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

Not Applicable

Recruiting

• Conditions: Crohn Disease; Inflammatory Bowel Diseases; Ulcerative Colitis
• Interventions: Behavioral: Comprehensive Self-Management Intervention; Other: Control

• Registration Number: NCT05651542
• Lead Sponsor: University of Washington

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-12
• Study First Posted: 2022-12-15
• Study Start: 2023-03-14
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Healthcare provider diagnosis of inflammatory bowel disease
• Report current symptoms
• Able to read and write in English

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Exclusion Criteria

• Live outside of Washington state
• Bowel-related surgery within the past month

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comprehensive Self-Management	Comprehensive Self-Management Intervention	The 8 week intervention is delivered online with a brief weekly check-in with a registered nurse.
Usual care group	Control	The control group will receive standard care without the comprehensive self-management intervention.

Primary Outcome Measures

Name	Time	Method
Recruitment feasibility	From screening to enrollment	Percentage comprised of number of participants enrolled divided by the number of participants approached.
Intervention feasibility	3 months	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).
Acceptability	6 months	A semi-structured interview guide will be used to assess acceptability of study procedures as well as acceptability and satisfaction with the intervention.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life	Baseline, 3 months, 6 months	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.
Change in Symptoms	Baseline, 3 months, 6 months	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.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States