Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-30 @ 6:50 PM
Study NCT ID:
NCT05206734
Status:
COMPLETED
Last Update Posted:
2025-06-15
First Post:
2022-01-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Risk of Mental Health Conditions in Children and Young Adults With Inflammatory Bowel Disease and Influence on Health
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D013406', 'term': 'Suicide, Attempted'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D057215', 'term': 'Body Dysmorphic Disorders'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D000275', 'term': 'Adjustment Disorders'}, {'id': 'D040701', 'term': 'Stress Disorders, Traumatic, Acute'}, {'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D013405', 'term': 'Suicide'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'richard.russell@nhs.scot', 'phone': '0131 312 0431', 'title': 'Richard K Russell', 'organization': 'Royal Hospital for Children and Young People, Edinburgh'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'deaths, serious adverse events, and nonserious adverse events were not assessed for study participants', 'eventGroups': [{'id': 'EG000', 'title': 'People Diagnosed With Inflammatory Bowel Disease and Presence of a Mental Health Condition', 'description': "Children, adolescents and young adults (aged 5- 25 years) diagnosed with Inflammatory Bowel Disease (IBD); comprising of Ulcerative Colitis, Crohn's Disease and Unclassified IBD and presence of a diagnosis of a mental health condition.\n\nMental health condition comprises 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.", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'People Diagnosed With Inflammatory Bowel Disease and Absence of a Mental Health Condition', 'description': "Children, adolescents and young adults (aged 5- 25 years) diagnosed with Inflammatory Bowel Disease (IBD); comprising of Ulcerative Colitis, Crohn's Disease and Unclassified IBD and absence of a diagnosis of a mental health condition.\n\nMental health condition comprises 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.", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stream 1: Percentage of Participants Who Developed Any Mental Health Condition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3423', 'groupId': 'OG000'}, {'value': '12256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '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).\n\nNo specific intervention: Observational analysis of usual care only."}, {'id': 'OG001', 'title': '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.\n\nNo specific intervention: Observational analysis of usual care only.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '13.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '8.7', 'upperLimit': '10.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Cumulative incidence (percentage of participants in each arm who developed any mental health condition) was calculated using Kaplan-Meier analysis', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with a pre-existing diagnosis of mental health were excluded'}, {'type': 'PRIMARY', 'title': 'Stream 1: Relative Risk of Any Mental Health Condition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3423', 'groupId': 'OG000'}, {'value': '12256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '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).\n\nNo specific intervention: Observational analysis of usual care only."}, {'id': 'OG001', 'title': 'Matched Controls (Reference Group)', '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.\n\nNo specific intervention: Observational analysis of usual care only.'}], 'classes': [{'categories': [{'measurements': [{'value': '299', 'groupId': 'OG000'}, {'value': '811', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '1.12', 'ciUpperLimit': '1.46', 'estimateComment': 'HR was calculated using a Cox Proportional Hazard model adjusted for age,sex,socioeconomic status, ethnicity and common childhood conditions. Reflects a comparison of the incidence rates between participants diagnosed with IBD and those without IBD.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Retrospective data assessed from 2010-2020, up to 10 years', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with a pre-existing diagnosis of mental health were excluded'}, {'type': 'PRIMARY', 'title': 'Stream 2: Relative Risk of Bowel Symptoms (Quality of Life Indicator)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '1648', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '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\n\nNo specific intervention: Observational analysis of usual care only.'}, {'id': 'OG001', 'title': 'IBD Cases Without Mental Health Condition (Reference Group)', '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\n\nNo specific intervention: Observational analysis of usual care only.'