Peer Support for Inflammatory Bowel Disease Distress

Overseen By Natalie Willett, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jennifer Jones

Disqualifiers: Severe psychological pathology, Bipolar, Schizophrenia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online peer support program, IBD Strong Peer2Peer, designed to help adults with inflammatory bowel disease (IBD) manage stress and emotional challenges. The researchers aim to determine if this program can improve mental health and access to care for those experiencing IBD-related distress. Participants will either receive the intervention or be placed on a waitlist. Adults with IBD facing changes such as a new diagnosis, medication adjustments, or upcoming surgery might be suitable for this trial. As an unphased trial, it offers a unique opportunity to explore innovative support methods for managing IBD-related challenges.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants can be in a period of changing medications, so it might be possible to continue your current treatment.

What prior data suggests that this intervention is safe for individuals with IBD?

Research has shown that peer support programs, such as the IBD Strong Peer2Peer intervention, successfully help teenagers manage their conditions. However, specific safety data for this type of peer support is not available. As a psychological intervention rather than a medication, it does not involve drug-related side effects. Peer support is generally considered safe and is often well-received, as it emphasizes emotional and social support over medical treatments. It aims to help individuals feel more connected and less stressed about managing their condition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the IBD Strong Peer2Peer intervention because it offers a unique approach to managing distress in individuals with inflammatory bowel disease (IBD). Unlike standard treatments that often focus on medication and lifestyle changes to manage physical symptoms, this intervention emphasizes emotional and social support. By connecting patients with peers who understand their experiences, the program aims to provide mental and emotional relief, which is often overlooked in traditional IBD care. This peer support model could enhance overall well-being and improve the quality of life for those living with IBD.

What evidence suggests that the IBD Strong Peer2Peer intervention is effective for IBD-related psychological distress?

Research has shown that the IBD Strong Peer2Peer program, which participants in this trial may receive, could help people with inflammatory bowel disease (IBD) cope with stress. A previous study found that a similar program, iPeer2Peer, helped teenagers manage their condition better by offering support from peers. This method has now been adapted for adults, providing emotional support and teaching stress management techniques. Peer support has proven effective in helping people manage their condition and build emotional strength. These findings suggest that the IBD Strong Peer2Peer program could effectively reduce stress and improve the quality of life for people with IBD. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Inflammatory Bowel Disease (IBD) who are newly diagnosed, switching from child to adult care, experiencing a flare-up or medication change, recently hospitalized, or preparing for surgery. It's not suitable for those outside these criteria.

Inclusion Criteria

I am 18 or older with inflammatory bowel disease.

I am newly diagnosed or currently adjusting my care or treatment plan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the IBD Strong Peer intervention, a peer-led, virtually administered program for managing psychological distress

8 weeks

Virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IBD Strong Peer2Peer

Trial Overview The IBD Strong Peer2Peer program is being tested against a waitlist control group. This peer-led virtual support aims to help manage psychological distress in adults with IBD. The study will gather data on how well it works and how it can be improved.

How Is the Trial Designed?

Group I: Waitlist -controls Experimental Treatment 1 Intervention

Group II: IBD Strong Peer2Peer intervention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Jennifer Jones

Lead Sponsor

Trials

3

Recruited

300+

Crohn's and Colitis Canada

Collaborator

Trials

8

Recruited

1,300+

Nova Scotia Health Authority

Collaborator

Trials

302

Recruited

95,300+

Published Research Related to This Trial

The prevalence of inflammatory bowel disease (IBD) is rising among older adults, particularly those over 60, yet this group is often underrepresented in clinical trials, leading to inconsistent care and high rates of corticosteroid use.

Effective management of IBD in older adults requires a personalized approach that considers individual risks, comorbidities, and the need for better research on treatment efficacy and safety tailored to this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of inflammatory bowel diseases in older adults. Singh, S., Boland, BS., Jess, T., et al.[2023]

A systematic review of 14 studies on peer support interventions for people with inflammatory bowel diseases (IBD) found no significant evidence that these interventions improve quality of life or psychosocial outcomes, indicating a need for more focused research.

