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Completed

NCT Number: NCT05206734

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

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.

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Key information

Conditions

Inflammatory Bowel Diseases Acute Stress Disorder Adjustment Disorders Anxiety Disorder Anxiety Disorders Attention Deficit Disorder with Hyperactivity Attention Deficit Hyperactivity Disorder Attention Deficit and Disruptive Behavior Disorders Behavior Behavioral Disorder Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Body Dysmorphic Disorders Body Image Disorder Depressive Disorder Depressive Episode Digestive System Diseases Eating Disorders Feeding and Eating Disorders Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Mental Disorders Mood Disorders Nervous System Diseases Neurodevelopmental Disorders Parasomnias Parasuicide Pathological Conditions, Signs and Symptoms Post-traumatic Stress Disorder Psychological Disorder Recurrent Depressive Disorder Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Self Harm Self-Injurious Behavior Signs and Symptoms Signs and Symptoms, Digestive Sleep Disturbance Sleep Wake Disorders Somatoform Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Stress Disorders, Traumatic, Acute Suicide Suicide, Attempted Trauma and Stressor Related Disorders

Age range

5 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Momentum Data Ltd

London, WC1X 8QT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No specific intervention

Other

Observational analysis of usual care only.

Primary outcomes

  1. Stream 1: Percentage of Participants Who Developed Any Mental Health Condition

    Time frame: 5 years

    Cumulative incidence (percentage of participants in each arm who developed any mental health condition) was calculated using Kaplan-Meier analysis

  2. Stream 1: Relative Risk of Any Mental Health Condition

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

    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.

  3. Stream 2: Relative Risk of Bowel Symptoms (Quality of Life Indicator)

    Time frame: 5 years of follow-up.

    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.

  4. Stream 2: Relative Risk of Sleep Disturbance (Quality of Life Indicator)

    Time frame: 5 years of follow-up.

    Relative risk in participants with mental health conditions compared with those without MH conditions. Calculated using Cox regression.

  5. Stream 2: Relative Risk of Low Mood (Emotional Function)

    Time frame: 5 years of follow-up.

    Relative risk in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression.

Secondary outcomes

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

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

    Probability of developing a mental health condition by age 25 years.Estimated using modified Cox regression models

  2. Stream 2: Relative Risk of Increased Primary Care Utilisation

    Time frame: 5 years of follow-up.

    Relative risk of increased primary care visits in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression.

  3. Stream 2: Relative Risk of Increased Hospital Admissions

    Time frame: 5 years of follow-up.

    Relative risk of increased hospital admissions in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression.

Sponsors and collaborators

Lead sponsor

Momentum Data

Industry

Collaborators

  • Optimum Patient Care

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 25, 2022
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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