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

Momentum Data

Status: Completed

Conditions: Acute Stress Disorder; Post-traumatic Stress Disorder; Attention Deficit Hyperactivity Disorder; Psychological Disorder; Bipolar Disorder; Eating Disorders; Parasuicide; Anxiety Disorder; Recurrent Depressive Disorder; Self Harm; Adjustment Disorders; Suicide, Attempted; Schizophrenia; Sleep Disturbance; Depressive Episode; Inflammatory Bowel Diseases; Behavioral Disorder; Body Image Disorder

Treatments: Other: No specific intervention

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05206734

P043

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19,469 patients

Sex: All

Ages: 5 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

19,469 participants in 4 patient groups

IBD Cases

Description:

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).

Treatment:

Other: No specific intervention

Matched Controls

Description:

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.

Treatment:

Other: No specific intervention

IBD cases with mental health condition

Description:

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

Treatment:

Other: No specific intervention

IBD cases without mental health condition

Description:

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

Treatment:

Other: No specific intervention