- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06429488
Obsessive-compulsive Disorder, Depression and Anxiety Among Patients With Crohn's Disease
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Amman, Jordan, 11942
- the Jordan University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients and controls with documented psychiatric illnesses.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
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). |
|
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
|
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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
The Patient Health Questionnaire-9 (PHQ-9)
|
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
|
The Generalized Anxiety Disorder-7 (GAD-7)
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 233/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Inflammatory Bowel Diseases
-
Cook Children's Health Care SystemNot yet recruitingIBD | IBD - Inflammatory Bowel Disease | IBD (Inflammatory Bowel Disease)United States
-
Ningbo Medical Center Lihuili HospitalRecruitingInflammatory Bowel Disease (IBD)China
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruitingIBD - Inflammatory Bowel DiseaseItaly
-
Chang Kyun LeeChonnam National University Hospital; Kyungpook National University Hospital; Chung-Ang University Hosptial, Chung-Ang University College of Medicine and other collaboratorsRecruitingInflammatory Bowel Disease (IBD)Korea, Republic of
-
Xijing HospitalNot yet recruitingInflammatory Bowel Diseases (IBD)China
-
Assiut UniversityNot yet recruitingInflammatory Bowel Disease (IBD)
-
University of British ColumbiaCompletedInflammatory Bowel Disease 11Canada
-
University of ChicagoTerminatedInflammatory Bowel Disease (IBD)United States
-
University of Texas Southwestern Medical CenterEnrolling by invitationInflammatory Bowel Disease | Inflammatory Bowel Disease (IBD)United States
-
University Hospital, GrenobleInstitute for Advanced Biosciences (IAB), GrenobleNot yet recruitingInflammatory Bowel Disease (IBD)France
Clinical Trials on no intervention, questionnaires were used
-
Lanyue ZhuRecruitingKidney Injury, AcuteChina
-
FrieslandCampinaCompleted
-
Halic UniversityCompletedFunction | Hand | Piano TherapyTurkey (Türkiye)
-
University Hospital, BrestUnknownDuchenne Dystrophy MuscularFrance
-
Lawson Health Research InstituteCompletedUveitis | Macular Edema | Retinal Vein Occlusion | Retinitis | Orbital Diseases | Optic Neuritis | Keratoconjunctivitis Sicca | Conjunctivitis | Blindness | Xerophthalmia | Papilledema | Iridocyclitis | Retinal Artery Occlusion | Amaurosis Fugax | Scleritis | Eye Hemorrhage | Chorioretinitis | Choroid Hemorrhage
-
Royal Brompton & Harefield NHS Foundation TrustCompletedNeuromuscular Diseases | Neurologic DisorderUnited Kingdom
-
ProgenaBiomeCompletedCovid19 | SARS-CoV2 Infection | COVID-19 Pneumonia | SARS-CoV-2 Acute Respiratory Disease | COVID-19 Respiratory Infection | COVID-19 Acute Respiratory Distress Syndrome | COVID-19 Acute Bronchitis | COVID-19 Lower Respiratory InfectionUnited States
-
North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaCompletedObesity | Type2 DiabetesUnited States
-
Region SkaneLund UniversityRecruitingPersonality Disorders | Depression | Anhedonia | Suicide, Attempted | Psychiatric Diagnosis | CYP2D6 PolymorphismSweden