Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06429488 |
| Other study ID # |
233/2022 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2022 |
| Est. completion date |
September 1, 2023 |
Study information
| Verified date |
May 2024 |
| Source |
University of Jordan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
