Status:
COMPLETED
Understanding and Treating Neuropsychiatric Symptoms of Pediatric Physical Illness
Lead Sponsor:
University of Pittsburgh
Conditions:
Inflammatory Bowel Disease
Ulcerative Colitis
Eligibility:
All Genders
12-17 years
Phase:
NA
Brief Summary
This research will examine the impact of brain activity, cognitive processing immune functioning, and gastrointestinal functioning on depressive symptoms and response to a psychotherapeutic interventi...
Detailed Description
Depression is costly, worsens morbidity and mortality, and has detrimental effects on disease course in physically ill populations. This research takes a novel multi-dimensional approach to assess the...
Eligibility Criteria
Inclusion
- Inclusion criteria for youths with IBD for Step 1 of Screening Process:
- Age 12 to 17 inclusive
- English-speaking
- Capable of completing CDI
- Meeting diagnostic criteria for IBD
- Absence of mental retardation by history
- Having at least one appointment at the GI clinic.
- Criteria for Classification of IBD:
- Presence of appropriate history: abdominal pain, chronic diarrhea, bloody diarrhea (with or without extraintestinal symptoms) or, less commonly, a) primary extraintestinal symptoms, b) growth retardation, c) perirectal abscess, or d) acute abdomen.
- Evidence of colitis, ileitis or granulomatous esophagitis, gastritis or duodenitis by biopsy and/or small bowel strictures or fistulas by X-ray or multiple small intestinal ulcerations by capsule endoscopy.
- Eligibility Criteria For youths with IBD for Intervention Phase of the Comparison Study
- 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
- 1\. 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
- Age 12 to 17 inclusive
- English-speaking
- Capable of completing CDI
- Absence of mental retardation by history
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00769353
Start Date
January 1 2008
End Date
January 1 2014
Last Update
May 21 2014
Active Locations (1)
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1
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213