Inflammatory Bowel DiseasesNCT06429488
Obsessive-compulsive Disorder, Depression and Anxiety Among Patients With Crohn's Disease
An observational study of Inflammatory Bowel Diseases, run by University of Jordan at 1 site in Jordan.
Trial summary
Introduction: Crohn's disease (CD) and obsessive-compulsive disorder (OCD) are two distinct medical conditions that affect millions of people worldwide. While numerous studies have explored anxiety and depression in CD, there is a notable lack of research about the link between OCD and CD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 293 participants
- Where
- 1 siteJordan
- Study dates
- 1 Sep 2022to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: This is an observational case-control study was conducted at Jordan University Hospital, Using hospital medical records, patients with Crohn's disease who been treated and followed up at the gastro-enterology and colorectal clinics were contacted to obtain their consent to participate in the research and to explain its goals and the nature of the questionnaires used. Patients who agreed to participate were sent an online questionnaire to fill in. Healthy Controls with no medical illness or mental illness before were invited to fill in the same questionnaire, the controls where relatives of patients attending the hospital for clinics not related to the gastrointestinal tract or psychiatry. Patients and controls with documented psychiatric illnesses were excluded.
Who may be able to join
- Patients diagnosed with Crohn's disease who have been treated and followed up at the gastro-enterology and colorectal clinics of Jordan University Hospital.
- Patients who have provided informed consent to participate in the research after being informed about the study's goals and the nature of the questionnaires used.
- Healthy controls with no prior history of medical or mental illness.
- Controls who are relatives of patients attending non-gastroenterology and non-psychiatry clinics at Jordan University Hospital.
- Participants (both patients and healthy controls) who agree to fill in the online questionnaire.
Who cannot join
- Patients and controls with documented psychiatric illnesses.
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: Crohn's disease (CD) and obsessive-compulsive disorder (OCD) are two distinct medical conditions that affect millions of people worldwide. While numerous studies have explored anxiety and depression in CD, there is a notable lack of research about the link between OCD and CD. The aim of the study is to look for a relation between these seemingly unrelated conditions.
Methods: Patients with a diagnosis of Crohn's disease were given four different questionnaires in order to assess for the presence of obsessive-compulsive disorder, depression, and anxiety symptoms using the OCI-R score, DASS-21, PHQ-9, and GAD-7. The same questionnaires were used to assess healthy controls for similar symptoms.
Read the detailed description
This is an observational case-control study conducted at Jordan University Hospital. Using hospital medical records, patients with Crohn's disease who had been treated and followed up at the gastro-enterology and colorectal clinics were contacted to obtain consent to participate in the research and to explain its goals and the nature of the questionnaires used. Patients who agreed to participate were sent an online questionnaire to fill in. Healthy Controls with no medical illness or mental illness were invited to fill in the same questionnaire. The controls were relatives of patients attending the hospital for clinics not related to the gastrointestinal tract or psychiatry. Patients and controls with documented psychiatric illnesses were excluded.
The following psychological assessment tools were used:
The Obsessive-Compulsive Inventory-Revised (OCI-R) for obsessive-compulsive symptoms. It is composed of an 18-item self-report validated questionnaire that measures symptoms across 6 subscales including washing, checking, neutralizing, obsessing, ordering, and hoarding. The possible range of scores is 0-72.
The Depression Anxiety Stress Scales-21 (DASS-21) for overall emotional well-being. It is a set of three self-report scales to understand the degree of stress and distress, depressive and anxiety symptoms. The shortened version was used, which consists of 21 items and has been widely used for research and clinical purposes and is easy to administer.
The Patient Health Questionnaire-9 (PHQ-9), a nine-item depression scale of the patient health questionnaire, to assess depressive symptoms. The individual responses are interpreted as a score, with depression divided from no depression to severe depression.
The Generalized Anxiety Disorder-7 (GAD-7), a seven-item tool used to measure or assess anxiety symptoms and the severity of generalized anxiety disorder (GAD).
Data analysis:
The data was collected using Microsoft Forms and downloaded into Excel for coding and deidentification before being imported into the Statistical Package for Social Science (IBM SPSS Statistics for Windows, version 25, IBM Corp., Armonk, N.Y., USA) for analysis. The chi-square test was used to compare different categorical variables. The Mann-Whitney U test was used to compare non-categorical variables. The Kruskal-Wallis test was applied to test for significant differences between the scales.
