A Comprehensive Self-Management Intervention for Individuals With Inflammatory Bowel Disease
Phase: NA
Conditions: Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
Sponsor: University of Washington

Title: A Comprehensive Self-Management Intervention for Individuals with Inflammatory 
Bowel Disease 
NCT Number: NCT05651542 
Unique Protocol Id: STUDY00015210 
Document Last Updated Date: May 2023 
 
 
Source:  
Kamp K, Clark-Snustad K, Yoo L, Winders S, Cain K, Levy R, Dey N, Lee S, Keefer L, 
Heitkemper M A Comprehensive Self-Management Intervention for Inflammatory Bowel 
Disease (CSM-IBD): Protocol for a Pilot Randomized Controlled Trial JMIR Res Protoc 
2023;12:e46307  
URL: https://www.researchprotocols.org/2023/1/e46307 
DOI: 10.2196/46307 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Abstract 
Background: 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. 
Objective: The primary objective of this pilot study is to determine the feasibility and 
acceptability of study procedures and the CSM-IBD intervention and to evaluate preliminary 
efficacy on quality of life and daily symptoms for a future randomized controlled trial. 
Additionally, we will examine the association of socioecological, clinical, and biological factors 
with symptoms at baseline and response to intervention. 
Methods: We are conducting a pilot randomized controlled trial of the CSM-IBD intervention. 
Participants aged 18-75 years who are experiencing at least 2 symptoms are eligible for 
inclusion. We plan to enroll 54 participants who will be randomized (2:1) into the CSM-IBD 
program or usual care. Patients in the CSM-IBD program will have 8 intervention sessions. 
Primary study outcomes include the feasibility of recruitment, randomization, and data or sample 
collection, as well as the acceptability of study procedures and interventions. Preliminary 
efficacy outcome variables include quality of life and symptoms. Outcomes data will be assessed 
at baseline, immediately post intervention, and 3 months post intervention. Participants in the 
usual care group will have access to the intervention after study participation. 
Results: This project is funded by the National Institutes of Nursing Research and reviewed by 
the University of Washington’s institutional review board. Recruitment began in February 2023. 
As of April 2023, we have enrolled 4 participants. We expect the study to be completed by 
March 2025. 
Conclusions: This pilot study will evaluate the feasibility and efficacy of a self-management 
intervention (a web-based program with weekly check-ins with a registered nurse) that aims to 
improve symptom management in individuals with IBD. In the long term, we aim to validate a 
self-management intervention to improve patient quality of life, reduce direct and indirect costs 
related to IBD, and be culturally appropriate and accessible, particularly in rural and underserved 
communities. 
Trial Registration:ClinicalTrials.gov NCT05651542; 
https://clinicaltrials.gov/ct2/show/NCT05651542 
International Registered Report Identifier (IRRID):PRR1-10.2196/46307 
 

Introduction 
Background and Rationale 
Inflammatory bowel disease (IBD; including ulcerative colitis and Crohn disease) is a chronic 
immune-mediated disease of the gastrointestinal system that impacts individuals worldwide. 
Patients with IBD are often diagnosed at a young age and experience a lifetime of disease 
management, with symptoms including diarrhea, pain, fatigue, urgency, anxiety, and depression 
[1,2]. These symptoms result in suffering, substantial health care costs, and indirect costs related 
to work and school impairment, with fatigue being the most common reason for work 
absenteeism [3]. Health care providers are often not trained to manage noninflammatory 
symptoms, and with improved medications such as biologics and small molecule therapy, the 
disconnect between patient symptoms and management is widening [4,5]. Our team has a 
comprehensive solution to help patients with irritable bowel syndrome manage symptoms and 
improve self-management skills that can be adapted for an IBD population to address the urgent 
need for symptom management. 
Within the United States, approximately 3.1 million individuals have a diagnosis of IBD [6]. As 
societies become more westernized, IBD incidence and prevalence have increased worldwide 
[7]. IBD affects men and women equally, although ulcerative colitis is slightly more common in 
males and Crohn disease is slightly more frequent in females [8]. In the past, it was thought that 
IBD occurred less frequently in racial and ethnic minorities compared with whites; however, this 
gap is narrowing with an increased incidence of IBD among African American and Asian 
individuals [9]. Therefore, with growing incidence and prevalence worldwide and among racial 
and ethnic minority populations, IBD represents a growing health problem demanding tailored, 
culturally appropriate, and effective interventions. 
Immunosuppressive therapy can be effective in achieving control of endoscopic inflammation 
from IBD; yet, patients can experience symptoms while they await response to therapy or in the 
setting of refractory disease [10,11]. Patients can also have chronic symptoms, even after 
achieving remission, due to damage from chronic disease, altered surgical anatomy, or co-
occurring functional symptoms [12]. While immunosuppression is essential in achieving and 
maintaining endoscopic remission for patients with moderate-severe IBD, other interventions are 
needed to improve symptom management and quality of life. 
Symptom-directed medical therapies (eg, antidiarrheals, antiemetics, antispasmodics, and 
neuromodulators) offer symptom relief for some but are not effective for everyone and offer 
limited benefit for symptoms such as pain and fatigue. Nonpharmacological interventions such 
as dietary modification, relaxation techniques, and cognitive behavioral therapy (CBT) have 
been shown to improve symptoms [13,14], but teaching patients how to implement these 
interventions is time-consuming and impractical to achieve in a routine clinic visit. Some clinics 
have used an IBD specialty medical home model, which can reduce hospitalizations and 
emergency department visits as well as increase the quality of life [15]. Yet, patient access to 

