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Completed

NCT Number: NCT05651542

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

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.

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Ulcerative Colitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Control

Other

The control group will receive standard care.

Primary outcomes

  1. Recruitment feasibility

    Time frame: From screening to enrollment

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

  2. Intervention feasibility

    Time frame: 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).

  3. Acceptability

    Time frame: 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 outcomes

  1. Change in Quality of Life

    Time frame: 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.

  2. Change in Symptoms

    Time frame: 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 outcomes

  1. Self-Efficacy for Managing Chronic Disease

    Time frame: Baseline, 3 months, 6 months

    a 6-item self-report scale. Participants report ranging from not at all confident to totally confident.

  2. Index of Self-Regulation

    Time frame: Baseline, 3 months, 6 months

    a 9-item scale to measure individual's level of self-regulation

  3. Patient Activation Measure

    Time frame: Baseline, 3 months, 6 months

    a 13-item scale which assess patient's beliefs, knowledge and confidence in managing their health

  4. Fecal Calprotectin

    Time frame: Baseline, 3 months

    Level of fecal calprotectin assessed using ELISA.

  5. Gut Microbiome

    Time frame: Baseline, 3 months

    Fecal microbial communities characterized using 16S rRNA gene sequencing on the Illumina MiniSeq platform (Illumina, Inc. Albany, New York)

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 15, 2022
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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