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Inflammatory Bowel Disease (IBD), which includes Crohn's Disease (CD) and Ulcerative Colitis (UC), is a chronic, immune-mediated disease characterized by recurrent episodes of relapse. The goal of this single site, pragmatic, randomized trial is to answer if combining lifestyle modifications (mindfulness/stress management + nutrition support) with advanced therapies for induction and maintenance of clinical remission in CD and UC as evaluated by disease activity scores in patients with active CD and UC.
Researchers will compare 4 study arms (Group 1, Group 2, Group 3, and Group 4) to see if combining lifestyle modifications with advanced therapies for induction and maintenance will show improvement in condition as evaluated by disease activity scores.
Groups:
All subjects will be asked to complete a set of questionnaires and have the option to give blood and stool samples throughout the life of their participation in the study at certain visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - Combined diet + stress management | Active Comparator | Subjects will receive a visit with an IBD dietician and a visit with an IBD GI psychologist (whether in person or virtual) within the first month of advanced therapy initiation and another visit with each of the IBD dietician and the IBD GI psychologist 4+/- 2 weeks after first intervention visit. |
|
| Group B - Diet Alone | Active Comparator | Subjects will receive a visit with an IBD dietician (whether in person or virtual) within the first month of advanced therapy initiation and another visit with the IBD dietician 4+/-2 weeks after first intervention visit. They will be later offered a visit with an IBD GI psychologist after 3 months (after assessment of our primary outcomes). |
|
| Group C - Stress management alone | Active Comparator | Subjects will receive a visit with an IBD GI psychologist (whether in person or virtual) within the first month of advanced therapy initiation and another visit with the IBD GI psychologist 4+/-2 weeks after first intervention visit. They will be later offered a visit with an IBD dietician after 3 months (after assessment of our primary outcomes). |
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| Group D - Usual Care Arm | No Intervention | Subjects will be offered a visit with an IBD GI psychologist and IBD dietician (whether in person or virtual) after 3 months (after assessment of our outcomes). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet Management | Behavioral | Visit with IBD dietician for diet management specifically for IBD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change marked by clinical remission of IBD | Subjects in the intervention arms will show clinically significant improvement in IBD symptoms after week 12 of the treatment period based upon disease activity scores using the Harvey-Bradshaw Disease Activity Index (HBI). For the HBI, a score less than 3 indicates remission while a score of 8-9 reflects severe disease. | 12 weeks, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical responses | A secondary objective is to evaluate if clinical response to medications is changed with the interventions as measured by the HBI disease activity index. | 12 weeks, 24 weeks |
| Change in patient illness perception about disease and self-reported outcomes |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of intervention on change in fecal calprotectin levels between baseline and 12 weeks | Fecal calprotein will be measured using standardized testing to assess levels at baseline and at 12 weeks to see if there is a change in levels. | 12 weeks |
| Change in levels of blood tests |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily A Nolan, DNP, MS, BA, PMHNP-BC, RN | Contact | 617-724-7559 | enolan4@mgb.org | |
| Aarushi Gupta | Contact | agupta57@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ashwin Ananthakrishnan, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| Stress Management | Behavioral | Visit with IBD GI psychologist for stress management |
|
Subjects in the intervention arms will show clinically significant improvement in perception of IBD illness and self-reported outcomes after week 12 of the treatment period based upon Brief Illness Perception Questionnaire (B-IPQ) and Patient-Reported Outcomes Measurement Information System for Depression and Anxiety. For the B-IPQ, the lowest score is 0 and the highest is 10, with 10 indicating poorer overall view of illness. For both PROMIS questionnaires, a minimum score of 55 is within normal limits while scores above 70 are labelled as "severe." |
| 12 weeks, 24 weeks |
Blood tests will be taken as part of standard of care and assessed for CBC with differential, comprehensive metabolic panel, C-reactive protein, ESR, serum iron studies, vitamin B12 level and processed for metagenomics to assess for changes post-intervention. |
| 12 weeks |