}], 'classes': [{'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.82', 'ciLowerLimit': '1.33', 'ciUpperLimit': '2.52', 'estimateComment': 'RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years of follow-up.', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Stream 2: Relative Risk of Sleep Disturbance (Quality of Life Indicator)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '1648', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '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\n\nNo specific intervention: Observational analysis of usual care only.'}, {'id': 'OG001', 'title': 'IBD Cases Without Mental Health Condition (Reference Group)', '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\n\nNo specific intervention: Observational analysis of usual care only.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.63', 'ciLowerLimit': '1.02', 'ciUpperLimit': '2.62', 'estimateComment': 'HR calculated using Cox regression models adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years of follow-up.', 'description': 'Relative risk in participants with mental health conditions compared with those without MH conditions. Calculated using Cox regression.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Stream 2: Relative Risk of Low Mood (Emotional Function)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '1648', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '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\n\nNo specific intervention: Observational analysis of usual care only.'}, {'id': 'OG001', 'title': 'IBD Cases Without Mental Health Condition (Reference Group)', '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\n\nNo specific intervention: Observational analysis of usual care only.'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.78', 'ciLowerLimit': '1.76', 'ciUpperLimit': '4.43', 'estimateComment': 'RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years of follow-up.', 'description': 'Relative risk in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stream 1: Lifetime Risk of Developing a Mental Health Condition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3898', 'groupId': 'OG000'}, {'value': '15571', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '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).\n\nNo specific intervention: Observational analysis of usual care only."}, {'id': 'OG001', 'title': '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.\n\nNo specific intervention: Observational analysis of usual care only.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000'}, {'value': '25.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Retrospective data assessed from 2010-2020, up to 10 years', 'description': 'Probability of developing a mental health condition by age 25 years.Estimated using modified Cox regression models', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stream 2: Relative Risk of Increased Primary Care Utilisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '1648', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '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\n\nNo specific intervention: Observational analysis of usual care only.'}, {'id': 'OG001', 'title': 'IBD Cases Without Mental Health Condition (Reference Group)', '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\n\nNo specific intervention: Observational analysis of usual care only.'}], 'classes': [{'categories': [{'measurements': [{'value': '12881', 'groupId': 'OG000'}, {'value': '58153', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '1.12', 'ciUpperLimit': '1.58', 'estimateComment': 'RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '5 years of follow-up.', 'description': 'Relative risk of increased primary care visits in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression.', 'unitOfMeasure': 'Count of prinary care interactions', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stream 2: Relative Risk of Increased Hospital Admissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '1648', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '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\n\nNo specific intervention: Observational analysis of usual care only.'}, {'id': 'OG001', 'title': 'IBD Cases Without Mental Health Condition (Reference Group)', '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\n\nNo specific intervention: Observational analysis of usual care only.'}], 'classes': [{'categories': [{'measurements': [{'value': '339', 'groupId': 'OG000'}, {'value': '1295', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.87', 'ciLowerLimit': '1.29', 'ciUpperLimit': '2.75', 'estimateComment': 'RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '5 years of follow-up.', 'description': 'Relative risk of increased hospital admissions in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression.', 'unitOfMeasure': 'Count of general hospital admissions', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '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).\n\nNo specific intervention: Observational analysis of usual care only."}, {'id': 'FG001', 'title': '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 United Kingdom (UK) census categories: White, Asian, Black, Mixed, Other), index of multiple deprivation based on postcode, and by practice where numbers allow.\n\nNo specific intervention: Observational analysis of usual care only.