Crohn Disease, Inflammatory Bowel Diseases, Ulcerative Colitis
Conditions
Keywords
IBD, UC, CD
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.
Interventions
BEHAVIORALComprehensive Self-Management Intervention
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.
OTHERControl
The control group will receive standard care.
Sponsors
National Institute of Nursing Research (NINR)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Recruitment feasibility | From screening to enrollment | Percentage comprised of number of participants enrolled divided by the number of participants approached. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fecal Calprotectin | Baseline, 3 months | Level of fecal calprotectin assessed using ELISA. |
| Gut Microbiome | Baseline, 3 months | Fecal microbial communities characterized using 16S rRNA gene sequencing on the Illumina MiniSeq platform (Illumina, Inc. Albany, New York) |
| Patient Activation Measure | Baseline, 3 months, 6 months | a 13-item scale which assess patient's beliefs, knowledge and confidence in managing their health |
| Index of Self-Regulation | Baseline, 3 months, 6 months | a 9-item scale to measure individual's level of self-regulation |
| Self-Efficacy for Managing Chronic Disease | Baseline, 3 months, 6 months | a 6-item self-report scale. Participants report ranging from not at all confident to totally confident. |
Countries
United States
Outcome results
None listed