providers who are experienced in these interventions and care delivery systems can be limited, 
especially in rural and underserved communities [16,17]. 
As the majority of a patient’s time is spent outside of the clinic, there is a need to empower 
patients with the skills to manage their disease. Self-management refers to the day-to-day 
management that individuals must engage in while living with a chronic condition [18,19]. 
Among individuals with other chronic conditions, self-management programs are effective in 
reducing hospitalizations, days in the hospital, and fatigue while increasing self-reported health 
[20,21]. Despite the effectiveness of self-management programs among other chronic condition 
populations, few effective self-management interventions exist for individuals with IBD [22]. A 
systematic review identified 6 self-management randomized controlled trials conducted among 
individuals with IBD (representing 1715 patients) [22]. However, only half of the interventions 
improved health-related quality of life or reduced disease activity at 12 months. Psychological 
outcomes were reported by 2 studies, and 1, which used a written self-management plan 
developed with a clinician, failed to demonstrate an improvement in depression and anxiety 
[23,24]. 
An existing comprehensive self-management (CSM) intervention that provides patient education 
on nonmedical interventions for symptom management (eg, dietary modification, stress 
reduction, and CBT) has been shown to improve quality of life and decrease abdominal pain in 
patients with irritable bowel syndrome [25-27]. Furthermore, the intervention reduced anxiety, 
depression, fatigue, and extraintestinal pain and improved self-reported sleep compared to usual 
care [28,29]. To date, CSM interventions have not been routinely used in patients with IBD. 
Because there is a significant overlap between symptoms of irritable bowel syndrome and those 
of IBD, we hypothesized that adapting the CSM intervention to a population of individuals with 
IBD may also be effective (CSM-IBD). However, this remains to be tested. 
Objectives 
The objectives of this pilot randomized controlled trial are to (1) determine the feasibility and 
acceptability of study procedures (recruitment, randomization, and data and sample collection) 
and CSM-IBD; (2) compare CSM-IBD to usual care on changes from baseline to 3 months post 
intervention in quality of life and daily symptoms (fatigue, sleep disturbance, psychological 
distress, gastrointestinal symptoms) among IBD patients and (3) explore the association of 
socioecological factors (age, sex, race, ethnicity, or diet), clinical phenotype (medications, 
disease distribution, and disease activity), and biological signatures (microbiome and 
calprotectin) with symptoms at baseline and response to intervention (post intervention). 
 
 
 
 

Methods 
Study Design 
The proposed study is a 2-arm pilot randomized controlled trial that follows the Consolidated 
Standards of Reporting Trials and Standard Protocol Items: Recommendations for Interventional 
Trials guidelines [30,31]. In a 2:1 ratio, 54 participants will be randomized (intervention=36 
participants; usual care=18 participants). This randomization scheme was selected to maximize 
data collection and information regarding the intervention group. The intervention will take place 
over 8 sessions. The participants will be blinded to the study hypotheses. Web-based self-
reported questionnaires will be used to reduce detection bias. 
Theoretical Framework 
This study is guided by the Individual and Family Self-Management Theory (IFSMT) [32]. The 
IFSMT has 3 dimensions: context, process, and outcomes. It posits that interventions can 
influence the context and process (Figure 1). The context includes not only the individuals with 
IBD but also the complexity of the condition or treatment, individual factors (eg, age and sex), 
and social determinants of health such as food access and environmental settings, which can 
influence self-management skills and the ability to self-manage. In the IFMST, the process 
includes knowledge and beliefs (patient activation), self-regulation skills and abilities, and social 
facilitation and support (see Table 1 for the IFSMT process and CSM-IBD content). The IFSMT 
process of knowledge and beliefs includes Bandura self-efficacy theory, in which the 
intervention enhances self-efficacy (an individual’s belief in their capacity to execute behaviors) 
and thus improves self-management [33,34]. Specific strategies and approaches used within the 
intervention are based on the expansive literature on CBT [35,36]. By impacting both the context 
and process, the intervention can influence the outcome to decrease symptoms and improve 
quality of life. 
Figure 1. Individual and Family Self-Management Theory. 

Table 1. IFSMTa self-management processes and CSM-IBDb content. 
IFSMT process 
IFSMT description 
CSM-IBD content 
Knowledge and beliefs 
 
Factual information 
 
Self-efficacy 
 
Goal congruence 
 
“When to contact your provider” 
 
Introduction to strategies 
 
Explanation of self-management 
 
Personalized goals 
Self-regulation skills and 
abilities 
 
Goal-setting, self-monitoring, 
reflective thinking 
 
Decision-making, planning and 
action 
 
Self-evaluation 
 
Patient activation 
 
Abdominal breathing 
 
Alternative thinking 
 
Passive or active progressive muscle 
relaxation 
 
Cognitive distortions 
 
Sleep patterns, sleep hygiene 
 
Pain management 
Social facilitation 
 
Social influence 
 
Support 
 
Eating out 
 
Travel 
aIFSMT: Individual and Family Self-Management Theory. 
bCSM-IBD: comprehensive self-management for inflammatory bowel disease. 

