N/A
N=19,469
Risk of Mental Health Conditions in Children and Young Adults With Inflammatory Bowel Disease and Influence on Health
Inflammatory Bowel Diseases · Depressive Episode · Recurrent Depressive Disorder · Anxiety Disorder · Psychological Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05206734 ↗Enrolled (actual)
19,469
Serious AEs
—
Results posted
Jun 2025
Primary outcome: Primary: Stream 1: Percentage of Participants Who Developed Any Mental Health Condition — 12.0; 9.4 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No specific intervention (Other)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- Momentum Data
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stream 1: Percentage of Participants Who Developed Any Mental Health Condition |
12.0; 9.4 | — |
| PRIMARY Stream 1: Relative Risk of Any Mental Health Condition |
299; 811 | — |
| PRIMARY Stream 2: Relative Risk of Bowel Symptoms (Quality of Life Indicator) |
148; 473 | — |
| PRIMARY Stream 2: Relative Risk of Sleep Disturbance (Quality of Life Indicator) |
26; 83 | — |
| PRIMARY Stream 2: Relative Risk of Low Mood (Emotional Function) |
63; 119 | — |
| SECONDARY Stream 1: Lifetime Risk of Developing a Mental Health Condition |
31.1; 25.1 | — |
| SECONDARY Stream 2: Relative Risk of Increased Primary Care Utilisation |
12881; 58153 | — |
| SECONDARY Stream 2: Relative Risk of Increased Hospital Admissions |
339; 1295 | — |
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 those diagnosed with IBD.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT05206734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.