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

University of Washington (Other)
Overall Status
Not yet recruiting
CT.gov ID
National Institute of Nursing Research (NINR) (NIH)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Comprehensive Self-Management Intervention
  • Other: Control

Study Design

Study Type:
Anticipated Enrollment :
54 participants
Intervention Model:
Parallel Assignment
Single (Outcomes Assessor)
Primary Purpose:
Official Title:
A Comprehensive Self-Management Intervention for Individuals With Inflammatory Bowel Disease
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Comprehensive Self-Management

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

Behavioral: 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.

Other: Usual care group

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

Other: Control
The control group will receive standard care.

Outcome Measures

Primary Outcome Measures

  1. Recruitment feasibility [From screening to enrollment]

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

  2. Intervention feasibility [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 [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 Outcome Measures

  1. Change in Quality of Life [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 [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 Outcome Measures

  1. Self-Efficacy for Managing Chronic Disease [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 [Baseline, 3 months, 6 months]

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

  3. Patient Activation Measure [Baseline, 3 months, 6 months]

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

  4. Fecal Calprotectin [Baseline, 3 months]

    Level of fecal calprotectin assessed using ELISA.

  5. Gut Microbiome [Baseline, 3 months]

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

Eligibility Criteria


Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


No locations specified.

Sponsors and Collaborators

  • University of Washington
  • National Institute of Nursing Research (NINR)


  • Principal Investigator: Kendra Kamp, PHD, RN, University of Washington

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Kendra Kamp, Assistant Professor, Biobehavioral Nursing & Health Informatics, University of Washington
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • STUDY00015210
  • 1K23NR020044-01A1
First Posted:
Dec 15, 2022
Last Update Posted:
Dec 15, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Kendra Kamp, Assistant Professor, Biobehavioral Nursing & Health Informatics, University of Washington
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 15, 2022