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

NCT ID: NCT05651542

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-14

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammatory Bowel Diseases Ulcerative Colitis Crohn Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Comprehensive Self-Management

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

Group Type EXPERIMENTAL

Comprehensive Self-Management Intervention

Intervention Type 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.

Usual care group

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

Group Type OTHER

Control

Intervention Type OTHER

The control group will receive standard care.

Interventions

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Comprehensive 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.

Intervention Type BEHAVIORAL

Control

The control group will receive standard care.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Kendra Kamp

Assistant Professor, Biobehavioral Nursing & Health Informatics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kendra Kamp, PHD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40243391 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37285195 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1K23NR020044-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00015210

Identifier Type: -

Identifier Source: org_study_id

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