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

University of Washington55 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Inflammatory Bowel Diseases Ulcerative Colitis Crohn Disease

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Recruitment feasibility

Percentage comprised of number of participants enrolled divided by the number of participants approached.

Time frame: 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).

Time frame: 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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 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.