Understanding and Treating Neuropsychiatric Symptoms of Pediatric Physical Illness

NCT00769353 | Completed DMC

• 1 other identifier: DP2OD001210-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 intervention in youths with Inflammatory Bowel Disease (IBD).

Conditions

Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease; Depression

Outcome Measures

Primary Outcomes (1)

• Neurological Measures

  Compare neurological measures (via brain scan, pupil dilation and laboratory blood values) in depressed individuals with IBD, non-depressed individuals with IBD and healthy controls.

  Baseline

Secondary Outcomes (1)

• Change in baseline CDI score to three months

  month 0, month 3

Study Arms (2)

Cognitive Behavioral Therapy-PASCET

EXPERIMENTAL

Primary and Secondary Coping Enhancement Training (PASCET)

Behavioral: Primary and Secondary Coping Enhancement Training

Supportive Non-Directive Therapy (SNDT)

ACTIVE COMPARATOR

Supportive Non-Directive Therapy (SNDT)

Behavioral: Supportive Non-directive Therapy

Interventions

Primary and Secondary Coping Enhancement Training BEHAVIORAL

A cognitive behavioral therapy designed to help individuals cope with physical illness.

Cognitive Behavioral Therapy-PASCET

Supportive Non-directive Therapy BEHAVIORAL

A non-structured therapy designed to provide a supportive atmosphere in which individuals may discuss concerns and process events in their lives

Supportive Non-Directive Therapy (SNDT)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \. 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
• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

  PMID: 40243391 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease; Depression

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Behavioral Symptoms; Behavior

Study Officials

• Eva M Szigethy, MD, Ph.D.

  University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry, Pediatrics, and Medicine

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: October 9, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: May 21, 2014

Record last verified: 2014-05

Locations

US (1)