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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

19469 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-05

Study Completion Date

2023-08-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

IBDminds - Mapping the Influence of aNxiety and DepreSsion on IBD

NCT07175454

Inflammatory Bowel Diseases Mental Health Issue

NOT_YET_RECRUITING

Functional Gastrointestinal Disorders in Pediatric IBD

NCT03565263

Inflammatory Bowel Diseases Functional Gastrointestinal Disorders Pediatric Disorder +2 more

COMPLETED

Stress in Inflammatory Bowel Disease

NCT05202418

Inflammatory Bowel Diseases Psychological

COMPLETED NA

Digital Behavioral Interventions in Inflammatory Bowel Disease

NCT04861597

Crohn Disease Ulcerative Colitis Inflammatory Bowel Diseases +2 more

COMPLETED NA

An Online Intervention to Address Barriers to IBD Medication Adherence

NCT01852097

Inflammatory Bowel Disease (IBD)

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

* 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)