Study Population 
Participants are individuals seeking care for their IBD at the University of Washington (UW). 
Inclusion criteria include participants who (1) have a health care provider diagnosis of IBD as 
reported in the electronic medical record, (2) report at least 2 current, active symptoms (Short 
Inflammatory Bowel Disease Questionnaire [SIBDQ] equal or less than 4 [“some of the time”] 
on any 2 items), (3) are 18 to 75 years old, and (4) are able to read and write in English. 
Participant exclusion criteria include (1) pregnant individuals, (2) significant co-occurring 
mental or physical conditions that would impact study participation, (3) surgery or 
hospitalization within the past month, or (4) living outside of Washington State. 
CSM Intervention 
The 8-session CSM includes patient education about self-management of symptoms using CBT, 
relaxation training, and diet counseling. The intervention will be delivered digitally with skill 
videos, readings, and homework, as well as a weekly phone call or Zoom check-in with a nurse 
trained in CBT. For each session, participants will review information and practice skills on the 
session topic. The content for each session is outlined in Table 2. The weekly phone calls are 
designed to provide accountability and support for achieving the session goals and to enable 
individuals to ask questions about the content. The estimated time of completion is 8 weeks; 
however, participants will have 12 weeks to complete the sessions to allow for unexpected 
events. Intervention fidelity will be monitored using fidelity checklists and through the 
evaluation of a random selection of 20% of participants. 
Also of note, the original CSM intervention was administered as a paper workbook with weekly 
hour-long sessions with a trained advanced practice nurse. To improve accessibility and 
feasibility, we have adapted the intervention to be administered as a web-based intervention with 
weekly phone call check-ins with a CBT-trained nurse. This unique approach expands the 
feasibility and reach of the intervention by enabling patients who may live in rural or 
underserved areas to access the intervention content. To be appropriate for the IBD population, 
the session 1 disease content was modified to include the role of inflammation, the importance of 
endoscopic remission, and information on when to contact their health care provider. The 
intervention content was reviewed by patients and health care providers. 

Table 2. Comprehensive self-management for inflammatory bowel disease (CSM-IBD) by 
session. 
Session 
Content 
Introduction and tracking 
symptoms session 
 
“When to contact your provider” 
 
Introduction to IBDa 
 
Introduction to strategies and self-management 
 
Personalized goals and social support 
Abdominal breathing and 
stress session 
 
Role of stress 
 
Abdominal breathing 
Problem-solving and 
travelling session 
 
Alternative thinking or problem-solving 
 
Travelling 
Healthy thought patterns 
session 
 
Healthy thought patterns 
 
Automatic thoughts 
Sleep and physical intimacy 
session 
 
Sleep tracking 
 
Sleep hygiene 
 
Physical intimacy 
Pain management and quick 
relaxation session 
 
Pain management 
 
Passive or active progressive muscle relaxation 
Healthy eating, tracking, and 
trigger foods session 
 
Tips for healthy eating 
 
Eating out 
Comprehensive plan session
 
Developing a comprehensive plan 
aIBD: inflammatory bowel disease. 

Usual Care 
The intervention group will be compared to a usual care group of participants who meet the same 
eligibility criteria. Due to a current lack of standardization in managing IBD within the clinic 
setting, a usual care patient group most accurately reflects current practice. 
Study Outcomes 
Feasibility Outcomes 
Feasibility will be evaluated for study procedures (recruitment, randomization, and data and 
sample collection) and the CSM-IBD intervention. 
1. Recruitment: the number and percentage of participants prescreened, approached, 
screened, and enrolled. 
2. Randomization: we will assess dropout rates between the CSM-IBD and usual care. 
3. Data collection: the quality of data will focus on the data completeness of questionnaires; 
missing data will be reported as a percentage of missing data and the time point at which 
missing data occurred. Bivariate comparisons will be made between individuals with and 
without missing data. Information on sample collection time, transit time, and processing 
time will be obtained. 
4. Sample collection: we will report how many participants collected biological samples on 
the planned date and the length of time from sample collection to arrival at the laboratory. 
5. Intervention feasibility: measured with the Feasibility of Intervention Measure, in which 
participants respond to 4 questions on a 5-point Likert scale from 1=completely disagree 
to 5=completely agree at the end of the intervention [37]. 
Acceptability Outcomes 
A semistructured interview guide will be used to assess the acceptability of study procedures as 
well as the acceptability and satisfaction with the CSM-IBD. For instance, questions will probe 
for clarity of instructions, the burden of study procedures, and satisfaction with intervention 
content and delivery. Transcripts from participant interviews will be coded by 2 individuals using 
open coding methods to evaluate intervention acceptability. The use of CSM-IBD strategies will 
be assessed at 3 months post intervention by asking participants how often they use each 
strategy, with response options as: not at all or rarely, occasionally (at least 1 day a week), often 
(at least 2 days a week), very often (at least 4 days a week), or almost always [38]. Participants 
will complete the Acceptability of Intervention Measure, which includes 4 questions rated on a 
5-point Likert scale from 1=completely disagree to 5=completely agree [37]. Satisfaction will 
also be measured with the 8-item Client Satisfaction Questionnaire [39]. 
Primary Outcomes 

Quality of Life 
The SIBDQ is a 10-item questionnaire that evaluates the quality of life. Participants respond on a 
7-item Likert scale from all the time to none of the time. Total score range: 10 to 70 [40]. 
Symptoms 
Symptoms are measured using a numeric rating scale where participants report the severity of the 
symptom from 0=not present to 10=worst possible. Symptoms include abdominal pain, anxiety, 
bloating, constipation, depression, diarrhea, fatigue or tiredness, passing gas, sleepiness during 
the day, stress, and urgency.  
Secondary Outcomes 
1. Process variables [41,42] 
o Self-Efficacy for Managing Chronic Disease: a 6-item self-report scale. 
Participants report ranging from not at all confident to totally confident [21]. 
o Index of Self-Regulation: a 9-item scale to measure an individual’s level of self-
regulation [43]. 
o Patient Activation Measure: a 13-item scale that assesses patients’ beliefs, 
knowledge, and confidence in managing their health [44,45]. 
2. Biological signatures: stool samples will be collected by participants and stored 
immediately in home freezers (–20 °C) before transport to the UW School of Nursing 
Biobehavioral Laboratory. Samples will be stored at –80 °C until batch processing. 
o Gut microbiome: fecal microbial communities will be characterized using 
metagenomic shotgun sequencing on the Illumina MiniSeq or NextSeq platforms 
(Illumina, Inc) [46,47]. 
o Fecal calprotectin: fecal calprotectin is a biomarker used to measure inflammation 
in the gut and will be assessed using an enzyme-linked immunosorbent assay 
[48]. 
3. Socioecological factors were selected based on the National Institute for Nursing 
Research’s common data elements and include sex, gender, age, race or ethnicity, 
education level, employment, marital or partner status, household size, and neighborhood 
(urban or rural, zip code). Dietary intake can influence the composition of the gut 
microbiome and symptoms [49]. At the time of the stool collection, subjects will 
complete a detailed 3-day food record (Fred Hutchinson Cancer Research Center 
Nutrition Assessment). 
4. The clinical phenotype will be obtained from the electronic medical record: type of 
disease, time since diagnosis, history of bowel surgery, disease distribution (measured by 

