Digital Behavioral Interventions in Inflammatory Bowel Disease
Phase: NA
Conditions: Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases, Stress, Psychological, Depression, Anxiety
Sponsor: Montefiore Medical Center

Digital Behavioral Interventions in 
Inflammatory Bowel Disease 
NCT04861597 
IRB NUMBER: 2021-12896 
IRB APPROVAL DATE: 09/21/2022 

Revised 4/17/13, 6/23/15, 06/29/2018
1
Digital Behavioral Interventions in Inflammatory Bowel Disease
1) Background/Significance
    Crohn’s disease and ulcerative colitis, together known as IBD, are conditions of chronic 
intestinal inflammation that often have a relapsing and remitting course in affected 
individuals. Historically, IBD was considered a condition almost exclusively affecting 
individuals of European ancestry, while IBD is now increasingly recognized in diverse 
populations. 1-3  Previous studies have shown worse clinical outcomes among African 
American and Hispanic IBD patients that has been attributed in part to psychosocial 
factors.4,5    
   Psychological distress specifically has been linked to increased disease activity in IBD.6 A 
recent study, in fact, found evidence for bi-directional effects between IBD disease activity 
and psychological distress, whereby increased psychological distress exacerbates disease 
activity and vice versa.7 Compared to healthy controls, individuals with IBD have increased 
prevalence of anxiety and depression: 9.6% versus 19.1% and 13.4% versus 21.2%, 
respectively.8 
   Given elevated levels of psychological distress and its relationship to disease activity in 
IBD, studies have promoted increased psychosocial screening though people of color are 
under-represented in these studies. For example, the NIH PROMIS measures are patient-
reported outcome tools based on Item Response Theory and calibrated on large samples of 
the general population that have gained popularity for their rigorous testing.9,10 PROMIS 
measures have been tested in IBD using disease-specific activity and HRQoL instruments 
with results suggesting construct validity.11 Notably, however, the racial composition in one 
of the main trials was about 92% White and only 2-3% African American or Hispanic. As 
recent estimates of the prevalence of IBD in the US suggest that up to approximately 25% 
are people of color,12 there is clearly under-representation of people of color in IBD 
psychosocial screening studies. It is also unclear whether people of color are adequately 
represented in studies focused on interventions to address psychological distress in IBD. 
   Among the proposed interventions to address psychological distress in IBD, cognitive 
behavioral therapy (CBT) has the most evidence of effectiveness.13,14 CBT is a form of 
psychotherapy in which individuals are taught to identify and modify maladaptive thinking 
and behavior in order to improve their psychological status and coping skills. Results of 
previous studies suggest that the positive effects of CBT on depression symptoms and 
quality of life in IBD are experienced within subgroups of patients, such as those with 
elevated psychological distress, rather than unselected IBD patients. Of the few trials that 
make up the literature on this intervention in IBD, there is no mention of focusing on people 
of color. 
  In the largest trial using CBT in IBD patients, subjects were offered their choice of either in-
person CBT or internet-based cognitive behavioral therapy (iCBT).14 Nearly all participants 
chose iCBT, which is CBT delivered through a digital platform. Importantly, the mode of CBT 
delivery was not associated with the outcome in the trial, suggesting that patients who use 
iCBT derive similar benefits as those receiving in-person CBT. Results of the trial indicated 
that quality of life was significantly improved only among the select group of those classified 
at baseline as “in need” (e.g. high IBD disease activity, poor mental health). The study was 
not designed to test the effect of iCBT in patients specifically with psychological distress and 
further research is needed to test iCBT among these individuals. Notably, the racial 
demographics of this trial were not specified. 
2) Study Design
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IRB APPROVAL DATE: 09/21/2022

