IBD (Inflammatory Bowel Disease)
Diet and Stress Management With Advanced Therapy for Crohn’s Disease and Colitis
This study asks whether dietitian support, stress-management support, or both, provided alongside advanced therapy, affect disease activity and other outcomes in adults with active Crohn’s disease, ulcerative colitis, or inflammatory bowel disease–unspecified.
Registry title: Diet and Stress Management Combined With Advanced Therapy for Crohn's and Ulcerative Colitis
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years and older
- Treatment
- Diet Management or Stress Management
- Design
- Randomized
- Central study contact
- Emily A Nolan, DNP, MS, BA, PMHNP-BC, RN617-724-7559enolan4@mgb.org
- Sponsor
- Massachusetts General Hospital
Research question
Does adding dietitian support, stress-management support, or both to advanced therapy change clinical remission, disease activity, illness perception, or other measured outcomes in people with active inflammatory bowel disease?
Participant snapshot
Who the study is looking for
- The study is looking for adults age 18 or older with Crohn’s disease, ulcerative colitis, or inflammatory bowel disease–unspecified.
- Participants must have objective evidence of active inflammatory bowel disease from within the past six months.
- Participants must be starting an eligible advanced therapy for inflammatory bowel disease within two weeks of baseline and randomization.
- The study is being conducted at Massachusetts General Hospital in Boston, Massachusetts.
Participation overview
What participation may involve
All participants begin advanced therapy through usual clinical care and are randomized to receive early diet support, early stress-management support, both, or usual care with the supports offered later. What participation may involve: - Group A has one dietitian visit and one gastrointestinal psychologist visit within the first month of advanced therapy, followed by another visit with each provider 4 ± 2 weeks later. - Group B has a dietitian visit within the first month and another 4 ± 2 weeks later, followed by an offered gastrointestinal psychologist visit after three months. - Group C has a gastrointestinal psychologist visit within the first month and another 4 ± 2 weeks later, followed by an offered dietitian visit after three months. - Group D receives usual care and is offered dietitian and gastrointestinal psychologist visits after three months. - All participants complete questionnaires and may choose to provide blood and stool samples at certain visits. The number and timing of dietitian and psychologist visits depend on group assignment; the registry does not provide a complete schedule of all study visits.
Study interventions
What participants may receive or do
- Diet Management: Participants assigned to this intervention meet with an inflammatory bowel disease dietitian for diet management tailored to inflammatory bowel disease.
- Stress Management: Participants assigned to this intervention meet with an inflammatory bowel disease gastrointestinal psychologist for stress management.
Study design
How the comparison works
This is a single-site, randomized, factorial supportive-care study with four groups: combined diet and stress management, diet alone, stress management alone, and usual care with delayed access to both supports. Participants are assigned randomly among the study groups; the registry does not report the assignment ratio. The study is open-label, meaning the registry reports no masking. The usual-care group does not receive the behavioral interventions before the primary outcome assessment and is offered dietitian and gastrointestinal psychologist visits after three months.
Reported activities
Procedures and tests
- Disease activity is assessed using the Harvey-Bradshaw Disease Activity Index for Crohn’s disease.
- Participants complete the Brief Illness Perception Questionnaire and Patient-Reported Outcomes Measurement Information System questionnaires for depression and anxiety.
- Optional stool samples may be collected, and fecal calprotectin is assessed at baseline and 12 weeks.
- Optional blood samples may be provided; standard-care blood tests assessed at 12 weeks include a complete blood count with differential, comprehensive metabolic panel, C-reactive protein, erythrocyte sedimentation rate, iron studies, and vitamin B12.
- Blood is also processed for metagenomic assessment of changes after the intervention.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be able to give written informed consent before screening and follow the study requirements.
- Participants must be at least 18 years old.
- Participants must have an established diagnosis of Crohn’s disease, ulcerative colitis, or inflammatory bowel disease–unspecified.
- Within the previous six months, participants must have objective evidence of active disease from colonoscopy, intestinal ultrasound, cross-sectional imaging, or elevated C-reactive protein.
- Participants must be starting one of the listed advanced therapies through usual care within two weeks of baseline and randomization; previous advanced-therapy exposure and disease duration do not exclude participation.
- Other non-biologic inflammatory bowel disease medications must stay stable during treatment, except that corticosteroids may be tapered.
- At baseline, participants must meet the specified disease-activity score threshold for Crohn’s disease or ulcerative colitis, or have a recent flare treated with systemic steroids or budesonide.
Possible reasons someone may not be able to join
- People unable to give informed consent, or unwilling or unlikely to follow study requirements, are excluded.
- People starting advanced therapy only for symptoms outside the intestines are excluded.
- People with a known eating disorder are excluded.
- People already receiving dietary therapy or stress-management interventions are excluded.
- People with severe untreated psychiatric illness, including a history of suicidal thoughts, are excluded.
- People with evidence of an untreated infection, such as Clostridium difficile, are excluded.
- People with a stoma or J-pouch are excluded.
- Female participants who are pregnant, breastfeeding, or planning pregnancy during the study are excluded.
- People receiving total parenteral nutrition or already following a therapeutic diet for inflammatory bowel disease are excluded.
Important unknowns
What the record does not make clear
- The registry gives timing for dietitian and psychologist visits but does not provide a complete schedule for questionnaires, samples, or other study visits.
- The registry reports outcome time points and some intervention timing but does not state each participant’s total study duration.
