Digital Behavioral Interventions in Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

Official title:

Digital Behavioral Interventions in Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04861597
• Other study ID #: 2021-12896
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: March 22, 2023

Study information

• Verified date: May 2023
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 22, 2023
• Est. primary completion date: March 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Internet based cognitive behavioral therapy
Participants with elevated psychological distress will receive 8 weeks of internet-based cognitive behavioral therapy
• Digital mood tracking
Participants with elevated psychological distress will receive 8 weeks of digital mood tracking

Locations

Country	Name	City	State
United States	Montefiore Hutchinson Campus	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Mikocka-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. — View Citation

Mikocka-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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