Revised 4/17/13, 6/23/15, 06/29/2018
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     We 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 our 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 48 weeks of iCBT or digital mood tracking to 
evaluate the effect of iCBT on levels of psychological distress, HRQoL and disease activity 
post-intervention. We will also evaluate individual and process level barriers and facilitators 
to iCBT implementation via surveys and semi-structured interviews. The study objectives will 
be achieved through the following specific aims: 
Aim 1: Investigate the efficacy of iCBT among Black and Latinx IBD patients with elevated 
psychological distress
We predict that compared to those who receive digital mood tracking, patients who are 
allocated to iCBT will have (a) lower psychological distress, as measured by the National 
Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System 
(PROMIS) anxiety and depression scores and NIH Toolbox Perceived Stress Scale scores, 
(b) higher HRQoL on overall PROMIS-29 scores and (c) lower disease activity, as measured 
by patient-reported disease activity indices.
Aim 2: Evaluate implementation of iCBT among Black and Latinx IBD patients
We predict that (a) behavioral factors, such as elevated psychological distress, high self-
efficacy, coping, and spirituality will be the strongest predictors of acceptance of iCBT and 
that other factors such as younger age, higher educational attainment, recent IBD diagnosis, 
and high disease activity will be associated with higher iCBT use and (b) modifiable 
individual and process level barriers and facilitators of iCBT use will be identified. 
     Participants will have IBD and elevated psychological distress and be recruited from the 
two outpatient clinical sites where the research physician and senior key personnel practice. 
The total estimated IBD population with clinical visits at Einstein/Montefiore is approximately 
1,200 patients. In an average week, about 34 unique IBD patients receive care at one of the 
two study sites of which about 19% are Black and 30% are Latinx. About 85% have internet 
access, using active patient portal registration in the electronic medical record as a rough 
proxy. Based on estimates from the literature, the prevalence of anxiety or depression in 
IBD is around 20% and up to 66% with active disease.8 Thus, we estimate that on a weekly 
basis at least 6 and up to 22 Black or Latinx IBD patients attending a study site will have 
elevated anxiety or depression. 
     All consenting participants will complete a baseline questionnaire. Eligible participants 
will undergo 1:1 randomization using computer-generated variable 2 and 4 block allocation 
to either the iCBT or the digital mood tracking study arm. Allocation sequence will be 
concealed from the study team using opaque sealed envelopes. At the time of participant 
consent, the research physician will select the next consecutive envelope that will determine 
participant group assignment to either iCBT or digital mood tracking. All participants will 
receive a one-page brochure on mental health recommendations from the National Institute 
of Mental Health. Participants initially randomized to the digital mood tracking app will be 
offered 84 weeks of iCBT after completing the post-intervention study assessment/interview.
     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. 
     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. 
Study participants will receive a 2-month subscription for the app. Subscription is covered by 
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IRB APPROVAL DATE: 09/21/2022

Revised 4/17/13, 6/23/15, 06/29/2018
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various health insurance plans. The cost for individuals who do not qualify for health 
insurance coverage will come from the study budget. Participants will be instructed to export 
from the app a weekly data use report to the research physician’s Montefiore email. The 
research physician will be linked to participant usage and progress through the app. There is 
an emergency resources section within the app that includes information on crisis help-lines 
and other resources for users in emergency situations. The app is available for use in iOS 
and Android systems as well as online through any web browser. App content is available in 
English with text translations in Spanish. 
     All participants will receive a unique link to complete a follow-up questionnaire at 48 
weeks post intervention (Table 1). Non-responders will receive a reminder phone call twice 
weekly for 2 weeks and thereafter be considered lost to follow-up.
Table 1. Timeline and Sources of Data 
Baseline - REDCap Questionnaire (completed by patient at office visit or remotely)
Socio-demographics
Assessment Tools
Clinical features

Age

Race/ethnicity 

Sex

Birthplace 

Primary language 

Educational attainment

Employment status 

Health insurance 

Marital status

IBD disease activity index: Short Crohn’s 
Disease Activity Index for Crohn’s disease 
or Simple Clinical Colitis Activity Index for 
ulcerative colitis  

PROMIS-29

Perceived Stress Scale

PROMIS Self-efficacy Managing Emotions

PhenX Toolkit – Spirituality

Brief Resilient Coping Scale

IBD phenotype

Disease duration 

IBD medications

Previous/current psychiatric 
diagnosis, suicidal ideation 
or hospitalization 
Follow-up at 84 weeks REDCap Questionnaire (completed by patient remotely)
Assessment Tools

IBD disease activity index: Short Crohn’s 
Disease Activity Index for Crohn’s disease 
or Simple Clinical Colitis Activity Index for 
ulcerative colitis

PROMIS-29

Perceived Stress Scale

PROMIS Self-efficacy Managing Emotions
3) Study Population 
We aim to recruit 25 patients in each study arm for a total of 50 participants. Eligibility will be 
restricted to: 

age ≥ 18 years 

race/ethnicity self-identified as Black/African American or Hispanic/Latinx 

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 are: 

PROMIS-29 anxiety or depression T-scores in the severe range (above 2 standard 
deviations)

Current suicidal ideation, past suicidal attempt or hospitalization
4) Participant Recruitment 
IRB NUMBER: 2021-12896
IRB APPROVAL DATE: 09/21/2022

