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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.


Clinical Trial 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. ;


Study Design


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
  • Disease
  • Eating Disorders
  • Feeding and Eating Disorders
  • Inflammatory Bowel Diseases
  • Intestinal Diseases
  • Mental Disorders
  • Parasuicide
  • Post-traumatic Stress Disorder
  • Problem Behavior
  • Psychological Disorder
  • Recurrent Depressive Disorder
  • Schizophrenia
  • Self Harm
  • Sleep Disturbance
  • Stress Disorders, Post-Traumatic
  • Stress Disorders, Traumatic
  • Stress Disorders, Traumatic, Acute
  • Suicide
  • Suicide, Attempted

NCT number NCT05206734
Study type Observational
Source Momentum Data
Contact
Status Active, not recruiting
Phase
Start date January 5, 2022
Completion date December 1, 2022

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