- Participants begin advanced therapy through usual care and generally keep non-biologic medications stable, but the registry does not describe how all treatment changes will be handled.
- The registry does not describe medication washout requirements.
- The registry does not explain what treatment changes or rescue options are allowed if inflammatory bowel disease worsens.
- Recent objective evidence may come from colonoscopy, ultrasound, imaging, or C-reactive protein, but the registry does not say whether the study requires a new endoscopy.
- The registry does not state which care, tests, samples, or visits are billed to participants or insurance.
- The registry does not report whether participants receive compensation.
- The registry does not report parking, transportation, lodging, or other travel support.
- Dietitian and psychologist visits may be in person or virtual, but the registry does not say whether screening, questionnaires, samples, and other activities can be completed remotely.
- The Boston location is listed as recruiting, but the study’s recruitment status was last verified in November 2025.
Before contacting the site
Questions for the study team
- What is the chance of assignment to each of the four groups?
- What is the complete schedule of visits, questionnaires, blood draws, and stool collections?
- Are blood and stool samples entirely optional, and can declining them affect continued participation?
- Which visits can be virtual, and which activities must occur at Massachusetts General Hospital?
- What happens if my symptoms worsen or my inflammatory bowel disease treatment needs to change?
- Are there participant costs, insurance charges, compensation, or travel reimbursements?
- Is the Boston site currently enrolling participants into all four groups?
Before changing care
Questions for your gastroenterologist
- How might starting the planned advanced therapy affect whether this study fits with my current care plan?
- Would keeping my non-biologic medicines stable, except for a possible corticosteroid taper, be medically appropriate for me?
- Are there approved dietary, psychological, or medication alternatives that I should consider alongside or instead of research participation?
- How should my usual gastroenterology team and the research team coordinate disease monitoring and treatment changes?
- Do my recent disease-activity results show enough stability for research participation, and what risks should I discuss with the study team?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
Study design and administration
- Organization
- Massachusetts General Hospital
- Organization class
- Other
- Organization study ID
- 2025P001274
- Lead sponsor
- Massachusetts General Hospital
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Factorial
- Primary purpose
- Supportive Care
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Active Comparator
Group A - Combined diet + stress management
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.
Interventions: Behavioral: Diet Management, Behavioral: Stress Management
Active Comparator
Group B - Diet Alone
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).
Interventions: Behavioral: Diet Management
Active Comparator
Group C - Stress management alone
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).
Interventions: Behavioral: Stress Management
No Intervention
Group D - Usual Care Arm
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
Behavioral
Diet Management
Visit with IBD dietician for diet management specifically for IBD
Behavioral
Stress Management
Visit with IBD GI psychologist for stress management
Eligibility
18 Years and older
All
Not accepted
Inclusion criteria (7)
- Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol.Registry-derived · unreviewed
- At least 18 years of ageRegistry-derived · unreviewed
- Established diagnosis of CD, UC, or IBD-unspecifiedRegistry-derived · unreviewed
- Recent (within 6 months) objective evidence of active IBD on colonoscopy or intestinal ultrasound or cross-sectional imaging or elevated inflammatory markers (CRP)Registry-derived · unreviewed
- 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 durationRegistry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
Exclusion criteria (9)
- Inability to provide informed consent or unwilling or unlikely to comply with the requirements of the study.Registry-derived · unreviewed
- Initiation of advanced therapy for extra-intestinal symptoms aloneRegistry-derived · unreviewed
- Known eating disordersRegistry-derived · unreviewed
- Already receiving dietary therapy or stress management interventionsRegistry-derived · unreviewed
- Severe untreated psychiatric comorbidity including history of suicidal thoughtsRegistry-derived · unreviewed
- Evidence of untreated infection (e.g. Clostridium difficile)Registry-derived · unreviewed
- Presence of stoma or J-pouchRegistry-derived · unreviewed
- Female subjects who are pregnant, lactating, or intending to become pregnant during the study periodRegistry-derived · unreviewed
- On total parental nutrition (TPN) or already following a therapeutic diet for IBD.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Change marked by clinical remission of IBD
Time frame: 12 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.
Secondary outcome
Clinical responses
Time frame: 12 weeks, 24 weeks
A secondary objective is to evaluate if clinical response to medications is changed with the interventions as measured by the HBI disease activity index.
Secondary outcome
Change in patient illness perception about disease and self-reported outcomes
Time frame: 12 weeks, 24 weeks
Subjects in the intervention arms will show clinically significant improvement in perception of IBD illness and self-reported outcomes after week 12 of the treatment period based upon Brief Illness Perception Questionnaire (B-IPQ) and Patient-Reported Outcomes Measurement Information System for Depression and Anxiety. For the B-IPQ, the lowest score is 0 and the highest is 10, with 10 indicating poorer overall view of illness. For both PROMIS questionnaires, a minimum score of 55 is within normal limits while scores above 70 are labelled as "severe."
Recruiting locations in the United States
Massachusetts General Hospital
RecruitingBoston, Massachusetts, 02114, United States
Emily A Nolan, DNP, MS, BA, PMHNP-BC, RN617-724-7559enolan4@mgb.org
Aarushi Guptaagupta57@mgh.harvard.edu
Ashwin Ananthakrishnan, MD, MPH
Maryam Ibrahim
Central study contacts
Registry dates
- First posted
- Sep 11, 2025
- Primary completion
- May 1, 2027
- Overall completion
- May 1, 2028
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.