Actively Recruiting
Diet and Stress Management Combined With Advanced Therapy for Crohn's and Ulcerative Colitis
Led by Massachusetts General Hospital · Updated on 2025-11-06
160
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Diet and Stress Management Combined With Advanced Therapy for Crohn's and Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent and comply with study requirements
- At least 18 years of age
- Established diagnosis of Crohn's Disease, Ulcerative Colitis, or unspecified inflammatory bowel disease
- Recent (within 6 months) objective evidence of active inflammatory bowel disease by colonoscopy, intestinal ultrasound, cross-sectional imaging, or elevated inflammatory markers (CRP)
- Starting advanced therapy for inflammatory bowel disease within 2 weeks of baseline regardless of prior treatment or disease duration
- Stable use of non-biologic inflammatory bowel disease medications during treatment, except corticosteroid tapering
- Current active disease defined by clinical activity scores or recent exacerbation treated with systemic steroids or budesonide
You will not qualify if you...
- Inability or unwillingness to provide informed consent or comply with study requirements
- Starting advanced therapy for symptoms outside the intestines only
- Known eating disorders
- Currently receiving dietary therapy or stress management treatments
- Severe untreated psychiatric conditions including suicidal thoughts
- Untreated infections such as Clostridium difficile
- Presence of stoma or J-pouch
- Female participants who are pregnant, lactating, or planning pregnancy during the study
- Receiving total parenteral nutrition or already following a therapeutic diet for inflammatory bowel disease
AI-Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
E
Emily A Nolan, DNP, MS, BA, PMHNP-BC, RN
CONTACT
A
Aarushi Gupta
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
4
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