A Comprehensive Self-Management Intervention for Individuals With Inflammatory Bowel Disease

Study Overview
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Brief Summary
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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.

Official Title
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A Comprehensive Self-Management Intervention for Individuals With Inflammatory Bowel Disease

Conditions
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Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease

Intervention / Treatment
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* Behavioral: Comprehensive Self-Management Intervention
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthcare provider diagnosis of inflammatory bowel disease Report current symptoms Able to read and write in English Exclusion Criteria: Live outside of Washington state Bowel-related surgery within the past month

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comprehensive Self-Management<br>The 8 week intervention is delivered online with a brief weekly check-in with a registered nurse. | Behavioral: Comprehensive Self-Management Intervention<br>* In addition to standard care, participants receive content on self-management which includes cognitive behavioral therapy, relaxation, and diet. Weekly phone calls provide support for achieving the sessions goals.<br>|
| Other: Usual care group<br>The control group will receive standard care without the comprehensive self-management intervention. | Other: Control<br>* The control group will receive standard care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment feasibility | Percentage comprised of number of participants enrolled divided by the number of participants approached. | From screening to enrollment | 
| Intervention feasibility | Measured with the Feasibility of Intervention Measure (FIM) in which participants respond to four questions on a 5-point Likert scale from completely disagree (1) to completely agree (5). | 3 months | 
| Acceptability | A semi-structured interview guide will be used to assess acceptability of study procedures as well as acceptability and satisfaction with the intervention. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life | Short Inflammatory Bowel Disease Questionnaire is a 10-item questionnaire which evaluates 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. | Baseline, 3 months, 6 months | 
| Change in Symptoms | Symptoms are measured using a numeric rating scale where participants report the severity of the symptom from not present (0) to worst possible (10). Symptoms include: abdominal pain, anxiety, bloating, constipation, depressed, diarrhea, fatigue/tiredness, passing gas, sleepiness during the day, stress, and urgency. | Baseline, 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBD, UC, CD