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Behavioural Intervention

Self-Help Interventions for Crohn's Disease (EMPOWER-IBD Trial)

N/A

Waitlist Available

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults (age ≥ 18 years) with IBD and moderate-to-severe IBD-related Disability Index score > 35

Be older than 18 years old

Must not have

Inability or unwillingness to participate in the interventions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at different ways to help patients with moderate-to-severe IBD improve their ability to manage their condition and reduce disability. Participants will receive four different self-help resources for free - a

Who is the study for?

This trial is for adults over 18 with moderate-to-severe IBD-related disability (score > 35). Participants must be able to consent, complete surveys, and join focus groups in English. It's not for those with low/no disability, unwilling to engage in interventions or unable to download apps due to language limitations.

What is being tested?

EMPOWER-IBD tests the effectiveness of four self-help resources: a book, smart app, help center, and peer mentorship on reducing IBD-related disability and boosting self-efficacy. This randomized trial has multiple sites and arms where participants are assigned different combinations of these tools.

What are the potential side effects?

Since this study involves behavioral interventions rather than medications, traditional side effects are not expected. However, participants may experience varying levels of engagement or psychological impact from the materials provided.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18 and have a severe form of IBD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am unable or unwilling to follow the study's treatment plan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

16Treatment groups

Experimental Treatment

Active Control

Group I: Arm 9Experimental Treatment1 Intervention

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 II: Arm 8Experimental Treatment3 Interventions

"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 III: Arm 7Experimental Treatment2 Interventions

Group IV: Arm 6Experimental Treatment2 Interventions

"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 V: Arm 5Experimental Treatment1 Intervention

"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 VI: Arm 4Experimental Treatment2 Interventions

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 VII: Arm 3Experimental Treatment1 Intervention

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 VIII: Arm 2Experimental Treatment1 Intervention

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

Group IX: Arm 16Experimental Treatment4 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

Group X: Arm 15Experimental Treatment3 Interventions

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 XI: Arm 14Experimental Treatment3 Interventions

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 XII: Arm 13Experimental Treatment2 Interventions

Group XIII: Arm 12Experimental Treatment3 Interventions

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 XIV: Arm 11Experimental Treatment2 Interventions

Group XV: Arm 10Experimental Treatment2 Interventions

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 XVI: Arm 1Active Control1 Intervention

No resource provision

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CBT

2013

Completed Phase 3

~4220

HELP

2017