Most studies included peer support as part of broader interventions, making it difficult to isolate its specific effects; future randomized controlled trials should aim to evaluate peer support independently to better understand its potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer support for carers and patients with inflammatory bowel disease: a systematic review. Adriano, A., Thompson, DM., McMullan, C., et al.[2022]

The IBD Connect program, which involves peer volunteers providing emotional support to hospitalized patients with inflammatory bowel disease (IBD), has successfully made 1469 visits to 677 patients since its launch in 2012, demonstrating its feasibility and positive reception.

Patients reported a significant decrease in stress related to hospitalization and an increased willingness to share their IBD experiences with family and friends, highlighting the importance of peer support in enhancing patient-centered care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inflammatory Bowel Disease (IBD) Connect: A Novel Volunteer Program for Hospitalized Patients with IBD and Their Families. Hashash, JG., Sigal, R., Wein-Levy, P., et al.[2019]

In a study of 2906 individuals with potential inflammatory bowel disease (IBD) diagnoses from computerized data, 81% were confirmed to have IBD through chart review, indicating a high level of accuracy in the computerized data.

By requiring two or more visits for diagnosis, the positive predictive value (PPV) of identifying true IBD cases increased to 95%, demonstrating that computerized data can be reliably used for research on drug safety and treatment efficacy in IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity of computerized diagnoses, procedures, and drugs for inflammatory bowel disease in a northern California managed care organization. Liu, L., Allison, JE., Herrinton, LJ.[2022]

Out of 2084 patients with inflammatory bowel disease (IBD) invited to join a self-help group, only 138 (7%) actually joined, with higher participation rates among women and those with Crohn's disease.

Respondents indicated that the self-help group was valuable for providing information, mutual support, and opportunities to discuss issues, with 99% finding the general information useful, although many non-joiners cited reasons like being too busy or managing without support as barriers to participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disinterest in local self-help groups amongst patients with inflammatory bowel disease in Leicester. Moody, GA., Bhakta, P., Mayberry, JF.[2019]

In a study of 1032 IBD patients in Germany, about one-third were not in clinical remission, highlighting a significant burden of active disease despite high rates of immunosuppressive drug use.

The study found that 15% of patients reported depressive symptoms and 21% experienced impairments in sexuality, indicating that IBD is associated with considerable psychosocial challenges alongside physical health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical status, psychosocial impairments, medical treatment and health care costs for patients with inflammatory bowel disease (IBD) in Germany: an online IBD registry. Bokemeyer, B., Hardt, J., Hüppe, D., et al.[2016]

Peer support interventions for adolescents and young adults (AYAs) with inflammatory bowel disease (IBD) are promising and can enhance self-management, but there is currently limited research on this topic, with only two studies identified.

An innovative mobile-based peer coaching program was developed, demonstrating the potential to effectively support AYAs with IBD in managing their condition and promoting positive behavioral changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Application of a Peer Coaching Intervention to Enhance Self-Management for Adolescents and Young Adults With Inflammatory Bowel Disease. Pollock, MD., Brotkin, SM., Denio, E., et al.[2023]

In a study of 408 inflammatory bowel disease (IBD) patients, those living closer to specialist centers (within 10 km) received more aggressive treatments, such as anti-TNF agents and corticosteroids, compared to those living further away (over 35 km).

Despite differences in treatment based on distance to specialists, the overall disease course and need for surgeries did not vary significantly among the different distance groups, suggesting that while access may influence treatment choices, it does not necessarily impact long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of distance to specialist care for the diagnosis and disease outcome of inflammatory bowel disease in the Swiss inflammatory bowel disease cohort study. Grob, L., Bluemel, S., Biedermann, L., et al.[2022]

In a study of pediatric patients with ulcerative colitis (UC) and Crohn's disease (CD) over 3 years, the use of corticosteroids decreased while the use of anti-TNF biologics and other immunosuppressants increased, indicating a shift towards more targeted therapies.

The initial maintenance doses of biologics like infliximab and adalimumab were found to be significantly higher than standard dosing guidelines, suggesting a need for further evaluation of dosing practices in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment and biologic maintenance-dosing patterns among pediatric patients with ulcerative colitis or Crohn's disease. Hunter, T., Komocsar, WJ., Colletti, RB., et al.[2023]

A peer mentoring program for youth with inflammatory bowel disease (IBD) was developed based on focus group feedback from 36 participants, including youth and parents, emphasizing the importance of support, role modeling, and education.

