Inflammatory Bowel DiseasesNCT05651542
A Comprehensive Self-Management Intervention for Individuals With Inflammatory Bowel Disease
A study testing Comprehensive Self-Management Intervention in people with Inflammatory Bowel Diseases and Ulcerative Colitis, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- What is being tested?
- Comprehensive Self-Management Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2023to 30 Sep 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthcare provider diagnosis of inflammatory bowel disease
- Report current symptoms
- Able to read and write in English
Who cannot join
- Live outside of Washington state
- Bowel-related surgery within the past month
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Comprehensive Self-Management Intervention, Control
- Keywords
- IBD, UC, CD
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Self-Management InterventionBehavioural
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.
ControlOther
The control group will receive standard care.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Self-Management | Experimental | The 8 week intervention is delivered online with a brief weekly check-in with a registered nurse. Receives: Behavioral: Comprehensive Self-Management Intervention |
| Usual care group | Other | The control group will receive standard care without the comprehensive self-management intervention. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility
Percentage comprised of number of participants enrolled divided by the number of participants approached.
Measured: From screening to enrollment, an average of one month
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). Range: 1 to 5. A higher score indicates greater feasibility.
Measured: 3 months
Secondary outcomes (2)
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. A higher score indicates greater quality of life.
Measured: Baseline, 3 months, 6 months
Change in Abdominal Pain Symptoms
Abdominal pain was measured using a numeric rating scale where participants report the severity of the symptom from not present (0) to worst possible (10).
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start14 Mar 2023
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Kendra Kamp, University of Washington
- Investigators
- Kendra Kamp, PHD, RN, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651542
- Sponsor's protocol ID
- STUDY00015210
- Other IDs
- 1K23NR020044-01A1
- Status last verified
- Sep 2026
- First submitted
- 5 Dec 2022
- Last updated
- 28 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PubMed 40243391Kamp K, Clark-Snustad K, Yoo L, Winders S, Cain K, Levy RL, 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 Jun 7;12:e46307. doi: 10.2196/46307.
PubMed 37285195