IBD (Inflammatory Bowel Disease)D-SCAPENCT07168499
Diet and Stress Management Combined With Advanced Therapy for Crohn's and Ulcerative Colitis
A study testing Diet Management and Stress Management in people with IBD (Inflammatory Bowel Disease), run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBD (Inflammatory Bowel Disease)
- What is being tested?
- Diet Management and Stress Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2025to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aarushi Gupta contact
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Emily A Nolan, DNP, MS, BA, PMHNP-BC, RN, 617-724-7559, enolan4@mgb.org
Aarushi Gupta, agupta57@mgh.harvard.edu
About this study
Official title: D-SCAPE - Diet and Stress Management Combined With Advanced Therapy for Crohn's and Ulcerative Colitis - A Pragmatic Clinical Trial
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.
Read more
Groups:
- 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.
- 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).
- 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).
- 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.
- Conditions
- IBD (Inflammatory Bowel Disease)
- Being tested
- Diet Management, Stress Management
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet ManagementBehavioural
Visit with IBD dietician for diet management specifically for IBD
Stress ManagementBehavioural
Visit with IBD GI psychologist for stress management
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks, 24 weeks
Secondary outcomes (2)
Clinical responses
A secondary objective is to evaluate if clinical response to medications is changed with the interventions as measured by the HBI disease activity index.
Measured: 12 weeks, 24 weeks
Change in patient illness perception about disease and self-reported outcomes
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."
Measured: 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start15 Sep 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD (Inflammatory Bowel Disease)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashwin Ananthakrishnan, Massachusetts General Hospital
- Investigators
- Ashwin Ananthakrishnan, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168499
- Sponsor's protocol ID
- 2025P001274
- Acronym
- D-SCAPE
- Status last verified
- Nov 2025
- First submitted
- 28 Aug 2025
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- D-SCAPE / 2025P001274
- Conditions
- IBD (Inflammatory Bowel Disease)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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).
- 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).
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A - Combined diet + stress management | Active comparator | Behavioral: Diet Management, Behavioral: Stress ManagementSubjects 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. |
| Group B - Diet Alone | Active comparator | Behavioral: Diet ManagementSubjects 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). |
| Group C - Stress management alone | Active comparator | Behavioral: Stress ManagementSubjects 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). |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet ManagementVisit with IBD dietician for diet management specifically for IBD | Behavioural | Group A - Combined diet + stress management, Group B - Diet Alone |
| Stress ManagementVisit with IBD GI psychologist for stress management | Behavioural | Group A - Combined diet + stress management, Group C - Stress management alone |
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.
2 secondary outcomes
Clinical responses
Time frame: 12 weeks, 24 weeks
Change in patient illness perception about disease and self-reported outcomes
Time frame: 12 weeks, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aarushi Gupta contact
Ashwin Ananthakrishnan, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet Management and Stress Management in people with IBD (Inflammatory Bowel Disease), run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily A Nolan, DNP, MS, BA, PMHNP-BC, RN (617-724-7559, enolan4@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change marked by clinical remission of IBD (time frame: 12 weeks, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.