NCT04861597

Digital Behavioral Interventions in Inflammatory Bowel Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	Internet based cognitive behavioral therapy	Participants with elevated psychological distress will receive 8 weeks of internet-based cognitive behavioral therapy
BEHAVIORAL	Digital mood tracking	Participants with elevated psychological distress will receive 8 weeks of digital mood tracking

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-03-22
• Completion: 2023-03-22
• First posted: 2021-04-27
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: United States