Trial Outcomes & Findings for Risk of Mental Health Conditions in Children and Young Adults With Inflammatory Bowel Disease and Influence on Health (NCT NCT05206734)
NCT ID: NCT05206734
Last Updated: 2025-06-15
Results Overview
Cumulative incidence (percentage of participants in each arm who developed any mental health condition) was calculated using Kaplan-Meier analysis
Recruitment status
COMPLETED
Target enrollment
19469 participants
Primary outcome timeframe
5 years
Results posted on
2025-06-15
Participant Flow
Participant milestones
| Measure |
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).
No specific intervention: Observational analysis of usual care only.
|
Matched Controls
People without a diagnosis in their electronic medical record (ERM) of Inflammatory Bowel Disease, matched on age group, sex, ethnicity (consistent with United Kingdom (UK) census categories: White, Asian, Black, Mixed, Other), index of multiple deprivation based on postcode, and by practice where numbers allow.
No specific intervention: Observational analysis of usual care only.
|
|---|---|---|
|
Overall Study
STARTED
|
3898
|
15571
|
|
Overall Study
IBD Cases With Mental Health Condition
|
295
|
0
|
|
Overall Study
IBD Cases Without Mental Health Condition
|
1648
|
0
|
|
Overall Study
COMPLETED
|
3898
|
15571
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Risk of Mental Health Conditions in Children and Young Adults With Inflammatory Bowel Disease and Influence on Health
Baseline characteristics by cohort
| Measure |
IBD Cases
n=3898 Participants
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).
No specific intervention: Observational analysis of usual care only.
|
Matched Controls
n=15571 Participants
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.
No specific intervention: Observational analysis of usual care only.
|
Total
n=19469 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19 years
n=5 Participants
|
19 years
n=7 Participants
|
19 years
n=5 Participants
|
|
Age, Customized
Age subgroup · 5-11 years
|
364 Participants
n=5 Participants
|
1466 Participants
n=7 Participants
|
1830 Participants
n=5 Participants
|
|
Age, Customized
Age subgroup · 12-17 years
|
1178 Participants
n=5 Participants
|
4684 Participants
n=7 Participants
|
5862 Participants
n=5 Participants
|
|
Age, Customized
Age subgroup · 18-25 years
|
2356 Participants
n=5 Participants
|
9421 Participants
n=7 Participants
|
11777 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1819 Participants
n=5 Participants
|
7262 Participants
n=7 Participants
|
9081 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2079 Participants
n=5 Participants
|
8309 Participants
n=7 Participants
|
10388 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Asian British
|
276 Participants
n=5 Participants
|
1000 Participants
n=7 Participants
|
1276 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or Black British
|
35 Participants
n=5 Participants
|
176 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1963 Participants
n=5 Participants
|
7536 Participants
n=7 Participants
|
9499 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
50 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not stated
|
183 Participants
n=5 Participants
|
703 Participants
n=7 Participants
|
886 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
173 Participants
n=5 Participants
|
548 Participants
n=7 Participants
|
721 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1218 Participants
n=5 Participants
|
5472 Participants
n=7 Participants
|
6690 Participants
n=5 Participants
|
|
Deprivation quintile
1 (most deprived)
|
243 Participants
n=5 Participants
|
1019 Participants
n=7 Participants
|
1262 Participants
n=5 Participants
|
|
Deprivation quintile
2
|
749 Participants
n=5 Participants
|
2973 Participants
n=7 Participants
|
3722 Participants
n=5 Participants
|
|
Deprivation quintile
3
|
1172 Participants
n=5 Participants
|
4623 Participants
n=7 Participants
|
5795 Participants
n=5 Participants
|
|
Deprivation quintile
4
|
1193 Participants
n=5 Participants
|
4811 Participants
n=7 Participants
|
6004 Participants
n=5 Participants
|
|
Deprivation quintile
5 (least deprived)
|
209 Participants
n=5 Participants
|
847 Participants
n=7 Participants
|
1056 Participants
n=5 Participants
|
|
Deprivation quintile
Missing
|
332 Participants
n=5 Participants
|
1298 Participants
n=7 Participants
|
1630 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Participants with a pre-existing diagnosis of mental health were excluded
Cumulative incidence (percentage of participants in each arm who developed any mental health condition) was calculated using Kaplan-Meier analysis
Outcome measures
| Measure |
IBD Cases
n=3423 Participants
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).
