Inflammatory Bowel Disease 11 Clinical Trial
Official title:
Steroid-induced Mood Changes in Patients With Inflammatory Bowel Disease
Steroid is commonly used to treat autoimmune disorders such as rheumatoid arthritis, lupus, and inflammatory bowel disease (Crohn's Disease and Ulcerative Colitis). However, its use is associated with numerous systemic side-effects, including diabetes, osteoporosis, and potentially significant mood changes. The investigators wish to determine how common patients with inflammatory bowel disease experience mood changes when they take steroid for their disease.
Patients who are eligible to participate in the study are invited. Before starting
prednisone therapy, the following data are collected: basic demographic data (age, gender),
education history, past medical history (particularly IBD history such as age of diagnosis
and previous treatments/surgery), current medications/non-prescription drugs will be
collected. IBD activity is measured by Harvey-Bradshaw Index for Crohn's Disease and Simple
Clinical Colitis Activity Index (SCCAI) for all subjects with Ulcerative Colitis. Subjects
are asked to complete self-administered surveys --- Internal State Scale (ISS) for patients
to self-report mood states including depressive, manic, or mixed states and Beck Depression
Inventory II (BDI-II) for screening depression
Two weeks after starting Prednisone 40 mg/day and at the end of steroid taper, IBD activity
will be measured by Harvey-Bradshaw Index for Crohn's Disease and Simple Clinical Colitis
Activity Index (SCCAI) for all subjects with Ulcerative Colitis. Self-administered surveys
--- Internal State Scale (ISS) and Beck Depression Inventory II (BDI-II) are completed.
It is possible that a new diagnosis of an underlying psychiatric disorder may be discovered
as a result of participating in this study. In the event that an underlying psychiatric
disorder is suspected based on the results of the questionnaires on the first visit (BDI-II
≥21 moderate depression or ISS Activation scale ≥ 155), the patient would be offered the
option for an expedited formal psychiatric referral. This will not exclude them from the
study unless therapy is deemed necessary by the consulting psychiatrist.
Should patients develop significant mood changes impairing daily/social functioning during
the study as a result of steroid therapy, they will be assessed urgently by attending
gastroenterologist and if necessary, in consultation with a psychiatrist to determine the
best course of action, which may include cessation of steroid therapy or addition of
psychiatric therapy. Otherwise, less significant mood changes will be monitored closely as
these may be expected to resolve upon discontinuation of steroid therapy.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label