NCT06646757

Exploring Multiple Self-Help Interventions to Promote Self-Efficacy and Overcome Disability

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 803 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

EMPOWER-IBD aims to identify behavioral interventions to strengthen patients' self-efficacy for self-management as a mechanism to reduce IBD-related disability. This multisite, randomized controlled trial with 16 arms will randomize adults with moderate-to-severe IBD-related disability to a combination of four multimodal behavioral interventions to test their clinical effectiveness in reducing IBD-related disability and improving self-efficacy. The interventions are four existing, publicly available disease-specific self-help resources offered at no cost to the participants: a book, smart app, help center, and peer mentor. Participants will complete online surveys and may engage in virtual focus groups. Participants may receive an honorarium (e-gift card) and/or be entered into a lottery for a giftcards post-survey completion and focus group participation.

Conditions

• Ulcerative Colitis (UC)
• Crohn Disease (CD)

Interventions

Type	Name	Description
BEHAVIORAL	APP	1\) My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
BEHAVIORAL	CBT	2\) "Coping with Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)
BEHAVIORAL	HELP	3\) IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost
BEHAVIORAL	PEER	4\) Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation

Timeline

• Start date: 2024-08-14
• Primary completion: 2025-10-15
• Completion: 2025-10-15
• First posted: 2024-10-17
• Last updated: 2026-01-09

Locations

1 site across 1 country: United States