Self-Help Interventions for Crohn's Disease

(EMPOWER-IBD Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Low disability, Limited English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

800 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on self-help resources rather than medication changes.

What data supports the effectiveness of the treatment EMPOWER-IBD Interventions for Crohn's Disease?

Research shows that self-management techniques, which are part of the EMPOWER-IBD Interventions, can lead to better symptom control and improved well-being for people with inflammatory bowel disease (IBD). Studies have found that when patients are more confident in managing their condition, they often experience better health outcomes. ^{1 2 3 4 5}

Is the self-help intervention for Crohn's Disease safe for humans?

The research on self-help interventions for inflammatory bowel disease (IBD) suggests that these programs, often involving self-management techniques, are generally safe for humans. However, specific safety data for Crohn's Disease is not detailed in the available studies. ^{1 2 3 4 5}

How is the EMPOWER-IBD treatment different from other treatments for Crohn's Disease?

The EMPOWER-IBD treatment is unique because it focuses on self-help and self-management techniques, which empower patients to manage their symptoms and improve their quality of life, rather than relying solely on medication. This approach is supported by evidence suggesting that self-management can lead to better outcomes in symptom control and psychological well-being. ^{1 3 4 5 6}

Eligibility Criteria

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.

Inclusion Criteria

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

Able to consent, complete surveys, and participate in focus groups in English.

Exclusion Criteria

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

No/low disability (IBD-DI < 35) on the baseline survey

Inability to download apps from the Apple AppStore or Google Play store (necessary to engage with the smartapp intervention)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to one of 16 arms to receive a combination of four multimodal behavioral interventions, including a book, smart app, help center, and peer mentor, to test their clinical effectiveness in reducing IBD-related disability and improving self-efficacy.

12 weeks

Follow-up

Participants are monitored for changes in IBD self-efficacy and IBD-related disability after the intervention.

4 weeks

Treatment Details

Interventions

• EMPOWER-IBD Interventions

Trial Overview 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.

Participant Groups

Group I: Arm 9 Experimental Treatment 1 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 8 Experimental Treatment 3 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 7 Experimental Treatment 2 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

Group IV: Arm 6 Experimental Treatment 2 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 5 Experimental Treatment 1 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 4 Experimental Treatment 2 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 3 Experimental Treatment 1 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 2 Experimental Treatment 1 Intervention

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

Group IX: Arm 16 Experimental Treatment 4 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 15 Experimental Treatment 3 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 14 Experimental Treatment 3 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 13 Experimental Treatment 2 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)

Group XIII: Arm 12 Experimental Treatment 3 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 11 Experimental Treatment 2 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

Group XV: Arm 10 Experimental Treatment 2 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 1 Active Control 1 Intervention

No resource provision

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Findings from Research

Self-management interventions for people with inflammatory bowel disease (IBD) have shown the most promise in improving outcomes related to symptoms, psychological well-being, and healthcare resource use, based on a review of 23 studies, including 13 randomized controlled trials.

While education plays a role in managing IBD, the review highlights that self-management techniques are more effective than education alone, suggesting that IBD specialist nurses could be key in facilitating these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A critical review of self-management and educational interventions in inflammatory bowel disease. Barlow, C., Cooke, D., Mulligan, K., et al.[2022]

A systematic review of six studies on self-management interventions for adults with inflammatory bowel disease (IBD) found that most interventions included two of the five key self-management skills, with one intervention incorporating all five skills.

Four studies showed that self-management positively affected disease activity, while two interventions improved disease-specific health-related quality of life (HRQOL), highlighting the potential benefits of self-management strategies in managing IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Self-Management Interventions for Inflammatory Bowel Disease. Conley, S., Redeker, N.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Self-Efficacy and the Impact of Inflammatory Bowel Disease on Patients' Daily Lives. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of TELEmedicine for Inflammatory Bowel Disease on Patient Activation and Self-Efficacy. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A critical review of self-management and educational interventions in inflammatory bowel disease. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Supported online self-management versus care as usual for symptoms of fatigue, pain and urgency/incontinence in adults with inflammatory bowel disease (IBD-BOOST): study protocol for a randomised controlled trial. [2023]

5. Ireland pubmed.ncbi.nlm.nih.gov

Review and content analysis of mobile apps for inflammatory bowel disease management using the mobile application rating scale (MARS): Systematic search in app stores. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Self-Management Interventions for Inflammatory Bowel Disease. [2022]