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

NCT06646757 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 803

Last updated 2026-01-09

No results posted yet for this study

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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-14
Primary Completion
2025-10-15
Completion
2025-10-15

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06646757 on ClinicalTrials.gov