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Crohn's DiseaseDMBINCT06510296

Digital Mind Body Intervention Among Black and Hispanic Patients Living With Inflammatory Bowel Disease

A study testing Digital Mind Body Intervention mobile application in people with Crohn's Disease and Ulcerative Colitis, run by Montefiore Medical Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The bidirectional effects between psychological distress and inflammatory bowel disease (IBD) activity mean that not only does increased IBD activity trigger psychological distress, but psychological distress triggers increased IBD activity (i.e., gut-brain interaction). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Digital Mind Body Intervention mobile application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
Jul 2027to Sep 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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • age ≥ 18 years
  • self-identify as Black/African American and/or Hispanic/Latino(a/x)
  • diagnosed with Crohn's disease or ulcerative colitis
  • ability to provide informed consent in English
  • elevated psychological distress: at least one T-score within 2.5 standard deviations above the mean -- NIH Toolbox Perceived Stress Scale or in the domains of either Anxiety or Depression on the NIH PROMIS-29.

Who cannot join

  • Anxiety, depression, or perceived stress T-scores above 2.5 standard deviations above the mean.
  • Current suicidality, past suicide attempt, or psychiatric hospitalization.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Montefiore Medical Center

    The Bronx, New York, 10467

    Ruby Greywoode, 347-671-8216

    Shalika Fnu, 347-968-4203

Other trials in United States

About this study

The bidirectional effects between psychological distress and inflammatory bowel disease (IBD) activity mean that not only does increased IBD activity trigger psychological distress, but psychological distress triggers increased IBD activity (i.e., gut-brain interaction). Comorbid psychological distress is linked to increased health resource utilization and poor health-related quality of life (HRQoL). This has prompted calls for integrating psychological care into IBD practice with restoration of quality of life as a clinical target of IBD management alongside endoscopic healing. The IBD Social Cognitive Model (IBD SCM) posits that patient psycho-behavioral modifiers contribute to IBD outcomes and not disease modifiers alone. While a co-localized gastro-psychologist in an IBD medical home is an emerging mode of delivering psycho-behavioral care among people living with IBD, access and scalability of this form of support is not yet widespread, particularly in resource-limited settings. Though many people with IBD have significant psychological distress, mental health care is underutilized with cost cited as a barrier.

The emergence of digital interventions in clinical practice presents an opportunity to address access, scalability, and cost barriers. However, current testing of digital interventions to address gut-brain interactions (digital mind-body intervention, DMBI) among people with IBD involves mostly women with high educational attainment who have full time employment and do not receive social service benefits. Individuals with limited resources and those from racial and ethnic minority groups (e.g. Black, Hispanic) often have socioecological factors, such as healthcare access and mental health stigma, that impede their use of psycho-behavioral resources. DMBI development informed by participatory research approaches are, therefore, critical to facilitate equitable engagement and utilization. Beneficial effects of psycho-behavioral treatment among people with IBD are strongest for those who have psychological distress and for acceptance, mindfulness, and values-based approaches.

Although high quality evidence demonstrates psychological improvement with DMBI in IBD, feasibility and acceptability of applying DMBI to IBD patients from racial and ethnic minority groups is lacking.

Read the detailed description

Prior to conducting the randomized pilot study, as part of Aim 1, virtual patient focus groups will be conducted, based on the IBD social-cognitive model (IBD SCM), with a prototype DMBI to assess resonance and preferences on how to convey and display intervention concepts and components. Semi-structured interviews will be conducted among gastroenterology professionals (GIs) to assess perceived needs and barriers to DMBI acceptance and use in clinical care of Black and Hispanic patients with IBD, and define intervention elements.

Aim 2 will be guided by the needs/barriers identified in Aim 1, a functional DMBI app will be developed. A formative/summative evaluation of the app intervention will be conducted through iterative patient user testing to ensure functionality and usability (e.g. accessibility/ease of use, relevant and non-stigmatizing content).

Aim 3, the basis for this registration, will consist of an 8-week pilot of the refined DMBI intervention, developed in Aim 2 among a separate group of patients, to assess the feasibility and acceptability of DMBI among Black and Hispanic patients with IBD. It is anticipated that Aim 3 will not initiate until July, 2027. Earlier Aims, not represented in this record, are in progress.

