Clinical trial NCT04861597: Digital Behavioral Interventions in Inflammatory Bowel Disease
Official title: Digital Behavioral Interventions in Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn Disease
Ulcerative Colitis
Inflammatory Bowel Diseases
Stress, Psychological
Depression, Anxiety
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-04-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of Psychological Distress
timeFrame: Post-4 week trial intervention
Secondary outcomes:
measure: Disease Activity by Short Crohn's Disease Activity Index
timeFrame: Post-4 week trial intervention
measure: Disease Activity by Simple Clinical Colitis Activity Index
timeFrame: Post-4 week trial intervention
measure: Perceived Stress Score
timeFrame: Post-4 week trial intervention
measure: Health-related Quality-of-Life
timeFrame: Post-4 week trial intervention
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Hutchinson Campus
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Ruby Greywoode, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.