RecruitingNot ApplicableNCT07168499

Diet and Stress Management Combined With Advanced Therapy for Crohn's and Ulcerative Colitis

D-SCAPE - Diet and Stress Management Combined With Advanced Therapy for Crohn's and Ulcerative Colitis - A Pragmatic Clinical Trial

Sponsor

Massachusetts General Hospital

Enrollment

160 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

IBD (Inflammatory Bowel Disease)

Summary

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: 1. Group A - Subjects will receive a visit with an IBD dietician and a visit with an IBD GI psychologist within the first month of advanced therapy initiation and another visit with both parties 4+/-2 weeks after the first intervention visit. 2. Group B - Subjects will receive a visit with an IBD dietician within the first month of advanced therapy initiation and another visit 4+/-2 weeks after the first intervention visit. They will later be offered a visit with an IBD GI psychologist after 3 months (after assessment of our primary outcomes). 3. Group C - Subjects will receive a visit with an IBD psychologist within the first month of advanced therapy initiation and another visit with the IBD GI psychologist 4+/-2 weeks after the first intervention visit. They will later be offered a visit with an IBD dietician after 2 months (after assessment of our primary outcomes). 4. Group D - Subjects will be offered a visit with an IBD GI psychologist and IBD dietician after 3 months (after assessment of our primary outcomes). 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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether making dietary changes and stress management practices alongside standard advanced drug therapy (biologics or JAK inhibitors) leads to better outcomes for people with Crohn's disease or ulcerative colitis (together called inflammatory bowel disease, IBD). The goal is to see if lifestyle changes can enhance the effect of powerful new medications. **You may be eligible if...** - You are 18 years or older - You have a confirmed diagnosis of Crohn's disease, ulcerative colitis, or unspecified IBD - There is recent evidence of active inflammation (from colonoscopy, imaging, or blood tests) - You are about to start a new advanced therapy (such as adalimumab, vedolizumab, ustekinumab, ozanimod, or a JAK inhibitor) **You may NOT be eligible if...** - Your IBD is currently in remission with no active inflammation - You are not starting a new advanced therapy - You are pregnant - You have serious complications like active infections, abscesses, or a bowel obstruction requiring surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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