Understanding and Treating Neuropsychiatric Symptoms of Pediatric Physical Illness

Completed · Not applicable

Conditions studied: Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease, Depression

In brief

This research will examine the impact of brain activity, cognitive processing immune functioning, and gastrointestinal functioning on depressive symptoms and response to a psychotherapeutic intervention in youths with Inflammatory Bowel Disease (IBD).

Key facts

Study ID

NCT00769353

Run by

University of Pittsburgh

People needed

90

Starts

2008-01-01

Expected to finish

2014-01-01

Last updated by the study team

2014-05-21

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• CDI or CDI-P > 10 at Step 1
• Childhood Depression Rating Scale-revised (CDRS-R) > 34 at Step 2
• Presence of at least one biological parent. Exclusion Criteria
• History or current episode of bipolar disorder, eating disorder, or psychotic disorder by Diagnostic and Statistical Manual (DSM)-IV criteria. 2. Recent suicide attempt (within 1 month of study entry) or depression severity requiring acute psychiatric hospitalization within 3 months of study entry. 3. Antidepressant medications within one month of assessment. 4. Substance abuse by history within 1 month of study entry. 5. Current treatment with CBT or failure of previous CBT trial for depression judged adequate by at least 12 treatment sessions over a period of less than 1 year conducted by an appropriately trained mental health provider using a manual. If currently receiving other psychotherapy modalities, willingness to suspend treatment for 12-week acute treatment phase of study.
• Physically Healthy Comparison Children
• Inclusion Criteria:
• Age 12 to 17 inclusive
• English-speaking
• Capable of completing CDI
• Absence of mental retardation by history

You may not qualify if…

• self-report of a cold, flu or other infection within the past two weeks
• self-reported use of any antibiotics within the past 2 weeks
• score of 6 or more on the blood draw screening questionnaire
• Screening process for youths with IBD: Participants will be recruited from the clinic through a 2-step screening of all consecutive pediatric patients seen in the IBD clinic or while medically hospitalized for an IBD flare-up at Children's Hospital of Pittsburgh, who have confirmed IBD and who meet the other eligibility criteria as determined by medical staff in IBD clinic (Tables 5 and 6). The medical diagnosis of IBD will be determined by a GI physician using criteria below and will be confirmed in the medical record. Step 1: administration of the CDI and CDI-P during the medical visit. Those subjects whose CDI and/or CDI-P score of > 10 will be invited by phone to participate in Step 2: a face to face interview. Step 2 assessment will be conducted within one week of Step 1 so that both CDI score and IBD severity ratings are still valid from the Step 1 screen.
• All subjects meeting eligibility criteria for Step 2 will be invited to participate in the completion of neuropsychiatric questionnaires, blood draw, pupil measurements, and brain functional magnetic resonance imaging.
• All subjects meeting eligibility criteria after Step 2 will be invited to participate in the treatment phase of the study.
• Normal controls (N=15) will be recruited from the Department of Pediatrics during outpatient clinical office visits.

Where it is running

• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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