the Montreal Classification), medications, and disease activity (Harvey Bradshaw Index 
for Crohn Disease [50] and Simple Colitis Activity Index for Ulcerative Colitis [51]; <5 
indicates remission). 
5. Health care use will be evaluated from the electronic medical record and patient self-
report, including emergency department use, hospitalizations, outpatient visits, laboratory 
tests, imaging, and procedures, as well as providers’ nonclinical time spent managing 
patients. 
Participant Timeline 
All procedures will occur remotely; data collection will occur digitally through REDCap 
(Research Electronic Data Capture; Vanderbilt University), a secure Health Insurance Portability 
and Accountability Act (HIPAA)–compliant database [52,53]. Individuals meeting eligibility 
criteria and interested in the study will be asked to sign a consent form and HIPAA form prior to 
participating in the study. All participants will complete baseline questionnaires (socioecological 
factors and disease information). Participants will collect a stool sample at home using a stool 
sample collection kit (instructions and researcher contact information will be provided); a 3-day 
food record will be collected starting 2 days before the stool sample collection. The stool 
samples will be placed in home freezers and returned to the School of Nursing Biobehavioral 
Laboratory. Participants will be provided with ice packs, a Styrofoam mailing box, and return 
labels. Stool samples will be stored at –80 °C until batch processing. 
Following baseline data collection, participants will be randomly assigned to the 8-session CSM-
IBD or usual care. Immediately post intervention, participants will complete questionnaires, 
collect a stool sample, and report a 3-day food record. Three months post intervention, 
participants will complete questionnaires and participate in a qualitative data collection 
interview. In addition, participants will report whether or not they are continuing the self-
management skills learned in the intervention. Semistructured interviews will be conducted to 
understand the participants’ perspective on procedural burden and suggestions to improve the 
intervention, including satisfaction with the intervention. Interviews will be recorded and 
transcribed. Participants will be compensated for each assessment completed (baseline, 
immediately post intervention, and 3 months post intervention). To increase retention, 
participants in the usual care group will be provided access to the intervention upon study 
completion. Participants can continue the study despite not completing all data collection 
assessments and all intervention sessions. 
Sample Size 
Based on recommendations for preliminary studies [54], we aim for data on 54 participants (36 
intervention and 18 usual care). The sample size is appropriate for assessing feasibility and 
acceptability (aim 1). For aim 2, we will be able to detect fairly large effect sizes of 0.81 with 

80% power. For aim 3, there will be 80% power to detect a correlation of 0.45. As a pilot study, 
the project is not powered to detect differences or correlations unless they are large. 
Recruitment 
Overview 
Participant recruitment will take place at the UW Inflammatory Bowel Disease Clinics. The UW 
sees a large number of patients with IBD and serves as a tertiary care clinic for patients with IBD 
in the Washington, Oregon, Alaska, Montana, and Idaho regions. Recruitment may occur in three 
different settings: (1) in a clinic, (2) virtually (via telephone, email, or mail), and (3) by posting 
on the Institute of Translational Health Sciences website. All individuals will be informed that 
participating or not participating will not influence the care that they receive. 
In a Clinic 
Weekly prescreening will occur to determine if participants with scheduled IBD clinic 
appointments may be eligible for the study. The goal of prescreening is to enable purposeful 
sampling of patients based on demographic (eg, age and race) and disease characteristics (eg, 
disease activity). Individuals who are eligible will receive a flyer containing the study purpose 
and contact information from either their health care provider or study staff (depending on 
feasibility and current COVID-19 restrictions). Individuals will have time to review the study 
information. Participants can call study staff or complete a REDCap survey to express their 
interest and complete screening questions. 
Virtually 
The team may contact potential participants via phone, email, or mail if in-person recruitment 
becomes difficult or not feasible. All contact will follow the UW’s institutional review board 
guidelines for cold contact recruitment. Those expressing interest in the study will call study staff 
for more information and then complete additional screening questions. 
Institute of Translational Health Sciences Website 
Information regarding the study will be posted on the UW Institute of Translational Health 
Sciences website. Interested individuals can complete the contact form to be contacted by study 
staff and can complete screening questions digitally. 
In all instances, the purpose of the study, study design, and length of time to complete the study 
will be discussed. To assess participants’ understanding of study procedures, individuals will be 
asked to briefly describe the study. Interested individuals will complete additional screening 
questions to confirm whether patients meet the specified inclusion and exclusion criteria. 
Screening questionnaires may be completed over the phone or electronically via REDCap, based 
on patient preference. Those meeting inclusion or exclusion criteria will be invited to participate 
in the study, sign a consent form, and begin data collection. Throughout the entire process of 

