Understanding and Treating Neuropsychiatric Symptoms of Pediatric Physical Illness
Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease
About this trial
This is an interventional basic science trial for Inflammatory Bowel Disease
Eligibility Criteria
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
Inclusion Criteria:
- 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
Inclusion Criteria:
- Age 12 to 17 inclusive
- English-speaking
- Capable of completing CDI
- Absence of mental retardation by history
Exclusion Criteria:
- 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.
Sites / Locations
- Children's Hospital of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Cognitive Behavioral Therapy-PASCET
Supportive Non-Directive Therapy (SNDT)
Primary and Secondary Coping Enhancement Training (PASCET)
Supportive Non-Directive Therapy (SNDT)