Digital Behavioral Interventions in Inflammatory Bowel Disease

Study Overview
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Brief Summary
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Given the bidirectionality between psychological distress and disease activity in inflammatory bowel disease (IBD), whereby increased psychological distress exacerbates disease activity and vice versa, psychosocial aspects of IBD care are receiving increased attention. However, proposed interventions are generally resource-intensive and have been tested in majority white populations. While people of color are an increasing segment of the IBD population, they are currently underrepresented in research studies. The purpose of this study is to evaluate the efficacy and implementation of internet-based cognitive behavioral therapy (iCBT) among IBD patients of color with elevated psychological distress.

Detailed Description
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The investigators propose a 1:1 randomized trial design to evaluate the efficacy of iCBT among a population of Black and Latinx IBD patients and to assess factors influencing its implementation. Patients within the integrated health system at Montefiore Medical Center will be actively recruited and screened to identify those with elevated psychological distress. Eligible patients will be randomized to receive 8 weeks of iCBT or digital mood tracking to evaluate the effect of iCBT on levels of psychological distress, HRQoL and disease activity post-intervention. The investigators will also evaluate individual process level barriers and facilitators to iCBT implementation via surveys and semi-structured interviews.

Official Title
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Digital Behavioral Interventions in Inflammatory Bowel Disease

Conditions
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Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases, Stress, Psychological, Depression, Anxiety

Intervention / Treatment
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* Behavioral: Internet based cognitive behavioral therapy
* Behavioral: Digital mood tracking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 years race/ethnicity self-identified as Black/African American or Hispanic/Latino established diagnosis of Crohn's disease or ulcerative colitis elevated psychological distress: at least one T-score within two standard deviations above the mean in the domains of anxiety or depression on the National Institutes of Health Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) with or without a T-score within two standard deviations above the mean for perceived stress on the National Institute of Health Toolbox Perceived Stress Scale (Perceived Stress Scale) internet access (smartphone/mobile device with data plan, computer with internet) ability to provide informed consent in English or Spanish Exclusion Criteria: PROMIS-29 anxiety or depression T-scores in the severe range (above 2 standard deviations) Current suicidal ideation, past suicidal attempt or hospitalization

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based cognitive behavioral therapy<br>The iCBT platform selected for use in this study (Sanvello™) is an evidence-based mobile app created by clinical experts that has been shown to decrease depression, anxiety, and stress and to increase self-efficacy in a non-IBD population.15 App features include: daily mood tracking; guided journeys (e.g. psychoeducational content providing background information about cognitive behavioral therapy and instructing users on how to use app tools to maintain motivation and interest); coping tools (e.g. meditation, goal setting, and negative thought redirecting activities); weekly progress assessments; community support board. | Behavioral: Internet based cognitive behavioral therapy<br>* Participants with elevated psychological distress will receive 8 weeks of internet-based cognitive behavioral therapy<br>|
| Active Comparator: Digital mood tracking<br>The digital mood tracking application (app) selected for this study (PixelTM) allows participants to log their mood each day by way of a facial expression emoji and a free-text box. This app is commercially available free of charge through iOS and Android app stores with English and Spanish language options. | Behavioral: Digital mood tracking<br>* Participants with elevated psychological distress will receive 8 weeks of digital mood tracking<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety and/or depression | Level of psychological distress measured by the sub-score domains of anxiety and/or depression on the National Institutes of Health Patient Reported Outcomes Measurement Information System-29 assessment tool (minimum score 4, maximum score 20; higher scores indicate higher anxiety or depression). | 4 weeks post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Score | Level of perceived stress as measured by the National Institutes of Health Perceived Stress Scale (minimum 14, maximum 75; higher scores indicate higher perceived stress) | 4 weeks post-intervention | 
| Health-related Quality-of-Life | Health-related Quality-of-Life as measured by the overall National Institutes of Health Patient Reported Outcomes Measurement Information System-29 | 4 weeks post-intervention | 
| Crohn's Disease Activity | Measured by Short Crohn's Disease Activity Index in individuals with Crohn's disease (minimum 0, maximum 600; higher scores indicate more disease activity) | 4 weeks post-intervention | 
| Ulcerative Colitis Disease Activity | Measured by partial Mayo Score (minimum 0, maximum 6; higher score indicates more disease activity) in individuals with ulcerative colitis | 4 weeks post-intervention |