informed consent, from the first contact with the patient, the potential participants are able to ask 
any questions or delay making a decision. This screening and recruitment process will continue 
until the target sample size has been reached. 
Intervention Allocation 
A computer adaptive randomization procedure using a modification of the minimization method 
proposed by Pocock and Simon [55] will be used to balance groups based on SIBDQ at baseline. 
Once the data are entered into the computer, the computer program will return the participants’ 
group assignment. 
Statistical Analysis 
Feasibility 
The number and percentage will be calculated for participants who were prescreened, 
approached, screened, and enrolled (recruitment). We will assess dropout rates between the 
CSM-IBD and usual care (randomization). Quality of data will focus on the data completeness of 
questionnaires; missing data will be reported, and bivariate comparisons will be made between 
individuals with and those without missing data (data collection). We will report how many 
participants collected biological samples within the desired timeframe (sample collection). The 
mean and SD will be reported for the Feasibility of Intervention Measure (intervention 
feasibility). 
Acceptability 
Transcripts from participant interviews will be coded by 2 individuals using open coding 
methods (acceptability and satisfaction). In addition, numbers and percentages will be reported 
for participants who continue to use self-management strategies 3 months post intervention. 
Primary Outcomes 
Data from the 2 follow-up time points (immediate and 3 months post intervention) will be 
analyzed together using linear mixed models for each of the outcomes. For example, one model 
will have a change in the quality of life from baseline to immediate and 3 months post 
intervention as the outcomes, subject as a random effect, time (immediate or 3 months) as a 
within-subject fixed factor, and treatment group as an across-subject fixed factor. Baseline 
quality of life will be included as a covariate in the model, as will any baseline variables that 
differ between the 2 treatment groups. The parameter for the treatment group factor will provide 
an estimate of the treatment effect, that is, the difference between the treatment groups in mean 
change in the quality of life, and a 95% CI on the estimated difference will be computed. We 
hypothesize participants in the CSM-IBD will report a greater reduction in symptoms compared 
to those in usual care. A second model will also include an interaction between group and time to 
test whether the treatment effect is different at the 2 post intervention times. Additional analyses 
will estimate treatment effects separately for men and women. 

Secondary Outcomes 
Analyses of microbiome data will use 3 summary measures—Shannon diversity, richness, 
and Firmicutes/Bacteroidetes ratio—as well as the relative abundance of bacterial families (eg, 
family Ruminococcaceae) and genera and will control for the read count. For diet, we will focus 
on protein and fiber intake, as our previous work has indicated these may be important dietary 
intake components related to the gut microbiome. First, we will examine the associations 
between socioecological, clinical phenotype, and biological signatures with symptoms at 
baseline in the total sample using Pearson correlation or Spearman rank correlation based on 
measure distributions. Scatter plots will be used to visually display these associations. Second, 
we will examine associations between socioecological, clinical phenotypes, and biological 
signatures at baseline and response to intervention in the intervention group. Response to 
intervention is conceptualized as an increase of 8 points on the SIBDQ scale (quality of life) [40] 
or a 50% decrease from baseline in the GI symptom score [27]. Among the intervention group, 
we will use the t test and chi-square test to compare socioecological factors, clinical phenotypes, 
and biological signatures among patients with and without a response to treatment. 
Monitoring 
This study has been classified as a minimal-risk study. The principal investigator has the 
responsibility for study oversight, including patient safety and data quality, as well as submitting 
reports to the funder and the institutional review board. Due to the low-risk nature of the CSM-
IBD, we do not anticipate any adverse events or serious adverse events. The data safety and 
monitoring team will meet quarterly to review the study. The team will monitor accrual, 
withdrawals, data quality, timeliness of data submission, protocol compliance, and the types and 
frequency of adverse events and serious adverse events. No interim analysis or stopping rules are 
currently planned. However, if any adverse events or serious adverse events are reported, the 
data safety and monitoring team will meet within a week to discuss the event and any potential 
changes needed to the study procedures. 
Ethics and Dissemination 
Data Management 
Study data will be collected and stored on REDCap. Participants will be assigned a unique study 
identification number. Only study members will have access to the data through a password-
protected system and will have access to the least amount of data required for their position using 
limitations in REDCap user rights. The study will use ongoing quality control procedures during 
data collection, storage, and processing, including the use of the REDCap data quality module. 
Ethics Approval 
The institutional review board at the UW approved this protocol (STUDY 00015210) and 
determined the study to be minimal risk. This study is registered in ClinicalTrials.gov 

(NCT05651542). Any amendments to the study will be reviewed by the institutional review 
board and subsequently updated in the ClinicalTrials.gov registry. Participants in the usual care 
group will be offered access to the CSM-IBD intervention after they complete the 6-month data 
collection. 
Dissemination 
Study findings will be disseminated through presentations and publications to clinicians and 
researchers. Findings will be reported to the community through lay presentations and social 
media. Individuals will be eligible for authorship based on the International Committee of 
Medical Journal Editors’ recommendations. The study will provide the basis for future research 
on self-management interventions. The findings of the study will be used to refine the 
intervention and develop a full-scale trial with additional recruitment sites throughout diverse 
geographical regions. 
Patient Involvement 
This study is informed by a patient advisory group that was convened for the purpose of 
providing advice and oversight for the study. 
 
Results 
This pilot randomized controlled trial was funded by the National Institute of Nursing Research 
(K23NR020044) in April 2022. Recruitment began on February 20, 2023. As of April 2023, we 
have enrolled 4 participants. We expect the study to be completed by March 2025. 
 
