Trial · NCT05206734
Risk of Mental Health Conditions in Children and Young Adults With Inflammatory Bowel Disease and Influence on Health
NCT05206734, Completed, Momentum Data; results first posted 2025-06-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Risk of Mental Health Conditions in Children and Young Adults With Inflammatory Bowel Disease and Influence on Health. Trials, record NCT05206734. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05206734
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Risk of Mental Health Conditions in Children and Young Adults With Inflammatory Bowel Disease and Influence on Health
- NCT number
- NCT05206734
- Status
- Completed
- Enrollment
- 19,469 participants, actual
- Lead sponsor
- Momentum Data
- 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
- Interventions
- No specific intervention
- First posted
- 2022-01-25
- Last updated
- 2025-06-15
- Results first posted
- 2025-06-15
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Stream 1: Percentage of Participants Who Developed Any Mental Health Condition | 5 years | Cumulative incidence (percentage of participants in each arm who developed any mental health condition) was calculated using Kaplan-Meier analysis |
| Primary | Stream 1: Relative Risk of Any Mental Health Condition | 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. |
| Primary | Stream 2: Relative Risk of Bowel Symptoms (Quality of Life Indicator) | 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. |
| Primary | Stream 2: Relative Risk of Sleep Disturbance (Quality of Life Indicator) | 5 years of follow-up. | Relative risk in participants with mental health conditions compared with those without MH conditions. Calculated using Cox regression. |
| Primary | Stream 2: Relative Risk of Low Mood (Emotional Function) | 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 | Stream 1: Lifetime Risk of Developing a Mental Health Condition | 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 |
| Secondary | Stream 2: Relative Risk of Increased Primary Care Utilisation | 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. |
| Secondary | Stream 2: Relative Risk of Increased Hospital Admissions | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Stream 1: Percentage of Participants Who Developed Any Mental Health Condition | 5 years | Participants with a pre-existing diagnosis of mental health were excluded | percentage of participants | NUMBER |
| PRIMARY | Stream 1: Relative Risk of Any Mental Health Condition | Retrospective data assessed from 2010-2020, up to 10 years | Participants with a pre-existing diagnosis of mental health were excluded | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Stream 2: Relative Risk of Bowel Symptoms (Quality of Life Indicator) | 5 years of follow-up. | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Stream 2: Relative Risk of Sleep Disturbance (Quality of Life Indicator) | 5 years of follow-up. | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Stream 2: Relative Risk of Low Mood (Emotional Function) | 5 years of follow-up. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Stream 1: Lifetime Risk of Developing a Mental Health Condition | Retrospective data assessed from 2010-2020, up to 10 years | percentage of participants analyzed | NUMBER | |
| SECONDARY | Stream 2: Relative Risk of Increased Primary Care Utilisation | 5 years of follow-up. | Count of prinary care interactions | NUMBER | |
| SECONDARY | Stream 2: Relative Risk of Increased Hospital Admissions | 5 years of follow-up. | Count of general hospital admissions | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Stream 1: Percentage of Participants Who Developed Any Mental Health Condition | IBD Cases | 12.0 | 95% Confidence Interval 10.5 to 13.4 | percentage of participants | |
| Stream 1: Percentage of Participants Who Developed Any Mental Health Condition | Matched Controls | 9.4 | 95% Confidence Interval 8.7 to 10.1 | percentage of participants | |
| Stream 1: Relative Risk of Any Mental Health Condition | IBD Cases | 299 | Participants | ||
| Stream 1: Relative Risk of Any Mental Health Condition | Matched Controls (Reference Group) | 811 | Participants | ||
| Stream 2: Relative Risk of Bowel Symptoms (Quality of Life Indicator) | IBD Cases With Mental Health Condition | 148 | Participants | ||
| Stream 2: Relative Risk of Bowel Symptoms (Quality of Life Indicator) | IBD Cases Without Mental Health Condition (Reference Group) | 473 | Participants | ||
| Stream 2: Relative Risk of Sleep Disturbance (Quality of Life Indicator) | IBD Cases With Mental Health Condition | 26 | Participants | ||
| Stream 2: Relative Risk of Sleep Disturbance (Quality of Life Indicator) | IBD Cases Without Mental Health Condition (Reference Group) | 83 | Participants | ||
| Stream 2: Relative Risk of Low Mood (Emotional Function) | IBD Cases With Mental Health Condition | 63 | Participants | ||
| Stream 2: Relative Risk of Low Mood (Emotional Function) | IBD Cases Without Mental Health Condition (Reference Group) | 119 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IBD Cases | 3,898 | |
| Overall Study | STARTED | Matched Controls | 15,571 | |
| Overall Study | IBD Cases With Mental Health Condition | IBD Cases | 295 | |
| Overall Study | IBD Cases With Mental Health Condition | Matched Controls | 0 | |
| Overall Study | IBD Cases Without Mental Health Condition | IBD Cases | 1,648 | |
| Overall Study | IBD Cases Without Mental Health Condition | Matched Controls | 0 | |
| Overall Study | COMPLETED | IBD Cases | 3,898 | |
| Overall Study | COMPLETED | Matched Controls | 15,571 | |
| Overall Study | NOT COMPLETED | IBD Cases | 0 | |
| Overall Study | NOT COMPLETED | Matched Controls | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | People Diagnosed With Inflammatory Bowel Disease and Presence of a Mental Health Condition | 0 | 0 |
| Total, all-cause mortality | People Diagnosed With Inflammatory Bowel Disease and Absence of a Mental Health Condition | 0 | 0 |
| Total, other adverse events | People Diagnosed With Inflammatory Bowel Disease and Presence of a Mental Health Condition | 0 | 0 |
| Total, other adverse events | People Diagnosed With Inflammatory Bowel Disease and Absence of a Mental Health Condition | 0 | 0 |
| Total, serious adverse events | People Diagnosed With Inflammatory Bowel Disease and Presence of a Mental Health Condition | 0 | 0 |
| Total, serious adverse events | People Diagnosed With Inflammatory Bowel Disease and Absence of a Mental Health Condition | 0 | 0 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| IBD Cases With Mental Health Condition vs IBD Cases Without Mental Health Condition (Reference Group): Stream 2: Relative Risk of Bowel Symptoms (Quality of Life Indicator) | Trial comparisons |
| IBD Cases With Mental Health Condition vs IBD Cases Without Mental Health Condition (Reference Group): Stream 2: Relative Risk of Low Mood (Emotional Function) | Trial comparisons |
| IBD Cases With Mental Health Condition vs IBD Cases Without Mental Health Condition (Reference Group): Stream 2: Relative Risk of Sleep Disturbance (Quality of Life Indicator) | Trial comparisons |
| IBD Cases vs Matched Controls (Reference Group): Stream 1: Relative Risk of Any Mental Health Condition | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05206734
GET https://conductscience.org/api/trials/v1/NCT05206734/registered