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3898'}, {'groupId': 'FG001', 'numSubjects': '15571'}]}, {'type': 'IBD Cases With Mental Health Condition', 'achievements': [{'groupId': 'FG000', 'numSubjects': '295'}, {'comment': 'Study exposure category: IBD, with or without mental health comorbidity excludes matched controls without IBD', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'IBD Cases Without Mental Health Condition', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1648'}, {'comment': 'Study exposure category: IBD, with or without mental health comorbidity excludes matched controls without IBD', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3898'}, {'groupId': 'FG001', 'numSubjects': '15571'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3898', 'groupId': 'BG000'}, {'value': '15571', 'groupId': 'BG001'}, {'value': '19469', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '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).\n\nNo specific intervention: Observational analysis of usual care only."}, {'id': 'BG001', 'title': '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.\n\nNo specific intervention: Observational analysis of usual care only.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000', 'lowerLimit': '15', 'upperLimit': '21'}, {'value': '19', 'groupId': 'BG001', 'lowerLimit': '15', 'upperLimit': '21'}, {'value': '19', 'groupId': 'BG002', 'lowerLimit': '15', 'upperLimit': '21'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age subgroup', 'categories': [{'title': '5-11 years', 'measurements': [{'value': '364', 'groupId': 'BG000'}, {'value': '1466', 'groupId': 'BG001'}, {'value': '1830', 'groupId': 'BG002'}]}, {'title': '12-17 years', 'measurements': [{'value': '1178', 'groupId': 'BG000'}, {'value': '4684', 'groupId': 'BG001'}, {'value': '5862', 'groupId': 'BG002'}]}, {'title': '18-25 years', 'measurements': [{'value': '2356', 'groupId': 'BG000'}, {'value': '9421', 'groupId': 'BG001'}, {'value': '11777', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1819', 'groupId': 'BG000'}, {'value': '7262', 'groupId': 'BG001'}, {'value': '9081', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2079', 'groupId': 'BG000'}, {'value': '8309', 'groupId': 'BG001'}, {'value': '10388', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian or Asian British', 'measurements': [{'value': '276', 'groupId': 'BG000'}, {'value': '1000', 'groupId': 'BG001'}, {'value': '1276', 'groupId': 'BG002'}]}, {'title': 'Black or Black British', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1963', 'groupId': 'BG000'}, {'value': '7536', 'groupId': 'BG001'}, {'value': '9499', 'groupId': 'BG002'}]}, {'title': 'Mixed', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}, {'title': 'Not stated', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '703', 'groupId': 'BG001'}, {'value': '886', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '548', 'groupId': 'BG001'}, {'value': '721', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '1218', 'groupId': 'BG000'}, {'value': '5472', 'groupId': 'BG001'}, {'value': '6690', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Ethnicity was categorized to be consistent with the UK official census categories.', 'unitOfMeasure': 'Participants'}, {'title': 'Deprivation quintile', 'classes': [{'categories': [{'title': '1 (most deprived)', 'measurements': [{'value': '243', 'groupId': 'BG000'}, {'value': '1019', 'groupId': 'BG001'}, {'value': '1262', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '749', 'groupId': 'BG000'}, {'value': '2973', 'groupId': 'BG001'}, {'value': '3722', 'groupId': 'BG002'}]}, {'title': '3', 'measurements': [{'value': '1172', 'groupId': 'BG000'}, {'value': '4623', 'groupId': 'BG001'}, {'value': '5795', 'groupId': 'BG002'}]}, {'title': '4', 'measurements': [{'value': '1193', 'groupId': 'BG000'}, {'value': '4811', 'groupId': 'BG001'}, {'value': '6004', 'groupId': 'BG002'}]}, {'title': '5 (least deprived)', 'measurements': [{'value': '209', 'groupId': 'BG000'}, {'value': '847', 'groupId': 'BG001'}, {'value': '1056', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '332', 'groupId': 'BG000'}, {'value': '1298', 'groupId': 'BG001'}, {'value': '1630', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Defined using Index of Multiple Deprivation (IMD) derived from the patient's postcode at the point of data extraction.IMD is a measures of relative deprivation.", 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-24', 'size': 946140, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-26T05:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19469}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2022-01-10', 'resultsFirstSubmitDate': '2025-01-29', 'studyFirstSubmitQcDate': '2022-01-24', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-29', 'studyFirstPostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stream 1: Percentage of Participants Who Developed Any Mental Health Condition', 'timeFrame': '5 years', 'description': 'Cumulative incidence (percentage of participants in each arm who developed any mental health condition) was calculated using Kaplan-Meier analysis'}, {'measure': 'Stream 1: Relative Risk of Any Mental Health Condition', 'timeFrame': 'Retrospective data assessed from 2010-2020, up to 10 years', 'description': '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.'