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

NCT05651542 | Completed Results DMC

• 2 other identifiers: STUDY000152101K23NR020044-01A1
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease

Keywords

IBD; UC; CD

Outcome Measures

Primary Outcomes (2)

• Recruitment Feasibility

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

  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.

  3 months

Secondary Outcomes (2)

• Change in Quality of Life

  Baseline, 3 months, 6 months

• Change in Abdominal Pain Symptoms

  Baseline, 3 months, 6 months

Other Outcomes (4)

• 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

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 Intervention BEHAVIORAL

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

Control OTHER

The control group will receive standard care.

Usual care group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): collaborator
• University of Washington: lead

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: 40243391 DERIVED

• 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: 37285195 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Limitations and Caveats

This study is a pilot study aimed at evaluating feasibility and acceptability

Results Point of Contact

• Title: Kendra Kamp, Assistant Professor
• Organization: University of Washington

giwell@uw.edu

206-221-4617

Study Officials

• Kendra Kamp, PHD, RN

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: September 28, 2026
• Results First Posted: September 28, 2026

Record last verified: 2026-09

Locations

US (1)