Discussion 
Expected Findings 
This project is focused on evaluating the feasibility, acceptability, and preliminary efficacy of a 
CSM intervention for improving the quality of life and symptoms among individuals with IBD. 
We expect that overall participants will find the intervention acceptable and feasible, as mixed 
methods systematic review reported that greater than 75% of participants in IBD-related 
telehealth and mobile health interventions reported satisfaction with the intervention [56]. We 
also anticipate receiving feedback from participants on ways to improve the intervention. 
Further, we expect to find preliminary signals of efficacy. A similar CSM intervention 
implemented in individuals with IBS showed reductions in anxiety, depression, abdominal pain, 
fatigue, and extraintestinal pain and improvements in sleep and quality of life [25-29]. A recently 
published study of a digital health program in IBD reported promising improvements in stress 
and energy levels, with a participant retention rate of 40% [57]. We hope that our approach of 
incorporating weekly check-ins will lead to higher retention rates. Findings from the study will 

be used to refine the intervention and develop a full-scale trial that will incorporate additional 
recruitment sites from diverse geographical regions. In future trials, we plan to collaborate with a 
variety of clinical practice settings, including community-based and academic settings. 
Strengths and Limitations 
Individuals participating in a pilot self-management intervention may be more interested in or 
engaged in research and self-management than a general clinic population. Additionally, 
recruitment is currently focused on an academic medical setting, which may have a more 
medically refractory group of patients. Thus, expanding recruitment to other sites (eg, 
community sites) may assist with generalizability. To enhance its feasibility and reach, the 
intervention has been adapted into a web-based format. 
Future Directions 
If CSM-IBD proves effective, further research into predictors of response to CSM would be 
warranted, including assessing the correlation with the microbiome, histology, or co-occurring 
illness (eg, depression and anxiety). Other future directions include consideration for 
implementation barriers and facilitators. Future work may consider multilevel interventions that 
can impact the health care system level to promote self-management and quality of life. 
Conclusions 
The results of this study will inform the development of a full-scale clinical trial to examine the 
impact of CSM-IBD compared to usual care. If the intervention demonstrates acceptability and 
efficacy, it could be deployed in a variety of practice settings to improve patient self-
management of IBD. 
Acknowledgments 
KK is supported, in part, by the National Institutes of Nursing Research (K23NR020044). LY 
and SW are supported, in part, by the National Institutes of Nursing Research (T32NR016913). 
We thank Dr John Inadomi for support throughout the process. 
Data Availability 
The data sets generated during this study will be deposited in a publicly available repository at 
study completion. 
 

References 
1. Conley S, Proctor DD, Jeon S, Sandler RS, Redeker NS. Symptom clusters in adults with 
inflammatory bowel disease. Res Nurs Health. 2017;40(5):424-434. [FREE Full text] 
[CrossRef] [Medline] 
2. Farrell D, McCarthy G, Savage E. Self-reported symptom burden in individuals with 
inflammatory bowel disease. J Crohns Colitis. 2016;10(3):315-322. [FREE Full text] 
[CrossRef] [Medline] 
3. Lönnfors S, Vermeire S, Greco M, Hommes D, Bell C, Avedano L. IBD and health-
related quality of life—discovering the true impact. J Crohns Colitis. 2014;8(10):1281-
1286. [CrossRef] [Medline] 
4. Keefer L, Bedell A, Norton C, Hart AL. How should pain, fatigue, and emotional 
wellness be incorporated into treatment goals for optimal management of inflammatory 
bowel disease? Gastroenterology. 2022;162(5):1439-1451. [CrossRef] [Medline] 
5. Turner D, Ricciuto A, Lewis A, D'Amico F, Dhaliwal J, Griffiths AM, et al. International 
Organization for the Study of IBD. STRIDE-II: an update on the selecting therapeutic 
targets in inflammatory bowel disease (STRIDE) initiative of the international 
organization for the study of IBD (IOIBD): determining therapeutic goals for treat-to-
target strategies in IBD. Gastroenterology. 2021;160(5):1570-1583. [CrossRef] [Medline] 
6. Dahlhamer JM, Zammitti EP, Ward BW, Wheaton AG, Croft JB. Prevalence of 
inflammatory bowel disease among adults aged ≥18 years - United States, 2015. MMWR 
Morb Mortal Wkly Rep. 2016;65(42):1166-1169. [FREE Full text] [CrossRef] [Medline] 
7. Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, et al. Worldwide 
incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic 
review of population-based studies. Lancet. 2018;390(10114):2769-2778. [CrossRef] 
[Medline] 
8. Loftus EV. Clinical epidemiology of inflammatory bowel disease: incidence, prevalence, 
and environmental influences. Gastroenterology. 2004;126(6):1504-1517. [Medline] 
9. Hanauer SB. Inflammatory bowel disease: epidemiology, pathogenesis, and therapeutic 
opportunities. Inflamm Bowel Dis. 2006;12(Suppl 1):S3-S9. [CrossRef] [Medline] 
10. Feuerstein JD, Isaacs KL, Schneider Y, Siddique SM, Falck-Ytter Y, Singh S, et al. AGA 
Institute Clinical Guidelines Committee. AGA clinical practice guidelines on the 
management of moderate to severe ulcerative colitis. Gastroenterology. 
2020;158(5):1450-1461. [FREE Full text] [CrossRef] [Medline] 
11. Feuerstein JD, Ho EY, Shmidt E, Singh H, Falck-Ytter Y, Sultan S, et al. AGA Clinical 
practice guidelines on the medical management of moderate to severe luminal and 

