Exploring Multiple Self-Help Interventions to Promote Self-Efficacy and Overcome Disability
EMPOWER-IBD
1 other identifier
interventional
803
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 14, 2024
CompletedFirst Submitted
Initial submission to the registry
August 21, 2024
CompletedFirst Posted
Study publicly available on registry
October 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2025
CompletedJanuary 9, 2026
January 1, 2026
1.2 years
August 21, 2024
January 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in IBD-related disability based on the validated IBD-Disability Index
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).
12 weeks
Secondary Outcomes (1)
Change in IBD self-efficacy as measured by the IBD Self-Efficacy Scale Wasson Health Confidence Scale
12 weeks
Study Arms (16)
Arm 1
NO INTERVENTIONNo resource provision
Arm 2
EXPERIMENTALPower of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation
Arm 3
EXPERIMENTALIBD 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
Arm 4
EXPERIMENTALIBD 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 Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation
Arm 5
EXPERIMENTAL"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)
Arm 6
EXPERIMENTAL"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) Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation
Arm 7
EXPERIMENTAL"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) 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
Arm 8
EXPERIMENTAL"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) 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 Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation
Arm 9
EXPERIMENTAL1\) My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
Arm 10
EXPERIMENTALMy IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation
Arm 11
EXPERIMENTALMy IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs 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
Arm 12
EXPERIMENTALMy IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs 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 Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation
Arm 13
EXPERIMENTALMy IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs "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)
Arm 14
EXPERIMENTALMy IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs "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) Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation
Arm 15
EXPERIMENTALMy IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs "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) 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
Arm 16
EXPERIMENTAL1. My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs 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) 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 4. Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation
Interventions
1\) My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs
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)
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
4\) Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \& Colitis Foundation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2024
First Posted
October 17, 2024
Study Start
August 14, 2024
Primary Completion
October 15, 2025
Study Completion
October 15, 2025
Last Updated
January 9, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share