Digital Behavioral Interventions in Inflammatory Bowel Disease

  • STATUS
    Recruiting
  • End date
    Jul 14, 2023
  • participants needed
    50
  • sponsor
    Montefiore Medical Center
Updated on 14 September 2022
anxiety
behavior therapy
ulcerative colitis
inflammatory bowel disease
crohn's disease
enteropathy
colitis
ulceration

Summary

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.

Description

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.

Details
Condition Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases, Stress, Psychological, Depression, Anxiety
Treatment Internet based cognitive behavioral therapy, Digital mood tracking
Clinical Study IdentifierNCT04861597
SponsorMontefiore Medical Center
Last Modified on14 September 2022

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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