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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05206734
• Other study ID #: P043
• Status: Completed
• Start date: January 5, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: August 2023
• Source: Momentum Data
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a large population-based analysis in the United Kingdom (UK) using routine primary care data to investigate the risk of mental health conditions in children, adolescents and young adults with Inflammatory Bowel Disease, compared to those without Inflammatory Bowel Disease. The study will also compare the impacts on quality-of-life outcomes and use of healthcare services between people with Inflammatory Bowel Disease with and without mental health conditions.

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 with a diagnosis of Inflammatory Bowel Disease, compared to matched population controls without a diagnosis of Inflammatory Bowel Disease. The secondary objective is to determine the severity of mental health outcomes in those with and without a diagnosis of Inflammatory Bowel Disease. Stream 2 primary objective is to determine the impact of mental health conditions in children, adolescents and young adults with Inflammatory Bowel Disease 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 Inflammatory Bowel Disease severity, such as medication use, surgical intervention, nutritional supplement prescriptions and markers of nutritional status including underweight or growth retardation in children and adolescents, between those with and without mental health conditions. Then to compare healthcare resource utilisation in children, adolescents and young adults with Inflammatory Bowel Disease with and without mental health conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19469
• Est. completion date: August 15, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Stress Disorder
• Adjustment Disorders
• Anxiety Disorder
• Anxiety Disorders
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Behavioral Disorder
• Bipolar Disorder
• Body Dysmorphic Disorders
• Body Image Disorder
• Depressive Disorder
• Depressive Episode
• Eating Disorders
• Feeding and Eating Disorders
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Mental Disorders
• Parasuicide
• Post-traumatic Stress Disorder
• Psychological Disorder
• Recurrent Depressive Disorder
• Schizophrenia
• Self Harm
• Sleep Disturbance
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Stress Disorders, Traumatic, Acute
• Suicide
• Suicide, Attempted

Intervention

Other:
• Exposure of mental health condition
Primary: Composite of all chronic psychological conditions (depression, anxiety, eating disorders, body image disorders, attention-deficit disorder, behavioural disorders, adjustment disorder, acute stress disorder, and post-traumatic stress disorder). Major recurrent depression or treated depressive episode. Non-phobia related anxiety episode or disorder. Secondary: Self-harm, suicide attempt or suicide related codes, other chronic psychiatric conditions (eating disorders, body image disorders, attention-deficit disorder, behavioural disorders, adjustment disorders, acute stress disorder, schizophrenia, bipolar disorder and post-traumatic stress disorder. Problems with sleep.

Locations

Country	Name	City	State
United Kingdom	Momentum Data Ltd	London

Sponsors (2)

Lead Sponsor	Collaborator
Momentum Data	Optimum Patient Care

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stream 1 - Primary Outcome: Prevalence and cumulative incidence of mental health conditions in children, adolescents and young adults with IBD	Using routinely collected information from patient electronic medical record (EMR) data, we will investigate the prevalence and cumulative incidence of each mental health condition in cases with a diagnosis of IBD and controls without a diagnosis of IBD. Prevalence and cumulative incidence will be stratified by IBD type (Ulcerative Colitis, Crohn's Disease or IBD Unclassified). IBD classification status and mental health conditions will be identified on the basis diagnosis codes within their EMR.	Date of Inflammatory Bowel Disease diagnosis for cases or for controls date of diagnosis for their matched counterpart. End of follow-up will be the first of; point of data extraction, patients 25th birthday or loss to follow-up.
Primary	Stream 2 - Primary Outcome: Impact of mental health conditions in children, adolescents and young adults with IBD	Determine the association between mental health conditions in children, adolescents and young adults with Inflammatory Bowel Disease on quality-of-life indicators. These indicators will be gathered from the routinely collected EMR data, such as records for absence from work or school, unemployment, sleep disturbance and substance abuse.	Index date of 01/01/2015 with 5 years of follow-up.
Secondary	Stream 1 - Secondary outcome: Sequelae of mental health conditions in children, adolescents and young adults with IBD	Determine the sequelae of mental health conditions in people with and without Inflammatory Bowel Disease. Mental health disease information will be gathered from routinely collected EMR data using diagnosis codes for a range of mental health conditions, comprising of three core phenotypes: anxiety/panic disorders, major depressive disorders or depressive episodes, and other psychological conditions. Mental health condition sequelae will include any coded episode of self-harm or suicide, the development of additional chronic mental health conditions, and recorded sleep disturbance.	Date of Inflammatory Bowel Disease diagnosis for cases or for controls date of diagnosis for their matched counterpart. End of follow-up will be the first of; point of data extraction, patients 25th birthday or loss to follow-up.
Secondary	Stream 2 - Secondary outcome - IBD severity markers	Compare indicators of IBD severity in children, adolescents and young adults with and without mental health conditions. Indicators for disease severity will be gathered from the routinely collected EMR data, including records for medication use, surgical intervention, nutritional supplement prescriptions and markers of nutritional status including records of underweight or codes for growth retardation in children and adolescents, between those with and without mental health conditions.	Index date of 01/01/2015 with up to 5 years of follow-up.
Secondary	Stream 2 - Secondary outcome - Healthcare utilisation	Compare healthcare resource utilisation in children, adolescents and young adults with Inflammatory Bowel Disease with and without mental health conditions. Healthcare resource utilisation will comprise of records of number of primary care contacts and primary care records reporting hospital admission. Hospital admission will be separated into general admission (including for IBD) and psychiatric admission.	Index date of 01/01/2015 with up to 5 years of follow-up.