Revised 4/17/13, 6/23/15, 06/29/2018
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Recruitment will be active and occur during in-person study site visits. If in-person visits are 
not possible (e.g. ongoing public health crisis), recruitment will occur via telemedicine visits. 
All IBD patients will be invited to participate. We anticipate enrolling 1-2 participants weekly 
into the trial. 
     For patients recruited during an in-person visit, the research physician/assistant will 
approach patients during their visit who meet the screening questions (based on age, 
race/ethnicity, diagnosis of IBD, internet access) to confirm eligibility. After the informed 
consent process, patients will complete a study questionnaire via a REDCap survey on a 
study site computer. Responses to this initial questionnaire will determine eligibility for 
randomization into the study based on the inclusion/exclusion criteria. Upon completion of 
the questionnaire, computer-automated scores will be generated. Patients with severe 
psychiatric distress or suicidality will be linked to psychiatric services at Montefiore. The 
research physician/assistant will inform patients of their eligibility to be randomized into the 
trial.
     In the event in-person visits are not possible, patients will be recruited at the time of a 
telemedicine visit and asked the same initial screening questions to confirm eligibility. The 
informed consent process would take place over the telephone (see next section for details), 
and patients will be sent a unique link to the REDCap survey. Patients completing the 
questionnaire outside of an in-person visit will access and complete it on their own personal 
device. The research physician will receive a daily report of newly completed questionnaires 
to ensure adequate follow-up. Patients with severe psychiatric distress or suicidality will be 
linked to psychiatric services at Montefiore. The research physician/assistant will inform 
patients of their eligibility to be randomized into the trial.
5) Informed Consent 
Patients eligible for inclusion in the trial after confirmation of initial screening factors (age, 
race/ethnicity, diagnosis of IBD, internet access) will undergo an informed consent process 
using the attached consent form that includes discussion of study procedures, risks and 
benefits. The research physician/assistant will perform the informed consent process at the 
time of an office visit. If in-person office visits are not possible, patients will receive a copy of 
the informed consent form (emailed) in advance of the informed consent process, which 
would be conducted over the telephone by the research physician/assistant.
     Participants may receive a total of $40 for completing the two study questionnaires. They 
will receive a $20 gift card for completing a questionnaire at the beginning of the study and 
another $20 gift card if they complete a questionnaire at the end of the study. 
6) Risk/Benefit 
Risks of the study include a loss of confidentiality or privacy. Only the research study team 
will have access to study related documents and participants questionnaires. Study 
documents in a paper form will be stored in a study binder in a locked cabinet in the 
research physician’s office and accessed only by the research team. Study documents in 
digital form will be password protected and accessed only by the study team. Study 
questionnaires will be stored on the secure password protected online platform REDCap. 
Only the study team will have REDCap access to the study questionnaires. 
     Other risks of the study are the risk of discomfort or distress answering questions about 
mental health and discomfort or distress addressing mental health through a digital platform. 
It will be made clear to participants that they may choose not to answer any questions they 
feel uncomfortable with and that use of the iCBT application is completely voluntary. 
Participants are also directed to seek immediate medical attention in case of any severe 
psychological distress e.g. suicidality. The research physician will have a password-
protected provider interface to the iCBT platform that enables aggregate information 
regarding individual participant iCBT data usage.  
IRB NUMBER: 2021-12896
IRB APPROVAL DATE: 09/21/2022

