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OpenTrials
Completed

NCT Number: NCT06646757

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

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.

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Key information

Conditions

Ulcerative Colitis (UC) Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn Disease (CD) Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (age ≥ 18 years) with IBD and moderate-to-severe IBD-related (IBD) Disability Index score > 35 26,27)
  • Able to consent, complete surveys, and participate in focus groups in English.

Exclusion criteria

  • No/low disability (IBD-DI < 35) on the baseline survey
  • Inability or unwillingness to participate in the interventions
  • Inability to download apps from the Apple AppStore or Google Play store (necessary to engage with the smartapp intervention)
  • Limited English proficiency (necessary because some interventions are currently only offered in English)

Treatment and study plan

App

Behavioral
  • My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs

CBT

Behavioral
  • "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)

HELP

Behavioral
  • 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

PEER

Behavioral
  • Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's & Colitis Foundation

Primary outcomes

  1. Change in IBD-related disability based on the validated IBD-Disability Index

    Time frame: 12 weeks

    The study seeks to identify any changes in IBD-related disability pre-post intervention (week 0 and week 12) as measured by the IBD Disability Index (IBD-DI). IBD-related disability is measured by the validated 14-item IBD-disability index (yes-no responses and 1-5 point Likert scales) for limitations across 5 domains of International Classification of Functioning, Health, and Disability. Higher score indicates more disability. Total score ranges from 0-100, interpreted as 0-20 (no disability), 20-35 (mild disability), 35-50 (moderate disability), and 50-100 (severe disability).

Secondary outcomes

  1. Change in IBD self-efficacy as measured by the IBD Self-Efficacy Scale Wasson Health Confidence Scale

    Time frame: 12 weeks

    The study seeks to identify any changes in IBD self-efficacy as measured in the 13-item IBD-Self Efficacy Wasson Health Confidence Scale. This is one survey. A higher score indicates more confidence in self-efficacy and health confidence relative to chronic illness. Total score ranges from 0-130

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Acronym: EMPOWER-IBD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 17, 2024
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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