NCT05206734

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 19,469 (actual)
• Sponsor: Momentum Data · Industry
• Sex: All
• Age: 5 Years – 25 Years
• Healthy volunteers: Accepted

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.

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
• Suicide, Attempted
• Parasuicide
• Eating Disorders
• Body Image Disorder
• Attention Deficit Hyperactivity Disorder
• Behavioral Disorder
• Adjustment Disorders
• Acute Stress Disorder
• Schizophrenia
• Bipolar Disorder
• Post-traumatic Stress Disorder
• Sleep Disturbance

Interventions

Type	Name	Description
OTHER	No specific intervention	Observational analysis of usual care only.

Timeline

• Start date: 2022-01-05
• Primary completion: 2023-03-31
• Completion: 2023-08-15
• First posted: 2022-01-25
• Last updated: 2025-06-15
• Results posted: 2025-06-15

Locations

1 site across 1 country: United Kingdom