Digital Behavioral Interventions in Inflammatory Bowel Disease
2 other identifiers
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2021
CompletedFirst Posted
Study publicly available on registry
April 27, 2021
CompletedStudy Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2023
CompletedResults Posted
Study results publicly available
September 19, 2024
CompletedSeptember 19, 2024
August 1, 2024
1.4 years
April 12, 2021
June 7, 2024
August 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Level of Psychological Distress
Level of psychological distress in participants over the prior 7 days was measured by combining the sub-score domains of anxiety and depression from the National Institutes of Health Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) assessment tool. PROMIS-29 is a 29-item form that includes 4 questions in each of the domains of anxiety and depression. Group mean scores of these 8 items are composited. 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.
Post-4 week trial intervention
Secondary Outcomes (4)
Disease Activity by Short Crohn's Disease Activity Index
Post-4 week trial intervention
Disease Activity by Simple Clinical Colitis Activity Index
Post-4 week trial intervention
Perceived Stress Score
Post-4 week trial intervention
Health-related Quality-of-Life
Post-4 week trial intervention
Study Arms (2)
Internet-based cognitive behavioral therapy
EXPERIMENTALThe 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.
Digital mood tracking
ACTIVE COMPARATORThe 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.
Interventions
Participants with elevated psychological distress will receive 8 weeks of internet-based cognitive behavioral therapy
Participants with elevated psychological distress will receive 8 weeks of digital mood tracking
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- PROMIS-29 anxiety or depression T-scores in the severe range (above 2 standard deviations)
- Current suicidal ideation, past suicidal attempt or hospitalization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montefiore Hutchinson Campus
The Bronx, New York, 10461, United States
Related Publications (4)
Gracie DJ, Guthrie EA, Hamlin PJ, Ford AC. Bi-directionality of Brain-Gut Interactions in Patients With Inflammatory Bowel Disease. Gastroenterology. 2018 May;154(6):1635-1646.e3. doi: 10.1053/j.gastro.2018.01.027. Epub 2018 Jan 31.
PMID: 29366841BACKGROUNDMikocka-Walus A, Knowles SR, Keefer L, Graff L. Controversies Revisited: A Systematic Review of the Comorbidity of Depression and Anxiety with Inflammatory Bowel Diseases. Inflamm Bowel Dis. 2016 Mar;22(3):752-62. doi: 10.1097/MIB.0000000000000620.
PMID: 26841224BACKGROUNDMikocka-Walus A, Bampton P, Hetzel D, Hughes P, Esterman A, Andrews JM. Cognitive-behavioural therapy has no effect on disease activity but improves quality of life in subgroups of patients with inflammatory bowel disease: a pilot randomised controlled trial. BMC Gastroenterol. 2015 May 2;15:54. doi: 10.1186/s12876-015-0278-2.
PMID: 25934170BACKGROUNDTiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PMID: 40243391DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ruby Greywoode M.D. M.S., Assistant Professor of Medicine
- Organization
- Montefiore Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Ruby Greywoode, MD
Montefiore Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2021
First Posted
April 27, 2021
Study Start
November 1, 2021
Primary Completion
March 22, 2023
Study Completion
March 22, 2023
Last Updated
September 19, 2024
Results First Posted
September 19, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share