Digital Behavioral Interventions in Inflammatory Bowel Disease

Montefiore Medicine Academic Health System

Status: Completed

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

Treatments: Behavioral: Internet based cognitive behavioral therapy; Behavioral: Digital mood tracking

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04861597

UL1TR002556 (U.S. NIH Grant/Contract)

2021-12896

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Internet-based cognitive behavioral therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Internet based cognitive behavioral therapy

Digital mood tracking

Active Comparator group

Description:

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.

Treatment:

Behavioral: Digital mood tracking