Ethical consideration:
This study adhered to the principles of the Declaration of Helsinki 1975 and was approved by the Institutional Review Board at Jordan University Hospital.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- no intervention, questionnaires were used
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention, questionnaires were usedOther
The following psychological assessment tools were used:
Obsessive-Compulsive Inventory-Revised (OCI-R): An 18-item self-report questionnaire measuring symptoms across six subscales: washing, checking, neutralizing, obsessing, ordering, and hoarding. A score of 21 or higher indicates likely OCD.
Depression Anxiety Stress Scales-21 (DASS-21): A set of three self-report scales assessing stress, depression, and anxiety over 21 items. This shortened version is widely used for research and clinical purposes and is easy to administer.
Patient Health Questionnaire-9 (PHQ-9): A nine-item scale for assessing depressive symptoms. Scores are categorized as: 1-4 (no/minimal), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), and 20-27 (severe depression).
Generalized Anxiety Disorder-7 (GAD-7): A seven-item tool measuring anxiety symptoms and the severity of generalized anxiety disorder (GAD).
| Study group | Role | What they receive |
|---|---|---|
| chron's disease patients | patients diagnosed with CD at the department of Gastroenterology were collected from hospital records, and all patients were contacted and accepted to be part of this study Receives: Other: no intervention, questionnaires were used | |
| Healthy controls | Healthy Controls with no medical illness or mental illness before were invited to fill in the same questionnaire, the controls were relatives of patients attending the hospital for clinics not related to the gastrointestinal tract or psychiatry Receives: Other: no intervention, questionnaires were used |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study aims to determine the prevalence of obsessive-compulsive disorder in patients with CD and compare it with people without CD (controls)
The Depression Anxiety Stress Scales-21 (DASS-21)
Measured: 6 months
Secondary outcomes (2)
This study aims to determine the Patient Health Questionnaire-9 (PHQ-9) in patients with CD and compare it with people without CD (controls)
The Patient Health Questionnaire-9 (PHQ-9)
Measured: 6 months
This study aims to determine the Generalized Anxiety Disorder-7 (GAD-7) in patients with CD and compare it with people without CD (controls)
The Generalized Anxiety Disorder-7 (GAD-7)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start1 Sep 2022
- Primary completion1 Mar 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Sami El Muhtaseb, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429488
- Sponsor's protocol ID
- 233/2022
- Status last verified
- May 2024
- First submitted
- 17 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obsessive-compulsive Disorder, Depression and Anxiety Among Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT06429488
- Acronym / sponsor ID
- 233/2022
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Crohn's disease (CD) and obsessive-compulsive disorder (OCD) are two distinct medical conditions that affect millions of people worldwide. While numerous studies have explored anxiety and depression in CD, there is a notable lack of research about the link between OCD and CD. The aim of the study is to look for a relation between these seemingly unrelated conditions.
Methods: Patients with a diagnosis of Crohn's disease were given four different questionnaires in order to assess for the presence of obsessive-compulsive disorder, depression, and anxiety symptoms using the OCI-R score, DASS-21, PHQ-9, and GAD-7. The same questionnaires were used to assess healthy controls for similar symptoms.
Detailed description
This is an observational case-control study conducted at Jordan University Hospital. Using hospital medical records, patients with Crohn's disease who had been treated and followed up at the gastro-enterology and colorectal clinics were contacted to obtain consent to participate in the research and to explain its goals and the nature of the questionnaires used. Patients who agreed to participate were sent an online questionnaire to fill in. Healthy Controls with no medical illness or mental illness were invited to fill in the same questionnaire. The controls were relatives of patients attending the hospital for clinics not related to the gastrointestinal tract or psychiatry. Patients and controls with documented psychiatric illnesses were excluded.
The following psychological assessment tools were used:
The Obsessive-Compulsive Inventory-Revised (OCI-R) for obsessive-compulsive symptoms. It is composed of an 18-item self-report validated questionnaire that measures symptoms across 6 subscales including washing, checking, neutralizing, obsessing, ordering, and hoarding. The possible range of scores is 0-72.