Being tested
Digital Mind Body Intervention mobile application
Medical subject headings
Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital Mind Body Intervention mobile applicationBehavioural

    A DMBI mobile application with psychoeducation and skill-building in illness perception, coping, mindfulness, and disease acceptance informed by needs/barriers of Black and Hispanic patients with IBD who have elevated psychological distress and GI professionals caring for IBD patients.

Study groups in NCT06510296
Study groupRoleWhat they receive
Digital Mind Body InterventionExperimentalParticipants randomized to the Digital Mind Body mobile intervention will receive a unique user identification (user ID) to access the DMBI mobile application. Randomized in a 2:1 ratio for DMBI intervention vs Waitlist Control
Receives: Behavioral: Digital Mind Body Intervention mobile application
Waitlist ControlNo interventionPatients randomized to the Waitlist Control arm/group will not receive the DMBI until the end of the study. During the study, to control for expectancy and attention, the Waitlist Control will receive a weekly email with generic tips on a healthy lifestyle in IBD. Randomized in a 2:1 ratio for DMBI intervention vs Waitlist Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility - DMBI recruitment rate

    DMBI recruitment rate will be determined by the proportion of eligible patients who enroll into the trial. A benchmark to define this feasibility outcome will be ≥ 30% of eligible patients enrolling.

    Measured: 8 weeks

  2. Feasibility - DMBI retention rate

    DMBI Retention rate will be determined by the proportion of enrolled patients who complete all DMBI modules. A benchmark to define this feasibility outcome will be ≥ 70% of enrolled patients completing all DMBI modules.

    Measured: 8 weeks

  3. Feasibility - DMBI adherence

    DMBI adherence will be assessed by the percentage of completed activities per module will be determined. A benchmark to define this feasibility outcome will be ≥ 50% of completed activities per module.

    Measured: 8 weeks

Secondary outcomes (9)
  1. Illness Perception

    The 8-item Brief Illness Perception Questionnaire (BIPQ) will be used to assess self-reported Illness Perception. Responses to the eight questions related are scored from 0 (negligible illness impact) to 10 (intense illness impact) for a possible scoring range of 0-80. Higher scores indicate more severe patient perception of illness impact. Group mean scores will be summarized.

    Measured: Week 0 (Baseline) and at 8 weeks

  2. IBD self-efficacy

    IBD self-efficacy will be evaluated based on the 13-item IBD Self Efficacy Scale (IBD-SES) which measure the composite score across four domains of self-efficacy (managing stress and emotions, medical care, symptoms and disease, and maintaining remission). Responses to the 13 questions are scored from 0 (Not sure at all) to 10 (Totally sure) for a possible scoring range of 0-130. Higher scores are associated with increased patient self-efficacy across the four domains. Group mean scores will be summarized.

    Measured: Week 0 (Baseline) and at 8 weeks

  3. Disease acceptance

    Patient disease acceptance will be assessed using the 20-item Digestive Disease Acceptance Questionnaire (DDAQ). The DDAQ consists of 20 statements asking patients to rate the truth of each statement on a scale ranging from 0 (Never True) to 6 (Always True) for an overall possible scoring range of 0-120. Higher scores are associated with increased patient disease acceptance. Group mean scores will be summarized.

    Measured: Week 0 (Baseline) and at 8 weeks

  4. Mindfulness

    Mindfulness is evaluated based on the 15-item Five Facet Mindfulness Questionnaire (FFMQ-15). The FFMQ measures mindfulness with regards to thoughts, experiences, and actions in daily life across five subscales. Responses to the positively worded statements (Statements 1-2, 5-6, 10-12, 15) are scored from 1 (Never or very rarely true) to 5 (Very often or always true). Responses to the negatively worded statements (Statements 3-4, 7-9, 13-14) are scored from 5 (Never or very rarely true) to 1 (Very often or always true) for an overall possible scoring range of 15-75. Higher scores are indicative of someone who is more mindful in their everyday life. Group mean scores will be summarized.

