Inflammatory Bowel DiseasesNCT05206734
Risk of Mental Health Conditions in Children and Young Adults With Inflammatory Bowel Disease and Influence on Health
An observational study of Inflammatory Bowel Diseases and Depressive Episode, run by Momentum Data at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 5 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Depressive Episode, Recurrent Depressive Disorder
- What is being tested?
- No specific intervention
- How many people
- 19,469 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jan 2022to 15 Aug 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Cases of IBD in childhood and young adults and age, gender and GP matched controls.
Who may be able to join
- Aged between 5 years and 25 years
- Registration with a general practices (GP) contributing routinely collected electronic healthcare data to the Optimum Patient Care Research Database (OPCRD) for more than 6 months during the follow up period
- A recorded diagnosis of IBD in the clinical record (cases)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Psychological Comorbidities in Paediatric and Young Adults With Inflammatory Bowel Disease, and the Impacts on Quality-of-life, Disease Severity and Resource Utilisation: A Population-based Cohort Study in the United Kingdom
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.
Read the detailed description
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.
- Conditions
- Inflammatory Bowel Diseases, Depressive Episode, Recurrent Depressive Disorder, Anxiety Disorder, Psychological Disorder, Self Harm
- Being tested
- No specific intervention
- Medical subject headings
- Inflammatory Bowel Diseases, Depressive Disorder, Anxiety Disorders, Mental Disorders, Self-Injurious Behavior, Suicide, Attempted, Feeding and Eating Disorders, Body Dysmorphic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No specific interventionOther
Observational analysis of usual care only.
| Study group | Role | What they receive |
|---|---|---|
| IBD Cases | 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). Receives: Other: No specific intervention | |
| Matched Controls | 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. Receives: Other: No specific intervention | |
| IBD cases with mental health condition | 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 Receives: Other: No specific intervention | |
| IBD cases without mental health condition | 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 Receives: Other: No specific intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 years of follow-up.
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: 5 years of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start5 Jan 2022
- Primary completion31 Mar 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 19,469 participants (actual)
Sponsor and investigators
- Lead sponsor
- Momentum Data
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Optimum Patient Care
- Responsible party
- Sponsor
- Investigators
- Andrew McGovern, MD, Principal investigator, Momentum Data
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206734
- Sponsor's protocol ID
- P043
- Status last verified
- May 2025
- First submitted
- 10 Jan 2022
- Last updated
- 15 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Cooney R, Barrett K, Russell RK. Impact of mental health comorbidity in children and young adults with inflammatory bowel disease: a UK population-based cohort study. BMJ Open. 2024 Feb 28;14(2):e080408. doi: 10.1136/bmjopen-2023-080408.
PubMed 38418244Cooney R, Tang D, Barrett K, Russell RK. Children and Young Adults With Inflammatory Bowel Disease Have an Increased Incidence and Risk of Developing Mental Health Conditions: A UK Population-Based Cohort Study. Inflamm Bowel Dis. 2024 Aug 1;30(8):1264-1273. doi: 10.1093/ibd/izad169.
PubMed 37603846
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Psychological Comorbidities in Paediatric and Young Adults With Inflammatory Bowel Disease, and the Impacts on Quality-of-life, Disease Severity and Resource Utilisation: A Population-based Cohort Study in the United Kingdom
- ClinicalTrials.gov ID
- NCT05206734
- Acronym / sponsor ID
- P043
- Conditions
- Inflammatory Bowel Diseases, Depressive Episode, Recurrent Depressive Disorder, Anxiety Disorder, Psychological Disorder, Self Harm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19,469 participants (actual)
- Lead sponsor
- Momentum DataIndustry (pharma, biotech, devices)
- Collaborators
- Optimum Patient Care
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 25 Jan 2022 (actual)
- Results
- Posted 15 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IBD Cases | – | Other: No specific interventionAll 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). |
| Matched Controls | – | Other: No specific interventionPeople 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. |
| IBD cases with mental health condition | – | Other: No specific interventionA 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 |
| IBD cases without mental health condition | – | Other: No specific interventionA 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 |
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Cases of IBD in childhood and young adults and age, gender and GP matched controls.
Key inclusion criteria (3 listed)
- Aged between 5 years and 25 years
- Registration with a general practices (GP) contributing routinely collected electronic healthcare data to the Optimum Patient Care Research Database (OPCRD) for more than 6 months during the follow up period
- A recorded diagnosis of IBD in the clinical record (cases)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| No specific interventionObservational analysis of usual care only. | Other | IBD Cases, IBD cases with mental health condition, IBD cases without mental health condition, Matched Controls |
Primary outcome
Stream 1: Percentage of Participants Who Developed Any Mental Health Condition
Time frame: 5 years
Cumulative incidence (percentage of participants in each arm who developed any mental health condition) was calculated using Kaplan-Meier analysis
Stream 1: Relative Risk of Any Mental Health Condition
Time frame: Retrospective data assessed from 2010-2020, up to 10 years
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.
Stream 2: Relative Risk of Bowel Symptoms (Quality of Life Indicator)
Time frame: 5 years of follow-up.
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.
Stream 2: Relative Risk of Sleep Disturbance (Quality of Life Indicator)
Time frame: 5 years of follow-up.
Relative risk in participants with mental health conditions compared with those without MH conditions. Calculated using Cox regression.
Stream 2: Relative Risk of Low Mood (Emotional Function)
Time frame: 5 years of follow-up.
Relative risk in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression.
3 secondary outcomes
Stream 1: Lifetime Risk of Developing a Mental Health Condition
Time frame: Retrospective data assessed from 2010-2020, up to 10 years
Stream 2: Relative Risk of Increased Primary Care Utilisation
Time frame: 5 years of follow-up.
Stream 2: Relative Risk of Increased Hospital Admissions
Time frame: 5 years of follow-up.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38418244Cooney R, Barrett K, Russell RK. Impact of mental health comorbidity in children and young adults with inflammatory bowel disease: a UK population-based cohort study. BMJ Open. 2024 Feb 28;14(2):e080408. doi: 10.1136/bmjopen-2023-080408.
- Derived from this study: PubMed 37603846Cooney R, Tang D, Barrett K, Russell RK. Children and Young Adults With Inflammatory Bowel Disease Have an Increased Incidence and Risk of Developing Mental Health Conditions: A UK Population-Based Cohort Study. Inflamm Bowel Dis. 2024 Aug 1;30(8):1264-1273. doi: 10.1093/ibd/izad169.
- Individual participant dataSharing planned: 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.
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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. This study is not recruiting at the moment.
Andrew McGovern, MD principal investigator
Momentum Data
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Depressive Episode, run by Momentum Data at 1 site in United Kingdom.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 15 Jun 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 Kingdom. 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?
Yes. Results are posted in the registry (first posted 15 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stream 1: Percentage of Participants Who Developed Any Mental Health Condition (time frame: 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05206734, which also lists 2 linked publications.
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 15 Jun 2025.