Diet and Stress Management Combined With Advanced Therapy for Crohn's and Ulcerative Colitis
Not applicable · Testing Diet Management and Stress Management · 1 site · Massachusetts General Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Diet Management (a behavioral program) and Stress Management (a behavioral program) as supportive care (to help with symptoms or quality of life). Condition(s) listed: IBD (Inflammatory Bowel Disease).
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 4 more requirement(s). There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 160 participants are expected to take part.
- Start date: 2025-09-15.
- Main results expected around 2027-05-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Change marked by clinical remission of IBD (12 weeks, 24 weeks)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | IBD (Inflammatory Bowel Disease) |
| Lead sponsor | Massachusetts General Hospital |
| Enrollment | 160 (estimated) |
| Start date | 2025-09-15 |
| Primary completion (est.) | 2027-05-01 |
| First posted | 2025-09-11 |
| Last updated | 2025-11-06 |
| Official title | D-SCAPE - Diet and Stress Management Combined With Advanced Therapy for Crohn's and Ulcerative Colitis - A Pragmatic Clinical Trial |
| ClinicalTrials.gov ID | NCT07168499 |
Interventions
- Diet Management (Behavioral)
Visit with IBD dietician for diet management specifically for IBD - Stress Management (Behavioral)
Visit with IBD GI psychologist for stress management
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol. 2. At least 18 years of age 3. Established diagnosis of CD, UC, or IBD-unspecified 4. Recent (within 6 months) objective evidence of active IBD on colonoscopy or intestinal ultrasound or cross-sectional imaging or elevated inflammatory markers (CRP) 5. 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 6. 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. 7. 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. Exclusion Criteria: 1. Inability to provide informed consent or unwilling or unlikely to comply with the requirements of the study. 2. Initiation of advanced therapy for extra-intestinal symptoms alone 3. Known eating disorders 4. Already receiving dietary therapy or stress management interventions 5. Severe untreated psychiatric comorbidity including history of suicidal thoughts 6. Evidence of untreated infection (e.g. Clostridium difficile) 7. Presence of stoma or J-pouch 8. Female subjects who are pregnant, lactating, or intending to become pregnant during the study period 9. On total parental nutrition (TPN) or already following a therapeutic diet for IBD.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital | Boston, Massachusetts | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.