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

NCT05206734 | Completed Results DMC

• 1 other identifier: P043
• Study Type: observational
• Target: 19,469
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Stream 1: Lifetime Risk of Developing a Mental Health Condition

  Retrospective data assessed from 2010-2020, up to 10 years

• Stream 2: Relative Risk of Increased Primary Care Utilisation

  5 years of follow-up.

• Stream 2: Relative Risk of Increased Hospital Admissions

  5 years of follow-up.

Study Arms (4)

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

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

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

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

Interventions

No specific intervention OTHER

Observational analysis of usual care only.

IBD Cases; IBD cases with mental health condition; IBD cases without mental health condition; Matched Controls

Eligibility Criteria

• Age: 5 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• Momentum Data: lead
• Optimum Patient Care: collaborator

Study Sites (1)

Momentum Data Ltd

London, WC1X 8QT, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 38418244 DERIVED

• Cooney 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.

  PMID: 37603846 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Depressive Disorder; Anxiety Disorders; Mental Disorders; Self-Injurious Behavior; Suicide, Attempted; Feeding and Eating Disorders; Body Dysmorphic Disorders; Attention Deficit Disorder with Hyperactivity; Adjustment Disorders; Stress Disorders, Traumatic, Acute; Schizophrenia; Bipolar Disorder; Stress Disorders, Post-Traumatic; Parasomnias

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Mood Disorders; Behavioral Symptoms; Behavior; Suicide; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatoform Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Richard K Russell
• Organization: Royal Hospital for Children and Young People, Edinburgh

richard.russell@nhs.scot

0131 312 0431

Study Officials

• Andrew McGovern, MD

  Momentum Data

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 25, 2022
• Study Start: January 5, 2022
• Primary Completion: March 31, 2023
• Study Completion: August 15, 2023
• Last Updated: June 15, 2025
• Results First Posted: June 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available subject to approval for two years after the study publication date.
• Access Criteria: Data sharing is subject to ADEPT Committee approval.

Locations

GB (1)