    Measured: Week 0 (Baseline) and at 8 weeks

  5. GI-specific symptom anxiety (GSA)

    GI-specific symptom anxiety will be based on responses to the 15-item Visceral Sensitivity Index (VSI) questionnaire. The VSI consists of 15 statements describing how people respond to abdominal symptoms/discomfort. Individual responses are scored on a scale ranging from 1 (Strongly Disagree) to 6 (Strongly Agree) yielding a range of possible scores from 15 (no GSA) to 90 (severe GSA). Lower scores are associated with higher GSA. Group mean scores will be summarized.

    Measured: Week 0 (Baseline) and at 8 weeks

  6. Resilience

    Resilience will be determined based on the 14-item Resilience Scale for Inflammatory Bowel Disease (RISE IBD) scale. RISE-IBD consists of 14 statements governing four domains scored on a scale ranging from 0-4. Positively worded statements in the survey (Statements 1-2, 4-5, 7, 9-13) are scored from 0 (Not True) to 4 (Always True) and negatively worded statements in the survey (Statements 3, 6, 8 and 14) are reverse scored from 0 (Always True) to 4 (Not True) for a possible overall scoring range of 0-56. Higher scores reflect greater patient resilience. Group mean scores will be summarized.

    Measured: Week 0 (Baseline) and at 8 weeks

  7. Health-related Quality of Life

    The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 questionnaire will be used to assess Health-related Quality of Life. PROMIS-29 consists of 29 questions/statements which include 4 items across 7 domains along with a single Pain Intensity item. Pain Intensity is measured on a scale from 0 (No Pain) to 10 (Worst pain imaginable). Responses to the other 28 items are scored from 1-5. Raw scores are converted to a T-score that centers at mean T-score of 50 with a Standard Deviation of 10 in a general, reference population. Higher scores indicate higher degree of the measured trait. Group mean scores will be summarized.

    Measured: Week 0 (Baseline) and at 8 weeks

  8. IBD Activity for Crohn's Disease (CD) Patients

    For patients with CD, IBD activity will be assessed using the Short Crohn's Disease Activity Index (CDAI). The CDAI consists of 3 questions assessing CD symptoms/activity daily over the prior 7 days. The three questions relate to the number of liquid or soft stools each day; abdominal pain severity each day; and general well-being each day. Scoring is summarized as follows:

    44 + (2 x the number of liquid or soft stools each day for 7 days) + 5 x the sum of seven daily abdominal pain ratings (0 = none, 1 = mild, 2 = moderate, 3 = severe)] + 7 x the sum of seven general well-being ratings (0 = generally well, 1 = slightly under par, 2 = poor, 3 = very poor, 4 = terrible)]

    Overall CDAI scores range from 0 to approximately 600. Higher scores are associated with increased Crohn's disease severity. Group mean scores will be summarized.

    Measured: Week 0 (Baseline) and at 8 weeks

  9. IBD Activity for Ulcerative Colitis (UC) Patients

    For patients with UC, IBD activity will be assessed using Simple Clinical Colitis Activity index (SCCAI). The SCCAI consists of 6 questions assessing UC disease symptoms. Three questions: Bowel Frequency (per day), Urgency of Defecation, and Blood in Stool are scored on a 0-3 scale with higher scores indicating increasing severity). Bowel Frequency (per night) is scored from 0-2 with higher scores denoting greater frequency and General well-being is scored from 0-4 with higher scores indicative of decreasing well being. A final question assigns a point per extracolonic manifestation for any of the following features (uveitis, pyoderma gangrenosum, erythema nodosum, or arthropathy). Overall SCCAI range is 0-19 with higher overall scores being associated with increased severity of UC symptoms. Group mean scores will be summarized.

    Measured: Week 0 (Baseline) and at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2024
  2. Study startJul 2027 (estimated)
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06510296
Sponsor's protocol ID
2024-16064
Other IDs
1K12TR004411, K23DK142064
Acronym
DMBI
Status last verified
Sep 2026
First submitted
15 Jul 2024
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Digital Mind Body Intervention mobile application in people with Crohn's Disease and Ulcerative Colitis, run by Montefiore Medical Center 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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 14 Sep 2026. 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 Ruby Greywoode, MD (347-671-8211, rgreywoode@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility - DMBI recruitment rate (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 14 Sep 2026.

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