Diet and Stress Management Combined with Advanced Therapy for Crohns Disease and Ulcerative Colitis A Pragmatic Randomized Clinical Trial

What this Trial Is About

Inflammatory Bowel Disease IBD, which includes Crohns Disease CD and Ulcerative Colitis UC, is a chronic immune-related condition with recurring flare-ups. This trial is designed to explore whether adding lifestyle changes like mindfulness, stress management, and nutrition support to advanced medical treatments improves clinical remission and disease activity scores in patients with active CD and UC. The study is a pragmatic, randomized trial conducted at a single site. Participants will be divided into four groups to compare different combinations of lifestyle modifications alongside advanced therapies. Group A receives visits with both a dietician and a GI psychologist soon after starting advanced therapy, followed by a second joint visit about a month later. Group B meets with a dietician early and later may see a psychologist after three months. Group C starts with psychologist visits and may later see a dietician. Group D is offered both services only after three months. All visits can be in person or virtual. Throughout the study, participants will complete questionnaires and may provide blood and stool samples at specific visits. Researchers will monitor changes in clinical remission at 12 and 24 weeks as the primary outcome, along with clinical responses and patient perceptions about their illness. The study includes careful tracking of disease activity and participant adherence, supporting comprehensive evaluation over the course of treatment.

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