An observational study in Inflammatory Bowel Diseases, Depressive Episode and Recurrent Depressive Disorder, sponsored by Momentum Data. Completed at 1 site in United Kingdom. Open to participants aged 5 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-15.
Sponsored by Momentum Data · Observational
This study is a large population-based analysis in the United Kingdom (UK) using routine primary care data to investigate the impacts on quality-of-life outcomes and use of healthcare services in people aged 5 - 25 years diagnosed with Inflammatory Bowel Disease (IBD) and the impacts of mental health conditions in those diagnosed with IBD.
This study will use routinely electronic medical record (EMR) data from primary care practices within the Optimum Patient Care Research Database (OPCRD).
Stream 1 primary objective is to compare the prevalence and cumulative incidence of mental health conditions in children, adolescents and young adults (aged 5-25 years) with a diagnosis of Inflammatory Bowel Disease (IBD), compared to matched population controls without a diagnosis of IBD. The secondary objective is to determine the severity of mental health outcomes in those with and without a diagnosis of IBD.
Stream 2 primary objective is to determine the impact of mental health conditions in children, adolescents and young adults (aged 5-25 years) diagnosed with IBD on quality-of-life indicators, such as records for absence from work or school, unemployment, sleep disturbance and substance abuse.
The secondary objectives are to compare indicators of IBD severity, such as medication use, surgical intervention, nutritional supplement prescriptions and markers of nutritional status including underweight or growth retardation,and healthcare resource utilisation.These impacts and indicators will be assessed using participants that have been diagnosed with IBD, comparing those with the presence of a mental health condition to those without a mental health condition.
1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 426 are open to participants now.
This study's enrollment of 19,469 is above the median of 140 across 626 observational studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →Momentum Data is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Cases of IBD in childhood and young adults and age, gender and GP matched controls.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All incident cases of Inflammatory Bowel Disease (IBD); comprising of Ulcerative Colitis, Crohn's Disease and IBD Unclassified in children, adolescents and young adults up to their 25th birthday. Cases will be defined based on an algorithm using diagnostic codes from the electronic medical record (EMR).
Other: No specific intervention
People without a diagnosis in their electronic medical record (ERM) of Inflammatory Bowel Disease, matched on age group, sex, ethnicity (consistent with UK census categories: White, Asian, Black, Mixed, Other), index of multiple deprivation based on postcode, and by practice where numbers allow.
Other: No specific intervention
A subset of the IBD cases comprising of those participants with the presence of a mental health condition at the same date as their IBD diagnosis. Mental health defined by the diagnosis of any of depression (recurrent depressive disorder or depressive episode), non-phobia-related anxiety disorder (AD), eating disorders, body image disorder, attention-deficit disorder, behavioural disorders, adjustment disorder, acute stress disorder, schizophrenia, bipolar disorder or post-traumatic stress disorder
Other: No specific intervention
A subset of the IBD cases comprising of those participants with the absence of a mental health condition at the same date as their IBD diagnosis. Mental health defined by the diagnosis of any of depression (recurrent depressive disorder or depressive episode), non-phobia-related anxiety disorder (AD), eating disorders, body image disorder, attention-deficit disorder, behavioural disorders, adjustment disorder, acute stress disorder, schizophrenia, bipolar disorder or post-traumatic stress disorder
Other: No specific intervention
Observational analysis of usual care only.
Stream 1: Percentage of Participants Who Developed Any Mental Health Condition
Cumulative incidence (percentage of participants in each arm who developed any mental health condition) was calculated using Kaplan-Meier analysis
Time frame: 5 years
Stream 1: Relative Risk of Any Mental Health Condition
Calculated using Cox proportional hazards models using matched controls as the reference group. Adjusted for age, sex, socioeconomic status, ethnicity, and other common chronic childhood conditions.
Time frame: Retrospective data assessed from 2010-2020, up to 10 years
Stream 2: Relative Risk of Bowel Symptoms (Quality of Life Indicator)
Bowel symptoms consist of abdominal pain, bloating, discomfort and diarrhoea. Relative risk in participants with mental health conditions compared with those without mental health (MH) conditions. Calculated using negative binomial regression.
Time frame: 5 years of follow-up.
Stream 2: Relative Risk of Sleep Disturbance (Quality of Life Indicator)
Relative risk in participants with mental health conditions compared with those without MH conditions. Calculated using Cox regression.
Time frame: 5 years of follow-up.
Stream 2: Relative Risk of Low Mood (Emotional Function)
Relative risk in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression.
Time frame: 5 years of follow-up.
Stream 1: Lifetime Risk of Developing a Mental Health Condition
Probability of developing a mental health condition by age 25 years.Estimated using modified Cox regression models
Time frame: Retrospective data assessed from 2010-2020, up to 10 years
Stream 2: Relative Risk of Increased Primary Care Utilisation
Relative risk of increased primary care visits in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression.
Time frame: 5 years of follow-up.
Stream 2: Relative Risk of Increased Hospital Admissions
Relative risk of increased hospital admissions in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression.