No specific intervention: Observational analysis of usual care only.
|
Matched Controls
n=12256 Participants
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.
No specific intervention: Observational analysis of usual care only.
|
|---|---|---|
|
Stream 1: Percentage of Participants Who Developed Any Mental Health Condition
|
12.0 percentage of participants
Interval 10.5 to 13.4
|
9.4 percentage of participants
Interval 8.7 to 10.1
|
PRIMARY outcome
Timeframe: Retrospective data assessed from 2010-2020, up to 10 yearsPopulation: Participants with a pre-existing diagnosis of mental health were excluded
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.
Outcome measures
| Measure |
IBD Cases
n=3423 Participants
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).
No specific intervention: Observational analysis of usual care only.
|
Matched Controls
n=12256 Participants
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.
No specific intervention: Observational analysis of usual care only.
|
|---|---|---|
|
Stream 1: Relative Risk of Any Mental Health Condition
|
299 Participants
|
811 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
IBD Cases
n=295 Participants
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).
No specific intervention: Observational analysis of usual care only.
|
Matched Controls
n=1648 Participants
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.
No specific intervention: Observational analysis of usual care only.
|
|---|---|---|
|
Stream 2: Relative Risk of Bowel Symptoms (Quality of Life Indicator)
|
148 Participants
|
473 Participants
|
PRIMARY outcome
Timeframe: 5 years of follow-up.Relative risk in participants with mental health conditions compared with those without MH conditions. Calculated using Cox regression.
Outcome measures
| Measure |
IBD Cases
n=295 Participants
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).
No specific intervention: Observational analysis of usual care only.
|
Matched Controls
n=1648 Participants
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.
No specific intervention: Observational analysis of usual care only.
|
|---|---|---|
|
Stream 2: Relative Risk of Sleep Disturbance (Quality of Life Indicator)
|
26 Participants
|
83 Participants
|
PRIMARY outcome
Timeframe: 5 years of follow-up.Relative risk in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression.
Outcome measures
| Measure |
IBD Cases
n=295 Participants
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).
No specific intervention: Observational analysis of usual care only.
|
Matched Controls
n=1648 Participants
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.
No specific intervention: Observational analysis of usual care only.
|
|---|---|---|
|
Stream 2: Relative Risk of Low Mood (Emotional Function)
|
63 Participants
|
119 Participants
|
SECONDARY outcome
Timeframe: Retrospective data assessed from 2010-2020, up to 10 yearsProbability of developing a mental health condition by age 25 years.Estimated using modified Cox regression models
Outcome measures
| Measure |
IBD Cases
n=3898 Participants
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).
No specific intervention: Observational analysis of usual care only.
|
Matched Controls
n=15571 Participants
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.
No specific intervention: Observational analysis of usual care only.
|
|---|---|---|
|
Stream 1: Lifetime Risk of Developing a Mental Health Condition
|
31.1 percentage of participants analyzed
|
25.1 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: 5 years of follow-up.Relative risk of increased primary care visits in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression.
Outcome measures
| Measure |
IBD Cases
n=295 Participants
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).
No specific intervention: Observational analysis of usual care only.
|
Matched Controls
n=1648 Participants
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.
No specific intervention: Observational analysis of usual care only.
|
|---|---|---|
|
Stream 2: Relative Risk of Increased Primary Care Utilisation
|
12881 Count of prinary care interactions
|
58153 Count of prinary care interactions
|
SECONDARY outcome
Timeframe: 5 years of follow-up.Relative risk of increased hospital admissions in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression.
Outcome measures
| Measure |
IBD Cases
n=295 Participants
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).
No specific intervention: Observational analysis of usual care only.
|
Matched Controls
n=1648 Participants
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.
No specific intervention: Observational analysis of usual care only.
|
|---|---|---|
|
Stream 2: Relative Risk of Increased Hospital Admissions
|
339 Count of general hospital admissions
|
1295 Count of general hospital admissions
|
Adverse Events
People Diagnosed With Inflammatory Bowel Disease and Presence of a Mental Health Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
People Diagnosed With Inflammatory Bowel Disease and Absence of a Mental Health Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Richard K Russell
Royal Hospital for Children and Young People, Edinburgh
Phone: 0131 312 0431
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place