NCT05651542

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 15, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

March 14, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

December 5, 2022

Last Update Submit

January 7, 2026

Conditions

Inflammatory Bowel DiseasesUlcerative ColitisCrohn Disease

Keywords

IBDUCCD

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Change in Quality of Life

    Baseline, 3 months, 6 months

  • Change in Symptoms

    Baseline, 3 months, 6 months

Other Outcomes (5)

  • Self-Efficacy for Managing Chronic Disease

    Baseline, 3 months, 6 months

  • Index of Self-Regulation

    Baseline, 3 months, 6 months

  • Patient Activation Measure

    Baseline, 3 months, 6 months

  • +2 more other outcomes

Study Arms (2)

Comprehensive Self-Management

EXPERIMENTAL

The 8 week intervention is delivered online with a brief weekly check-in with a registered nurse.

Behavioral: Comprehensive Self-Management Intervention

Usual care group

OTHER

The control group will receive standard care without the comprehensive self-management intervention.

Other: Control

Interventions

Comprehensive Self-Management InterventionBEHAVIORAL

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.

Comprehensive Self-Management
ControlOTHER

The control group will receive standard care.

Usual care group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (2)

  • 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.

    PMID: 40243391DERIVED

  • Kamp 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.

    PMID: 37285195DERIVED

MeSH Terms

Conditions

Inflammatory Bowel DiseasesColitis, UlcerativeCrohn Disease

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Kendra Kamp, PHD, RN

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Biobehavioral Nursing & Health Informatics

Study Record Dates

First Submitted

December 5, 2022

First Posted

December 15, 2022

Study Start

March 14, 2023

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

January 9, 2026

Record last verified: 2026-01

Locations

US(1)