Self-Management Program for Inflammatory Bowel Disease

Overseen By Kindra Clark-Snustad, DNP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Live outside Washington, Recent bowel surgery

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

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

54 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to test the feasibility, acceptability, and preliminary efficacy of a comprehensive self-management (CSM) intervention for people with inflammatory bowel disease (IBD). The CSM-IBD intervention is an adaption of the CSM intervention initially developed for individuals with irritable bowel syndrome. The intervention has eight sessions which cover an introduction to IBD, symptom tracking, cognitive behavioral strategies, relaxation, sleep, diet, and pain management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Comprehensive Self-Management Intervention for Inflammatory Bowel Disease?

The Comprehensive Self-Management Intervention has been effective for patients with irritable bowel syndrome, which shares similar symptoms with inflammatory bowel disease. This suggests it might also help people with inflammatory bowel disease manage their symptoms better. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Comprehensive Self-Management Intervention for Inflammatory Bowel Disease?

The Comprehensive Self-Management Intervention has been effective for patients with irritable bowel syndrome, which shares similar symptoms with inflammatory bowel disease. This suggests it may also help people with IBD manage their symptoms better. ^{1 2 3 4 5}

Is the Comprehensive Self-Management Intervention safe for humans?

The available research does not specifically address safety concerns for the Comprehensive Self-Management Intervention, but it has been used in studies for irritable bowel syndrome and inflammatory bowel disease without reported safety issues. ^{1 2 4 5 6}

Is the Comprehensive Self-Management Intervention safe for humans?

The available research does not specifically address safety concerns for the Comprehensive Self-Management Intervention, but it has been used in similar conditions like irritable bowel syndrome without reported safety issues. ^{1 2 4 5 6}

How is the Comprehensive Self-Management Intervention (CSM-IBD) treatment different from other treatments for inflammatory bowel disease?

The Comprehensive Self-Management Intervention (CSM-IBD) is unique because it focuses on nonmedical self-management strategies, combining cognitive behavioral therapy (a type of talk therapy) with relaxation and dietary strategies, tailored specifically for people with inflammatory bowel disease. This 8-session program is delivered over 8-12 weeks with support from a registered nurse, aiming to help patients manage symptoms like abdominal pain and fatigue, which are not typically addressed by standard medical treatments. ^{1 2 3 5 6}

How is the Comprehensive Self-Management Intervention (CSM-IBD) treatment different from other treatments for inflammatory bowel disease?

The Comprehensive Self-Management Intervention (CSM-IBD) is unique because it focuses on helping patients manage their condition through an 8-session program that includes check-ins with a nurse, rather than relying solely on medication. This approach is adapted from a successful program for irritable bowel syndrome and aims to address symptoms like abdominal pain and anxiety by teaching self-management skills. ^{1 2 3 5 6}

Research Team

Kendra Kamp, PHD, RN

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for English-speaking individuals with a healthcare provider's diagnosis of inflammatory bowel disease (IBD), including Crohn's Disease and Ulcerative Colitis, who are currently experiencing symptoms. It's not open to those living outside Washington state or anyone who has had bowel-related surgery in the past month.

Inclusion Criteria

My doctor diagnosed me with inflammatory bowel disease.

I can describe my current health symptoms.

Able to read and write in English

Exclusion Criteria

Live outside of Washington state

I have had surgery related to my bowels in the last month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week comprehensive self-management intervention delivered online with weekly check-ins

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (virtual)

Treatment Details

Interventions

• Comprehensive Self-Management Intervention

Trial Overview The study tests a Comprehensive Self-Management (CSM) program adapted from one for irritable bowel syndrome. Over eight sessions, it covers IBD education, symptom tracking, cognitive strategies, relaxation techniques, sleep improvement tips, dietary guidance, and pain management.

Participant Groups

Group I: Usual care group Experimental Treatment 1 Intervention

The control group will receive standard care without the comprehensive self-management intervention.

Group II: Comprehensive Self-Management Experimental Treatment 1 Intervention

The 8 week intervention is delivered online with a brief weekly check-in with a registered nurse.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Findings from Research

The pilot study is testing a modified comprehensive self-management intervention (CSM-IBD) for individuals with inflammatory bowel disease (IBD), aiming to improve quality of life and manage symptoms over 8 sessions within 8-12 weeks, with initial recruitment showing 4 participants enrolled as of April 2023.

The study will assess the feasibility and acceptability of the CSM-IBD program, with the goal of validating a self-management approach that is culturally appropriate and accessible, particularly for rural and underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comprehensive Self-Management Intervention for Inflammatory Bowel Disease (CSM-IBD): Protocol for a Pilot Randomized Controlled Trial. Kamp, K., Clark-Snustad, K., Yoo, L., et al.[2023]

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]

The 'flare card' self-management tool was positively received by patients with inflammatory bowel disease (IBD), helping them feel more in control of their condition and improving medication adherence and symptom management.

Over a 10-month period, patients using the 'flare card' showed a significant reduction in both IBD and non-IBD service usage, as well as decreased steroid prescriptions and unscheduled IBD care, indicating its effectiveness in optimizing care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a self-management strategy in inflammatory bowel disease (IBD): patient perceptions, clinical outcomes and the impact on service. Squires, SI., Boal, AJ., Lamont, S., et al.[2020]

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 comprehensive self-management program combining cognitive behavioral therapy, relaxation techniques, and dietary strategies significantly reduced gastrointestinal symptoms and improved quality of life in patients with irritable bowel syndrome (IBS) over a 13-week period.

One year after completing the program, 94% of participants continued to use at least six strategies from the program, demonstrating lasting behavioral changes and high adherence rates across all strategy categories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comprehensive Self-Management Irritable Bowel Syndrome Program Produces Sustainable Changes in Behavior After 1 Year. Zia, JK., Barney, P., Cain, KC., et al.[2018]

A systematic review of nine trials involving children and adolescents with inflammatory bowel disease (IBD) found that self-management interventions showed some benefits in areas like disease activity and medication adherence, but results were inconsistent and many studies were underpowered, with most having fewer than 50 participants.

There is a need for clinical consensus on effective self-management strategies for IBD in young patients, as well as adequately powered trials to better understand how to support their self-management effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Self-Management Interventions for Children and Adolescents With Inflammatory Bowel Disease. Tran, L., Mulligan, K.[2020]

References

1. Canada pubmed.ncbi.nlm.nih.gov

A Comprehensive Self-Management Intervention for Inflammatory Bowel Disease (CSM-IBD): Protocol for a Pilot Randomized Controlled Trial. [2023]

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

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

3. England pubmed.ncbi.nlm.nih.gov

Implementing a self-management strategy in inflammatory bowel disease (IBD): patient perceptions, clinical outcomes and the impact on service. [2020]

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

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

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

A Comprehensive Self-Management Irritable Bowel Syndrome Program Produces Sustainable Changes in Behavior After 1 Year. [2018]

6. England pubmed.ncbi.nlm.nih.gov

A Systematic Review of Self-Management Interventions for Children and Adolescents With Inflammatory Bowel Disease. [2020]