Obsessive-compulsive Disorder, Depression and Anxiety Among Patients With Crohn's Disease

May 29, 2024 updated by: Mohammad Sami El Muhtaseb, University of Jordan

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

Completed

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

Observational

Enrollment (Actual)

293

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Amman, Jordan, 11942
        • the Jordan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

May 17, 2024

First Submitted That Met QC Criteria

May 23, 2024

First Posted (Actual)

May 28, 2024

Study Record Updates

Last Update Posted (Actual)

May 31, 2024

Last Update Submitted That Met QC Criteria

May 29, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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