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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23NR020044-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comprehensive Self-Management | Experimental | The 8 week intervention is delivered online with a brief weekly check-in with a registered nurse. |
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| Usual care group | Other | The control group will receive standard care without the comprehensive self-management intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life | 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. | Baseline, 3 months, 6 months |
| Change in Symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Efficacy for Managing Chronic Disease | a 6-item self-report scale. Participants report ranging from not at all confident to totally confident. | Baseline, 3 months, 6 months |
| Index of Self-Regulation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kendra Kamp, PHD, RN | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40243391 | Derived | 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. | |
| 37285195 | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2023 | Jan 5, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| Control | Other | The control group will receive standard care. |
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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. |
| Baseline, 3 months, 6 months |
a 9-item scale to measure individual's level of self-regulation
| Baseline, 3 months, 6 months |
| Patient Activation Measure | a 13-item scale which assess patient's beliefs, knowledge and confidence in managing their health | Baseline, 3 months, 6 months |
| Fecal Calprotectin | Level of fecal calprotectin assessed using ELISA. | Baseline, 3 months |
| Gut Microbiome | Fecal microbial communities characterized using 16S rRNA gene sequencing on the Illumina MiniSeq platform (Illumina, Inc. Albany, New York) | Baseline, 3 months |
| D003092 | Colitis |
| D003108 | Colonic Diseases |