perianal fistulizing Crohn's disease. Gastroenterology. 2021;160(7):2496-2508. [FREE 
Full text] [CrossRef] [Medline] 
12. Lewis JD, Rutgeerts P, Feagan BG, D'haens G, Danese S, Colombel J, et al. Correlation 
of stool frequency and abdominal pain measures with simple endoscopic score for 
Crohn's disease. Inflamm Bowel Dis. 2020;26(2):304-313. [CrossRef] [Medline] 
13. Farrell D, Artom M, Czuber-Dochan W, Jelsness-Jørgensen LP, Norton C, Savage E. 
Interventions for fatigue in inflammatory bowel disease. Cochrane Database Syst Rev. 
2020;4(4):CD012005. [FREE Full text] [CrossRef] [Medline] 
14. Duff W, Haskey N, Potter G, Alcorn J, Hunter P, Fowler S. Non-pharmacological 
therapies for inflammatory bowel disease: recommendations for self-care and physician 
guidance. World J Gastroenterol. 2018;24(28):3055-3070. [FREE Full text] [CrossRef] 
[Medline] 
15. Regueiro M, Click B, Anderson A, Shrank W, Kogan J, McAnallen S, et al. Reduced 
unplanned care and disease activity and increased quality of life after patient enrollment 
in an inflammatory bowel disease medical home. Clin Gastroenterol Hepatol. 
2018;16(11):1777-1785. [FREE Full text] [CrossRef] [Medline] 
16. Xu F, Carlson SA, Liu Y, Greenlund KJ. Urban-rural differences in health care utilization 
for inflammatory bowel disease in the USA, 2017. Dig Dis Sci. 2022;67(8):3601-3611. 
[CrossRef] [Medline] 
17. Rohatinsky N, Boyd I, Dickson A, Fowler S, Peña-Sánchez J, Quintin C, et al. 
Perspectives of health care use and access to care for individuals living with 
inflammatory bowel disease in rural Canada. Rural Remote Health. 2021;21(2):6358. 
[FREE Full text] [CrossRef] [Medline] 
18. Lorig KR, Holman H. Self-management education: history, definition, outcomes, and 
mechanisms. Ann Behav Med. 2003;26(1):1-7. [Medline] 
19. Miller WR, Lasiter S, Bartlett Ellis R, Buelow JM. Chronic disease self-management: a 
hybrid concept analysis. Nurs Outlook. 2015;63(2):154-161. [FREE Full text] [CrossRef] 
[Medline] 
20. Lorig KR, Sobel DS, Stewart AL, Brown BW, Bandura A, Ritter P, et al. Evidence 
suggesting that a chronic disease self-management program can improve health status 
while reducing hospitalization: a randomized trial. Med Care. 1999;37(1):5-14. [Medline] 
21. Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management 
program on patients with chronic disease. Eff Clin Pract. 2001;4(6):256-262. [FREE Full 
text] [Medline] 

22. Conley S, Redeker N. A systematic review of self-management interventions for 
inflammatory bowel disease. J Nurs Scholarsh. 2016;48(2):118-127. [FREE Full text] 
[CrossRef] [Medline] 
23. Kennedy AP, Nelson E, Reeves D, Richardson G, Roberts C, Robinson A, et al. A 
randomised controlled trial to assess the effectiveness and cost of a patient orientated self 
management approach to chronic inflammatory bowel disease. Gut. 2004;53(11):1639-
1645. [FREE Full text] [CrossRef] [Medline] 
24. Elkjaer M, Shuhaibar M, Burisch J, Bailey Y, Scherfig H, Laugesen B, et al. E-health 
empowers patients with ulcerative colitis: a randomised controlled trial of the web-guided 
'Constant-care' approach. Gut. 2010;59(12):1652-1661. [CrossRef] [Medline] 
25. Heitkemper MM, Jarrett ME, Levy RL, Cain KC, Burr RL, Feld A, et al. Self-
management for women with irritable bowel syndrome. Clin Gastroenterol Hepatol. 
2004;2(7):585-596. [Medline] 
26. Jarrett ME, Cain KC, Barney PG, Burr RL, Naliboff BD, Shulman R, et al. Balance of 
autonomic nervous system predicts who benefits from a self-management intervention 
program for irritable bowel syndrome. J Neurogastroenterol Motil. 2016;22(1):102-111. 
[FREE Full text] [CrossRef] [Medline] 
27. Jarrett ME, Cain KC, Burr RL, Hertig VL, Rosen SN, Heitkemper MM. Comprehensive 
self-management for irritable bowel syndrome: randomized trial of in-person vs. 
combined in-person and telephone sessions. Am J Gastroenterol. 2009;104(12):3004-
3014. [FREE Full text] [CrossRef] [Medline] 
28. Kamp KJ, Weaver KR, Sherwin LB, Barney P, Hwang S, Yang P, et al. Effects of a 
comprehensive self-management intervention on extraintestinal symptoms among 
patients with IBS. J Psychosom Res. 2019;126:109821. [FREE Full text] [CrossRef] 
[Medline] 
29. Deechakawan W, Heitkemper MM, Cain KC, Burr RL, Jarrett ME. Anxiety, depression, 
and catecholamine levels after self-management intervention in irritable bowel syndrome. 
Gastroenterol Nurs. 2014;37(1):24-32. [CrossRef] [Medline] 
30. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. 
CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel 
group randomised trials. BMJ. 2010;340:c869. [FREE Full text] [Medline] 
31. Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 
explanation and elaboration: guidance for protocols of clinical trials. BMJ. 
2013;346:e7586. [FREE Full text] [Medline] 

