PCMH Behavioral Health control condition, 'non-responders' are defined as 3 month GAD7 scores
increasing by >=3 points from baseline. It's estimated that 1/2 of patients in PCMH
(behavioral health WL control) will either be responders or remain stable/unchanged based on
findings of natural course of in GAD. At 3 months, the Lantern non-responders will be
re-randomized to either 1) PCMH care as usual (i.e., this includes individual skills-based
behavioral therapy provided by behavioral health providers) or 2) PCMH care as usual +
Lantern. The PCMH Behavioral Health Control group non-responders will be re-randomized to
either 1) PCMH care as usual or 2) Lantern only. For PCMH care as usual groups, individual
CBT will be provided as follows: if 3 month GAD7 > = 15 and/or PHQ2 >=4, the patient will be
offered every other week CBT sessions. If 3 month GAD7 and PHQ2 are below these thresholds,
then patients will be offered monthly individual CBT sessions. The 'Responders' will continue
in their original randomly assigned group (either Lantern or PCMH Behavioral Health control
group). All study participants will engage in their respective care approaches for another
three-month period and then the same study assessment battery will be re-administered at 6
months. For those patients who were defined as 'responders/stable' at 3 months within the
PCMH Behavioral Health Control group, standard behavioral health clinical monitoring will
continue. Specifically, if 3 month GAD7 > = 15 and/or 3 month PHQ2 >=3, then a behavioral
health provider will call the patient monthly to conduct mood check ins. A subset of
participants (12 completers and 12 non-completers)who were offered the stress management app
will be asked to participate in an in-depth qualitative phone interview 6 months after
enrollment. Participants will be randomly selected and will include those who completed and
those who did not complete the program. The interviews will be conducted by research staff
contacting the randomly selected subjects. The qualitative interview will explore patient's
experience with the program and areas of suggested improvement. All interviews will be
audio-recorded and transcribed verbatim. All study participants, regardless of the condition
to which they are assigned, will complete the study assessment battery at 9 and 12 months as
well.

Inclusion Criteria:

- Individuals who are seeking medical care at UPMC IBD Patient Centered Medical Home
(PCMH); age 21-55; GAD7 score >/= 8, English speaking and capable of understanding the
informed consent and providing consent; access to a Smartphone

Exclusion Criteria:

- No psychotherapy within PCMH within past 6 months including with the psychologist•
Stable on psychiatric meds for 4 weeks• Personality pathology or PTSD (captured from
DSM-V cross cutting symptoms inventory already being used as part of routine care
screening in this clinic)• Severe mood disorder (PHQ8 > 14) or evidence of active
suicidality or psychosis (brief screen conducted by SWer in clinic using DSM-V cross
cutting symptom inventory) to assess for psychosis, etc. will serve as our study
screener • No smartphone