Time frame: 5 years of follow-up.
| Milestone | IBD Cases | Matched Controls |
|---|---|---|
| Started | 3898 | 15571 |
| Ibd cases with mental health condition | 295 | 0 |
| Ibd cases without mental health condition | 1648 | 0 |
| Completed | 3898 | 15571 |
| Not completed | 0 | 0 |
Cumulative incidence (percentage of participants in each arm who developed any mental health condition) was calculated using Kaplan-Meier analysis
| percentage of participants | IBD Cases | Matched Controls |
|---|---|---|
| Stream 1: Percentage of Participants Who Developed Any Mental Health Condition | 12.0 (10.5 to 13.4) | 9.4 (8.7 to 10.1) |
Calculated using Cox proportional hazards models using matched controls as the reference group. Adjusted for age, sex, socioeconomic status, ethnicity, and other common chronic childhood conditions.
| Participants | IBD Cases | Matched Controls (Reference Group) |
|---|---|---|
| Stream 1: Relative Risk of Any Mental Health Condition | 299 | 811 |
Bowel symptoms consist of abdominal pain, bloating, discomfort and diarrhoea. Relative risk in participants with mental health conditions compared with those without mental health (MH) conditions. Calculated using negative binomial regression.
| Participants | IBD Cases With Mental Health Condition | IBD Cases Without Mental Health Condition (Reference Group) |
|---|---|---|
| Stream 2: Relative Risk of Bowel Symptoms (Quality of Life Indicator) | 148 | 473 |
Relative risk in participants with mental health conditions compared with those without MH conditions. Calculated using Cox regression.
| Participants | IBD Cases With Mental Health Condition | IBD Cases Without Mental Health Condition (Reference Group) |
|---|---|---|
| Stream 2: Relative Risk of Sleep Disturbance (Quality of Life Indicator) | 26 | 83 |
Relative risk in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression.
| Participants | IBD Cases With Mental Health Condition | IBD Cases Without Mental Health Condition (Reference Group) |
|---|---|---|
| Stream 2: Relative Risk of Low Mood (Emotional Function) | 63 | 119 |
Probability of developing a mental health condition by age 25 years.Estimated using modified Cox regression models
| percentage of participants analyzed | IBD Cases | Matched Controls |
|---|---|---|
| Stream 1: Lifetime Risk of Developing a Mental Health Condition | 31.1 | 25.1 |
Relative risk of increased primary care visits in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression.
| Count of prinary care interactions | IBD Cases With Mental Health Condition | IBD Cases Without Mental Health Condition (Reference Group) |
|---|---|---|
| Stream 2: Relative Risk of Increased Primary Care Utilisation | 12881 | 58153 |
Relative risk of increased hospital admissions in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression.
| Count of general hospital admissions | IBD Cases With Mental Health Condition | IBD Cases Without Mental Health Condition (Reference Group) |
|---|---|---|
| Stream 2: Relative Risk of Increased Hospital Admissions | 339 | 1295 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| People Diagnosed With Inflammatory Bowel Disease and Presence of a Mental Health Condition | — | — | — |
| People Diagnosed With Inflammatory Bowel Disease and Absence of a Mental Health Condition | — | — | — |
| Age, Continuous(years) | IBD Cases | Matched Controls | Total |
|---|---|---|---|
| Median | 19 (15 to 21) | 19 (15 to 21) | 19 (15 to 21) |
| Age, Customized(Participants) | IBD Cases | Matched Controls | Total |
|---|---|---|---|
| Age subgroup — 5-11 years | 364 | 1466 | 1830 |
| Age subgroup — 12-17 years | 1178 | 4684 | 5862 |
| Age subgroup — 18-25 years | 2356 | 9421 | 11777 |
| Sex: Female, Male(Participants) | IBD Cases | Matched Controls | Total |
|---|---|---|---|
| Female | 1819 | 7262 | 9081 |
| Male | 2079 | 8309 | 10388 |
| Race/Ethnicity, Customized(Participants) | IBD Cases | Matched Controls | Total |
|---|---|---|---|
| Asian or Asian British | 276 | 1000 | 1276 |
| Black or Black British | 35 | 176 | 211 |
| White | 1963 | 7536 | 9499 |
| Mixed | 50 | 136 | 186 |
| Not stated | 183 | 703 | 886 |
| Other | 173 | 548 | 721 |
| Missing | 1218 | 5472 | 6690 |
| Deprivation quintile(Participants) | IBD Cases | Matched Controls | Total |
|---|---|---|---|
| 1 (most deprived) | 243 | 1019 | 1262 |
| 2 | 749 | 2973 | 3722 |
| 3 | 1172 | 4623 | 5795 |
| 4 | 1193 | 4811 | 6004 |
| 5 (least deprived) | 209 | 847 | 1056 |
| Missing | 332 | 1298 | 1630 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — OPCRD data can be access by bone fide researchers for specific research projects subject to approval by Anonymised Data Ethics \& Protocol Transparency (ADEPT) Committee. The data used for this study cannot be made available without such approval.
Supporting information: Study protocol
Time frame: The data will be available subject to approval for two years after the study publication date.
Access criteria: Data sharing is subject to ADEPT Committee approval.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Momentum Data