The Depression Anxiety Stress Scales-21 (DASS-21) for overall emotional well-being. It is a set of three self-report scales to understand the degree of stress and distress, depressive and anxiety symptoms. The shortened version was used, which consists of 21 items and has been widely used for research and clinical purposes and is easy to administer.
The Patient Health Questionnaire-9 (PHQ-9), a nine-item depression scale of the patient health questionnaire, to assess depressive symptoms. The individual responses are interpreted as a score, with depression divided from no depression to severe depression.
The Generalized Anxiety Disorder-7 (GAD-7), a seven-item tool used to measure or assess anxiety symptoms and the severity of generalized anxiety disorder (GAD).
Data analysis:
The data was collected using Microsoft Forms and downloaded into Excel for coding and deidentification before being imported into the Statistical Package for Social Science (IBM SPSS Statistics for Windows, version 25, IBM Corp., Armonk, N.Y., USA) for analysis. The chi-square test was used to compare different categorical variables. The Mann-Whitney U test was used to compare non-categorical variables. The Kruskal-Wallis test was applied to test for significant differences between the scales.
Ethical consideration:
This study adhered to the principles of the Declaration of Helsinki 1975 and was approved by the Institutional Review Board at Jordan University Hospital.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chron's disease patients | – | Other: no intervention, questionnaires were usedpatients diagnosed with CD at the department of Gastroenterology were collected from hospital records, and all patients were contacted and accepted to be part of this study |
| Healthy controls | – | Other: no intervention, questionnaires were usedHealthy Controls with no medical illness or mental illness before were invited to fill in the same questionnaire, the controls were relatives of patients attending the hospital for clinics not related to the gastrointestinal tract or psychiatry |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This is an observational case-control study was conducted at Jordan University Hospital, Using hospital medical records, patients with Crohn's disease who been treated and followed up at the gastro-enterology and colorectal clinics were contacted to obtain their consent to participate in the research and to explain its goals and the nature of the questionnaires used. Patients who agreed to participate were sent an online questionnaire to fill in. Healthy Controls with no medical illness or mental illness before were invited to fill in the same questionnaire, the controls where relatives of patients attending the hospital for clinics not related to the gastrointestinal tract or psychiatry. Patients and controls with documented psychiatric illnesses were excluded.
Key inclusion criteria (5 listed)
- Patients diagnosed with Crohn's disease who have been treated and followed up at the gastro-enterology and colorectal clinics of Jordan University Hospital.
- Patients who have provided informed consent to participate in the research after being informed about the study's goals and the nature of the questionnaires used.
- Healthy controls with no prior history of medical or mental illness.
- Controls who are relatives of patients attending non-gastroenterology and non-psychiatry clinics at Jordan University Hospital.
- Participants (both patients and healthy controls) who agree to fill in the online questionnaire.
Key exclusion criteria (1 listed)
- Patients and controls with documented psychiatric illnesses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention, questionnaires were usedThe following psychological assessment tools were used: Obsessive-Compulsive Inventory-Revised (OCI-R): An 18-item self-report questionnaire measuring symptoms across six subscales: washing, checking, neutralizing, obsessing, ordering, and hoarding. A score of 21 or higher indicates likely OCD. Depression Anxiety Stress Scales-21 (DASS-21): A set of three self-report scales assessing stress, depression, and anxiety over 21 items. This shortened version is widely used for research and clinical purposes and is easy to administer. Patient Health Questionnaire-9 (PHQ-9): A nine-item scale for assessing depressive symptoms. Scores are categorized as: 1-4 (no/minimal), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), and 20-27 (severe depression). Generalized Anxiety Disorder-7 (GAD-7): A seven-item tool measuring anxiety symptoms and the severity of generalized anxiety disorder (GAD). | Other | Healthy controls, chron's disease patients |
Primary outcome
This study aims to determine the prevalence of obsessive-compulsive disorder in patients with CD and compare it with people without CD (controls)
Time frame: 6 months
The Depression Anxiety Stress Scales-21 (DASS-21)
2 secondary outcomes
This study aims to determine the Patient Health Questionnaire-9 (PHQ-9) in patients with CD and compare it with people without CD (controls)
Time frame: 6 months
This study aims to determine the Generalized Anxiety Disorder-7 (GAD-7) in patients with CD and compare it with people without CD (controls)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
This study aims to determine the prevalence of obsessive-compulsive disorder in patients with CD and compare it with people without CD (controls) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.