Risk of Mental Health Conditions in Children and Young Adults With Inflammatory Bowel Disease and Influence on Health

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Inflammatory Bowel Diseases; Bipolar Disorder; Sleep Disturbance; Suicide, Attempted; Attention Deficit Hyperactivity Disorder; Post-traumatic Stress Disorder; Self Harm; Body Image Disorder; Eating Disorders; Adjustment Disorders; Anxiety Disorder; Depressive Episode; Behavioral Disorder; Psychological Disorder; Recurrent Depressive Disorder; Acute Stress Disorder; Parasuicide
• Intervention / Treatment: Other: No specific intervention

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 Type: Observational
• Enrollment (Actual): 19469

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, WC1X 8QT
    • Momentum Data Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Cases of IBD in childhood and young adults and age, gender and GP matched controls.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Other: 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 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; Observational analysis of usual care only.
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	Other: No specific intervention; Observational analysis of usual care only.
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	Other: No specific intervention; Observational analysis of usual care only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	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.	5 years of follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	5 years of follow-up.

Collaborators and Investigators

• Sponsor: Momentum Data
• Collaborators: Optimum Patient Care
• Investigators: Principal Investigator: Andrew McGovern, MD, Momentum Data

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: May 29, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Bipolar and Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Behavioral Symptoms; Digestive System Diseases; Gastrointestinal Diseases; Self-Injurious Behavior; Mood Disorders; Gastroenteritis; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Suicide; Somatoform Disorders; Schizophrenia; Anxiety Disorders; Depressive Disorder; Bipolar Disorder; Mental Disorders; Intestinal Diseases; Attention Deficit Disorder with Hyperactivity; Inflammatory Bowel Diseases; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Feeding and Eating Disorders; Stress Disorders, Traumatic, Acute; Adjustment Disorders; Suicide, Attempted; Body Dysmorphic Disorders
• Other Study ID Numbers: P043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The data will be available subject to approval for two years after the study publication date.
• IPD Sharing Access Criteria: Data sharing is subject to ADEPT Committee approval.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No