Revised 4/17/13, 6/23/15, 06/29/2018
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7) Data Analysis
Aim 1: Investigate the efficacy of iCBT among Black and Latinx IBD patients with elevated 
psychological distress
The primary outcome will be the level of psychological distress (scores in the domains of 
anxiety and/or depression on the PROMIS-29 assessment tool) at 84 weeks between study 
arms. PROMIS-29 is a 29-item form that includes 4 questions in each of the domains of 
anxiety and depression.16 Higher scores indicate a greater level of the measured trait, and 
raw scores are converted to a T-score that centers at a mean of 50 with a standard 
deviation of 10 in the general population. The minimum clinically significant change in the 
domains of anxiety and depression has been shown to be 2.3-5.5 points.17,18 The other 
PROMIS-29 domains of physical function, fatigue, sleep disturbance, ability to participate in 
social roles, pain intensity and interference together give a measure of HRQoL. 
   Secondary outcomes will be the change in perceived stress, overall HRQoL and IBD 
disease activity. Perceived stress will be measured with the 10-item Perceived Stress Scale. 
Like PROMIS-29, higher scores indicate a higher level of the measured trait, and raw scores 
are converted to a T-score. The overall HRQoL will be measured with the PROMIS-29 
including the non-anxiety/depression domains. Disease activity will be measured by the 
Short Crohn’s Activity Index (for participants with Crohn’s disease) or Mayo sub-scores (for 
participants with ulcerative colitis).
     Primary analysis will be by intention-to-treat with participants analyzed in the group to 
which they were randomized. We will use descriptive statistics to summarize socio-
demographic and disease characteristics of both study groups and of app usage in the iCBT 
group: number of modules completed; weekly time spent on app; participation in community 
support groups. Our primary hypothesis is that participants in the iCBT group will have lower 
psychological distress scores compared to those in the digital mood tracking group post-
intervention. To test the association between psychological distress (T-score for anxiety, 
depression) and study group, we will use Student’s t-test if the normality assumption is met, 
or the Mann-Whitney U test if normality is appreciably violated. Assuming a minimum 
clinically significant change of a 5.5 points difference in T-scores between study groups with 
a standard deviation of ± 6 points, a sample size of 40 participants (20 in each arm) will be 
needed to have 80% power at an alpha of 0.05. Targeting a recruitment sample size of 50 
participants (25 in each arm) would allow for roughly 20% drop-out rate. 
   Our secondary hypotheses are that participants in the iCBT group will have lower 
perceived stress scores and higher HRQoL. To test these hypotheses, we will again use 
Student’s t-test if the normality assumption is met or the Mann-Whitney U test if normality is 
appreciably violated. Finally, we hypothesize that elevated disease activity at baseline 
(Short Crohn’s Disease Activity Index ≥ 150 or Mayo sub-scores ≥ 2) will be associated with 
achieving a minimum clinically significant change in T-score. To test the association 
between high baseline disease activity and minimum clinically significant change (as a 
dichotomous outcome), we will perform Chi-squared or Fisher’s exact test. 
Aim 2: Evaluate implementation of iCBT among Black and Latinx IBD patients
Participants randomized to iCBT will complete a survey as part of their follow-up 
assessment at 84 weeks to evaluate their acceptance of and satisfaction with iCBT. 
Participants will have the option to complete the post-intervention survey at the study site or 
off-site on their own personal device. Survey responses will be recorded and stored in 
REDCap. Participants will be asked a series of questions aimed at evaluating attitudes 
about receiving psychotherapy via a mobile application and how useful they found iCBT. 
Likert scale from strongly agree to strongly disagree will be used. At the end of the survey, 
participants will be invited to participate in semi-structured interviews. The interviews will be 
conducted by the research physician to elicit personal and logistical factors that may have 
influenced participant iCBT use. 
     Post-intervention surveys will be categorized with respect to level of participant 
acceptance of iCBT, while app usage will be analyzed as continuous (e.g. time spent on 
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app) and categorical (e.g. used during all 48 weeks). We hypothesize that participants more 
likely to accept iCBT will be those with: high self-efficacy (T-score above the mean of 50) 
compared to low self-efficacy (T-score at or below the mean of 50); high coping (Brief 
Resilient Coping Scale score ≥ 17) compared to low coping (score < 17); high spirituality 
(score ≥ 16) compared to low spirituality (score < 16); younger age (less than 40 years) 
compared to older age (at or over 40 years); higher educational attainment (high school 
graduate) compared to lower educational attainment (less than high school); recently 
diagnosed (within 2 years) compared to longstanding disease (over 2 years); and high 
disease activity (Short Crohn’s Disease Activity Index ≥ 150 or Mayo sub-scores ≥ 2) 
compared to low disease activity (Short Crohn’s Disease Activity Index < 150 or Mayo sub-
scores < 2). We will use descriptive statistics to summarize behavioral, socio-demographic 
and clinical factors associated with iCBT acceptance and greater app usage, and we will 
perform Chi-squared or Fischer’s exact tests to examine the associations. Interview 
responses will be examined for themes, and individual and process level barriers and 
facilitators to iCBT use will be summarized with respect to potentially modifiable features.
8) Data quality control and database management.
All study questionnaire responses will be entered and stored on REDCap, which will be 
password protected and accessed only by the research study team. Deidentified data from 
REDCap will be exported and analyzed on statistical software (e.g. Stata). 
9) Data Safety Monitoring – this is REQUIRED for greater than minimal risk research - 
researchers can be alerted to use our policy here as guidance
https://www.einstein.yu.edu/docs/administration/institutional-review-board/policies/dsm.pdf 
 
See attached document 
10) References: 
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IRB NUMBER: 2021-12896
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Revised 4/17/13, 6/23/15, 06/29/2018
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IRB NUMBER: 2021-12896
IRB APPROVAL DATE: 09/21/2022