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.
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.
12345Is 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.
12456How 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.
12356Eligibility 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.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Usual care groupExperimental Treatment1 Intervention
The control group will receive standard care without the comprehensive self-management intervention.
Group II: Comprehensive Self-ManagementExperimental Treatment1 Intervention
The 8 week intervention is delivered online with a brief weekly check-in with a registered nurse.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of WashingtonSeattle, WA
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Who Is Running the Clinical Trial?
University of WashingtonLead Sponsor
National Institute of Nursing Research (NINR)Collaborator
References
A Comprehensive Self-Management Intervention for Inflammatory Bowel Disease (CSM-IBD): Protocol for a Pilot Randomized Controlled Trial. [2023]Despite pharmacological treatment, individuals with inflammatory bowel disease (IBD) experience a variety of symptoms, including abdominal pain, fatigue, anxiety, and depression. Few nonmedical self-management interventions are available for people with IBD. A validated comprehensive self-management (CSM) intervention is effective for patients with irritable bowel syndrome who can have symptoms similar to those of individuals with IBD. We created a modified CSM intervention tailored to individuals with IBD (CSM-IBD). The CSM-IBD is an 8-session program delivered over 8-12 weeks with check-ins with a registered nurse.
A Systematic Review of Self-Management Interventions for Inflammatory Bowel Disease. [2022]To conduct a systematic review of self-management interventions for adults with inflammatory bowel disease (IBD) to (a) describe self-management skills in the interventions and (b) describe the effects of the interventions on the health-related outcomes measured.
Implementing a self-management strategy in inflammatory bowel disease (IBD): patient perceptions, clinical outcomes and the impact on service. [2020]Patient self-management and its service integration is not a new concept but it may be a key component in the long-term sustainability of inflammatory bowel disease (IBD) service provision, when considering growing disease prevalence and limited resources.
A critical review of self-management and educational interventions in inflammatory bowel disease. [2022]The purpose of this study was to examine self-management and educational interventions developed to support people with inflammatory bowel disease (IBD) and to identify which type of intervention seems to be most effective. The search was deliberately overinclusive to capture studies that evaluated educational and self-management interventions. The following databases were searched: MEDLINE, Embase, CINAHL, PsycINFO, the National Research Register, and Cochrane. Twenty-three studies were included. Thirteen of these were randomized controlled trials. The content of the interventions reviewed varied widely. As expected, it is the three studies that have explicitly labeled themselves as self-management interventions that have incorporated the greatest number of self-management techniques. Two of these studies reported the greatest number of improved outcomes in relation to symptom reporting, psychological well-being, and healthcare resource use. There is clearly a role for information in IBD, but this review supports research in other conditions that shows that education cannot be assumed to lead to improvements in health and well-being. Much of the research in this area focuses on education rather than self-management. Where self-management techniques have been applied, the findings tend to be more promising. Gastroenterology nurses (or in the United Kingdom, IBD specialist nurses) may be best placed to facilitate self-management in this group.
A Comprehensive Self-Management Irritable Bowel Syndrome Program Produces Sustainable Changes in Behavior After 1 Year. [2018]We developed a comprehensive self-management (CSM) program that combines cognitive behavioral therapy with relaxation and dietary strategies; 9 sessions (1 hour each) over 13 weeks were shown to reduce gastrointestinal symptoms and increase quality of life in a randomized trial of patients with irritable bowel syndrome (IBS), compared with usual care. The aims of this study were to describe strategies patients with IBS selected and continued to use, 12 months after the CSM program began.
A Systematic Review of Self-Management Interventions for Children and Adolescents With Inflammatory Bowel Disease. [2020]Self-management of inflammatory bowel disease is complex. Children and adolescents (CA) with inflammatory bowel disease (IBD) often have difficulty with managing aspects of their condition, resulting in treatment nonadherence and impaired psychosocial function. Self-management interventions are developed to help support patients and their parents/carers to effectively self-manage. The aim of this systematic review was to evaluate the efficacy of self-management interventions in children and adolescents with IBD.