}, {'measure': 'Stream 2: Relative Risk of Bowel Symptoms (Quality of Life Indicator)', 'timeFrame': '5 years of follow-up.', 'description': '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.'}, {'measure': 'Stream 2: Relative Risk of Sleep Disturbance (Quality of Life Indicator)', 'timeFrame': '5 years of follow-up.', 'description': 'Relative risk in participants with mental health conditions compared with those without MH conditions. Calculated using Cox regression.'}, {'measure': 'Stream 2: Relative Risk of Low Mood (Emotional Function)', 'timeFrame': '5 years of follow-up.', 'description': 'Relative risk in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression.'}], 'secondaryOutcomes': [{'measure': 'Stream 1: Lifetime Risk of Developing a Mental Health Condition', 'timeFrame': 'Retrospective data assessed from 2010-2020, up to 10 years', 'description': 'Probability of developing a mental health condition by age 25 years.Estimated using modified Cox regression models'}, {'measure': 'Stream 2: Relative Risk of Increased Primary Care Utilisation', 'timeFrame': '5 years of follow-up.', 'description': 'Relative risk of increased primary care visits in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression.'}, {'measure': 'Stream 2: Relative Risk of Increased Hospital Admissions', 'timeFrame': '5 years of follow-up.', 'description': 'Relative risk of increased hospital admissions in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['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']}, 'referencesModule': {'references': [{'pmid': '38418244', 'type': 'DERIVED', 'citation': 'Cooney R, Barrett K, Russell RK. Impact of mental health comorbidity in children and young adults with inflammatory bowel disease: a UK population-based cohort study. BMJ Open. 2024 Feb 28;14(2):e080408. doi: 10.1136/bmjopen-2023-080408.'}, {'pmid': '37603846', 'type': 'DERIVED', 'citation': 'Cooney R, Tang D, Barrett K, Russell RK. Children and Young Adults With Inflammatory Bowel Disease Have an Increased Incidence and Risk of Developing Mental Health Conditions: A UK Population-Based Cohort Study. Inflamm Bowel Dis. 2024 Aug 1;30(8):1264-1273. doi: 10.1093/ibd/izad169.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This study will use routinely electronic medical record (EMR) data from primary care practices within the Optimum Patient Care Research Database (OPCRD).\n\nStream 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.\n\nStream 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cases of IBD in childhood and young adults and age, gender and GP matched controls.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 5 years and 25 years\n* 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\n* A recorded diagnosis of IBD in the clinical record (cases)\n\nExclusion Criteria:\n\n• None'}, 'identificationModule': {'nctId': 'NCT05206734', 'briefTitle': 'Risk of Mental Health Conditions in Children and Young Adults With Inflammatory Bowel Disease and Influence on Health', 'organization': {'class': 'INDUSTRY', 'fullName': 'Momentum Data'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'P043'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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).", 'interventionNames': ['Other: No specific intervention']}, {'label': '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.', 'interventionNames': ['Other: No specific intervention']}, {'label': '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', 'interventionNames': ['Other: No specific intervention']}, {'label': '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', 'interventionNames': ['Other: No specific intervention']}], 'interventions': [{'name': 'No specific intervention', 'type': 'OTHER', 'description': 'Observational analysis of usual care only.', 'armGroupLabels': ['IBD Cases', 'IBD cases with mental health condition', 'IBD cases without mental health condition', 'Matched Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WC1X 8QT', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Momentum Data Ltd', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Andrew McGovern, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Momentum Data'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'The data will be available subject to approval for two years after the study publication date.', 'ipdSharing': 'YES', 'description': 'OPCRD data can be access by bone fide researchers for specific research projects subject to approval by Anonymised Data Ethics \\& Protocol Transparency (ADEPT) Committee. The data used for this study cannot be made available without such approval.', 'accessCriteria': 'Data sharing is subject to ADEPT Committee approval.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Momentum Data', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Optimum Patient Care', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}