32. Ryan P, Sawin KJ. The individual and family self-management theory: background and 
perspectives on context, process, and outcomes. Nurs Outlook. 2009;57(4):217-225. 
[FREE Full text] [CrossRef] [Medline] 
33. Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 
1977;84(2):191-215. [Medline] 
34. Keefer L, Kiebles JL, Taft TH. The role of self-efficacy in inflammatory bowel disease 
management: preliminary validation of a disease-specific measure. Inflamm Bowel Dis. 
2011;17(2):614-620. [FREE Full text] [CrossRef] [Medline] 
35. Hofmann SG, Asnaani A, Vonk IJJ, Sawyer AT, Fang A. The efficacy of cognitive 
behavioral therapy: a review of meta-analyses. Cognit Ther Res. 2012;36(5):427-440. 
[FREE Full text] [CrossRef] [Medline] 
36. Gracie DJ, Irvine AJ, Sood R, Mikocka-Walus A, Hamlin PJ, Ford AC. Effect of 
psychological therapy on disease activity, psychological comorbidity, and quality of life 
in inflammatory bowel disease: a systematic review and meta-analysis. Lancet 
Gastroenterol Hepatol. 2017;2(3):189-199. [FREE Full text] [CrossRef] [Medline] 
37. Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, et al. Psychometric 
assessment of three newly developed implementation outcome measures. Implement Sci. 
2017;12(1):108. [FREE Full text] [CrossRef] [Medline] 
38. Zia JK, Barney P, Cain KC, Jarrett ME, Heitkemper MM. A comprehensive self-
management irritable bowel syndrome program produces sustainable changes in behavior 
after 1 year. Clin Gastroenterol Hepatol. 2016;14(2):212-219.e1-2. [FREE Full text] 
[CrossRef] [Medline] 
39. Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties 
and correlations with service utilization and psychotherapy outcome. Eval Program 
Plann. 1982;5(3):233-237. [Medline] 
40. Irvine EJ, Zhou Q, Thompson AK. The Short Inflammatory Bowel Disease 
Questionnaire: a quality of life instrument for community physicians managing 
inflammatory bowel disease. CCRPT investigators. Canadian Crohn's relapse prevention 
trial. Am J Gastroenterol. 1996;91(8):1571-1578. [Medline] 
41. Moore SM, Schiffman R, Waldrop-Valverde D, Redeker NS, McCloskey DJ, Kim MT, et 
al. Recommendations of common data elements to advance the science of self-
management of chronic conditions. J Nurs Scholarsh. 2016;48(5):437-447. [FREE Full 
text] [CrossRef] [Medline] 

42. Redeker NS, Anderson R, Bakken S, Corwin E, Docherty S, Dorsey SG, et al. Advancing 
symptom science through use of common data elements. J Nurs Scholarsh. 
2015;47(5):379-388. [FREE Full text] [CrossRef] [Medline] 
43. Yeom HA, Choi M, Belyea M, Fleury J. Psychometric evaluation of the index of self-
regulation. West J Nurs Res. 2011;33(2):268-285. [CrossRef] [Medline] 
44. Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the patient activation 
measure (PAM): conceptualizing and measuring activation in patients and consumers. 
Health Serv Res. 2004;39(4 Pt 1):1005-1026. [FREE Full text] [CrossRef] [Medline] 
45. Hibbard JH. Assessing Measurement Properties of the PAM 10 and 13. 2017. 
URL: https://s3-us-west-2.amazonaws.com/insignia/Comparing-PAM-10-to-PAM-
13.pdf [accessed 2023-05-09] 
46. Li N, Koester ST, Lachance DM, Dutta M, Cui JY, Dey N. Microbiome-encoded bile acid 
metabolism modulates colonic transit times. iScience. 2021;24(6):102508. [FREE Full 
text] [CrossRef] [Medline] 
47. Luna RA, Oezguen N, Balderas M, Venkatachalam A, Runge JK, Versalovic J, et al. 
Distinct microbiome-neuroimmune signatures correlate with functional abdominal pain in 
children with autism spectrum disorder. Cell Mol Gastroenterol Hepatol. 2017;3(2):218-
230. [FREE Full text] [CrossRef] [Medline] 
48. Biotech H. Human Calprotectin: Elisa Kit Product Information and Manual. Pittsburgh. 
Thermo Fisher Scientific Inc; 2019. 
49. Singh RK, Chang H, Yan D, Lee KM, Ucmak D, Wong K, et al. Influence of diet on the 
gut microbiome and implications for human health. J Transl Med. 2017;15(1):73. [FREE 
Full text] [CrossRef] [Medline] 
50. Elliott PR, Lennard-Jones JE, Hathway N. Simple index of Crohn's disease activity. 
Lancet. 1980;1(8173):876. [CrossRef] [Medline] 
51. Walmsley RS, Ayres RC, Pounder RE, Allan RN. A Simple Clinical Colitis Activity 
Index. Gut. 1998;43(1):29-32. [FREE Full text] [Medline] 
52. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data 
capture (REDCap)—a metadata-driven methodology and workflow process for providing 
translational research informatics support. J Biomed Inform. Apr 2009;42(2):377-381. 
[FREE Full text] [CrossRef] [Medline] 
53. Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, et al. REDCap 
Consortium. The REDCap consortium: building an international community of software 
platform partners. J Biomed Inform. Jul 2019;95:103208. [FREE Full text] [CrossRef] 
[Medline] 

54. Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs 
Health. 2008;31(2):180-191. [CrossRef] [Medline] 
55. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic 
factors in the controlled clinical trial. Biometrics. 1975;31(1):103-115. [Medline] 
56. Davis SP, Ross MSH, Adatorwovor R, Wei H. Telehealth and mobile health interventions 
in adults with inflammatory bowel disease: a mixed-methods systematic review. Res Nurs 
Health. 2021;44(1):155-172. [CrossRef] [Medline] 
57. Oddsson SJ, Gunnarsdottir T, Johannsdottir LG, Amundadottir ML, Frimannsdottir A, 
Molander P, et al. A new digital health program for patients with inflammatory bowel 
disease: preliminary program evaluation. JMIR Form Res. 2023;7:e39331. [FREE Full 
text] [CrossRef] [Medline] 
 
 
 
Abbreviations 
CBT: cognitive behavioral therapy 
CSM: comprehensive self-management intervention 
CSM-IBD: comprehensive self-management for inflammatory bowel 
disease 
HIPAA: Health Insurance Portability and Accountability Act 
IBD: inflammatory bowel disease 
IFSMT: Individual and Family Self-Management Theory 
SIBDQ: Short Inflammatory Bowel Disease Questionnaire 
UW: University of Washington