Improving Quality of Care With a Digital Behavioral Program in IBD Patient Centered Medical Home
Condition: Anxiety; Irritable Bowel Disease
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional

Summary: 
      Anxiety disorders and depression are more prevalent in patients living with inflammatory
      bowel disease (IBD) than in healthy controls. Approximately 40% of IBD patients have elevated
      anxiety. Given the robust effectiveness of cognitive behavioral approaches for anxiety
      disorders and the paucity or mixed findings of cognitive behavioral approaches for anxiety in
      IBD, an integrated behavioral approach and combining face to face and online cognitive
      behavioral modalities is recommended for IBD patients with anxiety.
    

Detailed description: 
      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.
    

Intervention name(s): Digital behavioral program app
Intervention type(s): Behavioral
Intervention description(s): mobile app utilizing cognitive behavioral techniques to help alleviate anxiety
Other intervention name(s): Lantern
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Comparison between cognitive behavioral app and care as usual.
Masking: None (Open Label)
Primary purpose: Other