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

NCT ID: NCT06646757

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

803 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-14

Study Completion Date

2025-10-15

Brief Summary

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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.

Detailed Description

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Conditions

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Ulcerative Colitis (UC) Crohn Disease (CD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

No resource provision

Group Type NO_INTERVENTION

No interventions assigned to this group

Arm 2

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

Group Type EXPERIMENTAL

PEER

Intervention Type BEHAVIORAL

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

Arm 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

Group Type EXPERIMENTAL

HELP

Intervention Type BEHAVIORAL

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

Arm 4

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

Group Type EXPERIMENTAL

HELP

Intervention Type BEHAVIORAL

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

PEER

Intervention Type BEHAVIORAL

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

Arm 5

"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)

Group Type EXPERIMENTAL

CBT

Intervention Type BEHAVIORAL

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)

Arm 6

"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

Group Type EXPERIMENTAL

CBT

Intervention Type BEHAVIORAL

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)

PEER

Intervention Type BEHAVIORAL

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

Arm 7

"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

Group Type EXPERIMENTAL

CBT

Intervention Type BEHAVIORAL

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)

HELP

Intervention Type BEHAVIORAL

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

Arm 8

"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

Group Type EXPERIMENTAL

CBT

Intervention Type BEHAVIORAL

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)

HELP

Intervention Type BEHAVIORAL

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

PEER

Intervention Type BEHAVIORAL

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

Arm 9

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

Group Type EXPERIMENTAL

APP

Intervention Type BEHAVIORAL

1\) 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

My 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

Group Type EXPERIMENTAL

APP

Intervention Type BEHAVIORAL

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

PEER

Intervention Type BEHAVIORAL

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

Arm 11

My 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

Group Type EXPERIMENTAL

APP

Intervention Type BEHAVIORAL

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

HELP

Intervention Type BEHAVIORAL

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

Arm 12

My 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

Group Type EXPERIMENTAL

APP

Intervention Type BEHAVIORAL

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

HELP

Intervention Type BEHAVIORAL

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

PEER

Intervention Type BEHAVIORAL

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

Arm 13

My 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)

Group Type EXPERIMENTAL

APP

Intervention Type BEHAVIORAL

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

CBT

Intervention Type BEHAVIORAL

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)

Arm 14

My 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

Group Type EXPERIMENTAL

APP

Intervention Type BEHAVIORAL

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

CBT

Intervention Type BEHAVIORAL

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)

PEER

Intervention Type BEHAVIORAL

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

Arm 15

My 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

Group Type EXPERIMENTAL

APP

Intervention Type BEHAVIORAL

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

CBT

Intervention Type BEHAVIORAL

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)

HELP

Intervention Type BEHAVIORAL

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

Arm 16

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

Group Type EXPERIMENTAL

APP

Intervention Type BEHAVIORAL

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

CBT

Intervention Type BEHAVIORAL

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)

HELP

Intervention Type BEHAVIORAL

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

PEER

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type 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)

Intervention Type 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

Intervention Type BEHAVIORAL

PEER

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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853060

Identifier Type: -

Identifier Source: org_study_id

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