The proposed program includes a year-long, one-on-one mentoring relationship with peers who have IBD, along with educational and fun activities, which aligns with successful mentoring practices and aims to enhance self-management skills in pediatric IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focus groups for developing a peer mentoring program to improve self-management in pediatric inflammatory bowel disease. Mackner, LM., Ruff, JM., Vannatta, K.[2021]

In a study of 95 patients over 65 years old with inflammatory bowel disease (IBD) treated with TNF inhibitors, 11% experienced severe infections and 10% died, indicating a higher risk compared to younger patients.

The findings suggest that older patients on TNF inhibitors have a significantly increased rate of severe infections and mortality compared to both younger patients and older patients treated with other medications, highlighting the need for further research on the safety of these therapies in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced age is an independent risk factor for severe infections and mortality in patients given anti-tumor necrosis factor therapy for inflammatory bowel disease. Cottone, M., Kohn, A., Daperno, M., et al.[2022]

Participation in online support communities for inflammatory bowel disease (IBD) significantly enhances patients' access to information and emotional support, helping them manage their condition and improve their overall wellbeing.

While these communities offer valuable benefits, such as fostering a positive outlook on illness, they also have limitations that healthcare professionals should recognize when advising patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do online patient support communities affect the experience of inflammatory bowel disease? An online survey. Coulson, NS.[2022]

The Crohn's and Colitis Foundation of America Partners Patient-Powered Research Network (PPRN) aims to enhance research in inflammatory bowel diseases (IBDs) by utilizing patient-generated health data to inform and prioritize research agendas.

This network has established a community of 'citizen scientists' and developed a robust infrastructure to facilitate patient engagement in research, ultimately aiming to improve health outcomes for individuals with IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harnessing person-generated health data to accelerate patient-centered outcomes research: the Crohn's and Colitis Foundation of America PCORnet Patient Powered Research Network (CCFA Partners). Chung, AE., Sandler, RS., Long, MD., et al.[2022]

A pilot study involving 15 participants showed that using patient-reported outcomes measures (PROMs) through an electronic platform for self-management in IBD care was well-accepted, with 10 participants feeling 'well' or 'well with questions'.

The implementation of PROMs in outpatient settings allowed for real-time tracking of quality of life and disease activity, enabling remote management of well patients and potentially increasing efficiency in outpatient services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using e-health tools and PROMs to support self-management in patients with inflammatory bowel disease. Avery, P.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11657413/

Bolstering connectedness through peer support The study aimed to capture whether a peer mentoring program (iPeer2Peer©) was successful at improving adolescent disease self-management.

2. studies.bethecure.ca studies.bethecure.ca/find/abe867b16e941f4198be16eb5558615b834f91aa-a-randomized-wait-list-controlled-clinical-tria?locale=fr

Inflammatory Bowel Diseases Using qualitative data derived from an extensive stakeholder engagement process, iPeer2Peer has been adapted to meet the needs of adults living with IBD-PD.

3. withpower.com withpower.com/trial/phase-intestinal-diseases-2-2023-61229

Peer Support for Inflammatory Bowel Disease Distress Yes, IBD Strong Peer2Peer is a promising treatment for people with inflammatory bowel disease. It offers emotional support and helps people learn coping ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1542356524009637

Multidimensional Patient-Reported Outcomes and Quality ... We found a substantial patient-reported disease burden in newly diagnosed IBD, underscoring the importance of vigilant PRO monitoring in clinical practice.

5. academic.oup.com academic.oup.com/ibdjournal/article/31/Supplement_1/S65/7978451

IBD RISE (RESILIENCE, INFORMATION, SUPPORT, AND ... This study underscores the role of peer support in improving disease management and emotional resilience, with strong potential for broader ...

6. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05722236?keyword=%22Mentoring%22

IBD Strong Peer2Peer for Self-Management of Psychological ... Using qualitative data derived from an extensive stakeholder engagement process, iPeer2Peer has been adapted to meet the needs of adults living with IBD-PD.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3767062/

How do online patient support communities affect the ... This study therefore surveyed 249 patients living with inflammatory bowel disease (IBD) about their online support community experiences including reasons for ...

8. mdpi.com mdpi.com/2227-9067/11/12/1492

Patient-Reported Outcomes Measurement Information ... Data on PROs in pediatric IBD are emerging [22,32,62,68,69]. These studies, which use several PROMIS pediatric measures, consistently document similar results ...