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

This study is looking at whether combining lifestyle changes (diet management and stress management) with advanced therapies can help people with Inflammatory Bowel Disease (IBD), which includes Crohn's Disease (CD) and Ulcerative Colitis (UC). You might be able to join if you are at least 18 years old, have a diagnosis of CD, UC, or IBD-unspecified, and have recent signs of active IBD. Researchers will compare four different groups to see if these combined approaches lead to clinical remission, which means your symptoms improve significantly. The study aims to enroll 160 participants and will measure success at 12 and 24 weeks.

Study design
This is an interventional, randomized trial comparing four different groups. It plans to enroll 160 participants.
What's involved
You would visit with an IBD dietician for diet management and an IBD GI psychologist for stress management.
Compensation
Not stated in the trial record.
Follow-up
Your condition will be evaluated at 12 weeks and 24 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07168499

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

Recruiting
NAAges 18+InterventionalSupportive care
Massachusetts General Hospital
~160 participants
Updated 2025-11-06 on ClinicalTrials.gov
What's tested:Diet ManagementStress Management

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change marked by clinical remission of IBD
Measured over 12 weeks, 24 weeks
IBD (Inflammatory Bowel Disease)
1 sites across 1 states
Massachusetts1
  • Ashwin Ananthakrishnan, MD, MPH · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
Emily A Nolan, DNP, MS, BA, PMHNP-BC, RN
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  • Change marked by clinical remission of IBD12 weeks, 24 weeks

    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.