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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different self-help tools can empower people with Crohn's disease and other inflammatory bowel diseases to better manage their condition. It aims to identify which tools, such as a book, an app, a help center, or a peer mentor, can reduce the daily challenges caused by IBD. Participants will be divided into groups to test these resources, collectively called EMPOWER-IBD Interventions. Adults who have experienced moderate-to-severe daily difficulties due to IBD and can use smartphone apps might be a good fit. As an unphased trial, this study offers a unique opportunity for patients to contribute to innovative approaches in managing IBD.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the self-help tools in this trial are generally safe for people with Crohn's disease.

The Power of Two (PEER) program, a peer mentoring service run by the Crohn's & Colitis Foundation, has no evidence of harmful effects. It emphasizes support and connection between patients, making it well-received.

The IBD Help Center (HELP), another resource from the Crohn's & Colitis Foundation, provides information and guidance without any known safety concerns.

The "Coping with Crohn's and Colitis" workbook employs cognitive behavioral therapy (CBT). Studies have shown that CBT can improve mental health in people with IBD and is considered safe.

Lastly, the My IBD Care app helps users track symptoms and manage their condition. It has received positive reviews for quality and has not been linked to any safety issues.

Overall, these tools are non-invasive and focus on support and education. They aim to help manage the condition rather than directly treat it, making them low-risk in terms of safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EMPOWER-IBD interventions because they offer a fresh approach to managing Crohn's Disease through self-help techniques, rather than traditional medication alone. Unlike typical treatments that focus directly on inflammation, these interventions emphasize psychological and social support. For instance, the Power of Two (PEER) program provides one-on-one peer mentoring, while the IBD Help Center offers personalized guidance via various communication methods. Additionally, the integration of cognitive behavioral therapy (CBT) through a specialized workbook and the use of the My IBD Care app for symptom tracking and self-paced behavioral change set these treatments apart by empowering patients to take an active role in managing their condition.

What evidence suggests that this trial's treatments could be effective for reducing IBD-related disability?

This trial will evaluate various self-help interventions for Crohn's Disease. Research has shown that peer support programs, such as the Power of Two (PEER), one of the interventions in this trial, can help people with inflammatory bowel disease (IBD) manage their condition better and build emotional strength. Another intervention, the IBD Help Center (HELP), reduced urgent care visits by 51% with its Urgent Care Toolkit, highlighting the benefits of access to helpful information and resources. Cognitive Behavioral Therapy (CBT) for IBD, featured in the "Coping with Crohn's and Colitis" workbook, is also being tested in this trial and has enhanced quality of life while reducing anxiety and depression in patients. Additionally, the My IBD Care app, another intervention in this trial, assists users in managing symptoms and tracking medical information, earning high ratings for quality and usefulness. Together, these tools and programs show promise in helping individuals handle the challenges associated with IBD. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8672154/

The physiological and psychological effects of cognitive ... CBT was shown to improve patient's quality of life and reduce the level of depression and anxiety post-intervention but was not sustained.

2. journals.lww.com journals.lww.com/ajg/fulltext/9900/inflammatory_bowel_diseases_specific_cognitive.1863.aspx

Inflammatory Bowel Diseases-Specific Cognitive ... Coping With Crohn's and Colitis: A Patient and Clinician's Guide to CBT for IBD. New York City: Routledge; 2021. Cited Here. 20. Hunt MG. CBT ...

3. researchgate.net researchgate.net/publication/355309007_Coping_with_Crohn's_and_Colitis_A_Patient_and_Clinician's_Guide_to_CBT_for_IBD

A Patient and Clinician's Guide to CBT for IBD - Colitis Psychological therapies such as cognitive behavioral therapy (CBT) and hypnotherapy have demonstrated effectiveness in multiple studies for patients ...

4. amazon.com amazon.com/Coping-Crohns-Colitis-Melissa-Hunt/dp/0367523671

Coping with Crohn's and Colitis: A Patient and Clinician's ... This practical guide provides patients who have inflammatory bowel disease (IBD) with cognitive-behavioral therapy (CBT) strategies for coping with IBD.

5. bmjopengastro.bmj.com bmjopengastro.bmj.com/content/3/1/e000071

Effectiveness of disease-specific cognitive–behavioural ... The present multicentre randomised controlled trial aims to test the effectiveness of an IBD-specific cognitive–behavioural therapy (CBT) protocol in reducing ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10971081/

Coping Strategies and Inflammatory Bowel Disease Patients with Crohn's disease (CD) experienced a greater degree of psychological impairments in comparison to individuals with ulcerative colitis (UC) or the ...

7. crohnsandcolitis.org.uk crohnsandcolitis.org.uk/info-support/information-about-crohns-and-colitis/all-information-about-crohns-and-colitis/living-with-crohns-or-colitis/mental-health-and-wellbeing

Mental health and wellbeing with Crohn's or Colitis You're most at risk of depression when your Crohn's or Colitis symptoms are worse. As well as the stress and worry of dealing with symptoms, inflammation in ...

8. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/1471-244X-12-227

The effectiveness of cognitive behavioral therapy on the ... Inflammatory Bowel Disease (IBD) patients report poorer quality of life (QoL) and more anxiety and depressive symptoms than controls from ...