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

NCT07168499 | Recruiting

• 1 other identifier: 2025P001274
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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. 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).

Conditions

IBD (Inflammatory Bowel Disease)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Clinical responses

  12 weeks, 24 weeks

• Change in patient illness perception about disease and self-reported outcomes

  12 weeks, 24 weeks

Other Outcomes (2)

• Evaluate the effect of intervention on change in fecal calprotectin levels between baseline and 12 weeks

  12 weeks

• Change in levels of blood tests

  12 weeks

Study Arms (4)

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.

Behavioral: Diet Management; Behavioral: Stress Management

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).

Behavioral: Diet Management

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).

Behavioral: Stress Management

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).

Interventions

Diet Management BEHAVIORAL

Visit with IBD dietician for diet management specifically for IBD

Group A - Combined diet + stress management; Group B - Diet Alone

Stress Management BEHAVIORAL

Visit with IBD GI psychologist for stress management

Group A - Combined diet + stress management; Group C - Stress management alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol.
• At least 18 years of age
• Established diagnosis of CD, UC, or IBD-unspecified
• Recent (within 6 months) objective evidence of active IBD on colonoscopy or intestinal ultrasound or cross-sectional imaging or elevated inflammatory markers (CRP)
• Initiating advanced therapy (anti-TNF agents, anti-integrin agents, anti-IL12/23, anti-IL23 agents, S1P receptor modulators, JAK inhibitors) for IBD per usual clinical care within 2 weeks of baseline/randomization, regardless of prior exposure to advanced therapies or disease duration
• Other non-biologic IBD medications must remain stable during the treatment period and no medication changes are planned with the exception of tapering of corticosteroids.
• Current disease activity defined as a Harvey Bradshaw index \> 4 at baseline (week 0) for CD subjects or Simple Clinical Colitis Activity Index \> 2 at baseline (week 0) for UC subjects or having had a recent exacerbation being treated with systemic steroids or budesonide.

You may not qualify if:

• Inability to provide informed consent or unwilling or unlikely to comply with the requirements of the study.
• Initiation of advanced therapy for extra-intestinal symptoms alone
• Known eating disorders
• Already receiving dietary therapy or stress management interventions
• Severe untreated psychiatric comorbidity including history of suicidal thoughts
• Evidence of untreated infection (e.g. Clostridium difficile)
• Presence of stoma or J-pouch
• Female subjects who are pregnant, lactating, or intending to become pregnant during the study period
• On total parental nutrition (TPN) or already following a therapeutic diet for IBD.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Ashwin Ananthakrishnan, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily A Nolan, DNP, MS, BA, PMHNP-BC, RN

CONTACT

617-724-7559; enolan4@mgb.org

Aarushi Gupta

CONTACT

agupta57@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Clinical Professor

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 11, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: November 6, 2025

Record last verified: 2025-11

Locations

US (1)