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Understanding and Treating Neuropsychiatric Symptoms of Pediatric Physical Illness

Primary Purpose

Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Primary and Secondary Coping Enhancement Training
Supportive Non-directive Therapy
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammatory Bowel Disease

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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:

  1. 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.
  2. 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:

  1. CDI or CDI-P > 10 at Step 1
  2. Childhood Depression Rating Scale-revised (CDRS-R) > 34 at Step 2
  3. 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

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Behavioral Therapy-PASCET

Supportive Non-Directive Therapy (SNDT)

Arm Description

Primary and Secondary Coping Enhancement Training (PASCET)

Supportive Non-Directive Therapy (SNDT)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in baseline CDI score to three months
Change in Childhood Depression Inventory (CDI) score from month 0 assessment to three month assessment.

Full Information

First Posted
March 24, 2008
Last Updated
May 20, 2014
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT00769353
Brief Title
Understanding and Treating Neuropsychiatric Symptoms of Pediatric Physical Illness
Official Title
Understanding and Treating Neuropsychiatric Symptoms of Pediatric Physical Illness
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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 neurobiological basis of depression in chronic pediatric physical illness using inflammatory bowel disease (IBD) as a model. It also evaluates the efficacy of a modified cognitive behavioral therapy (CBT) on emotional well-being, physical health, economic costs, and neurobiological outcomes. These results will provide key building blocks for a paradigm shift within medicine by integrating behavioral health into the comprehensive medical care of physical illnesses. Little is known about how the brain and body interact to increase depressive vulnerability, particularly in youth. Adult studies identify disruptions in limbic and prefrontal brain activity in the pathophysiology of depression. Cytokines secondary to inflammation and exogenous treatment with steroids can cause mood and cognitive changes in these same brain regions. It is important to understand the neuropsychiatric effects of IBD and its treatment on underlying brain structures during adolescence, a critical developmental period for brain maturation underlying emotional regulation and cognitive processing. More importantly, neuronal plasticity during adolescence may still allow reversibility of disease-related brain effects through teaching coping strategies for life-long illness management that could change developmental trajectories and reduce vulnerability in adulthood. Using translational neuroscience approaches, this research will examine: 1) brain regions that underlie emotional and cognitive processing in youth with active IBD and depression using brain functional magnetic resonance imaging compared to youth with IBD and no depression, and normal controls; 2) the inter-relationship between depressive symptoms in IBD and brain, immune, and gastrointestinal functioning; and 3) efficacy of a combined CBT-physical illness narrative intervention targeting emotional and cognitive processing compared to supportive non-directive therapy in the depressed IBD cohort with longitudinal tracking of emotional, physical health, economic, and neurobiological outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease, Depression

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy-PASCET
Arm Type
Experimental
Arm Description
Primary and Secondary Coping Enhancement Training (PASCET)
Arm Title
Supportive Non-Directive Therapy (SNDT)
Arm Type
Active Comparator
Arm Description
Supportive Non-Directive Therapy (SNDT)
Intervention Type
Behavioral
Intervention Name(s)
Primary and Secondary Coping Enhancement Training
Intervention Description
A cognitive behavioral therapy designed to help individuals cope with physical illness.
Intervention Type
Behavioral
Intervention Name(s)
Supportive Non-directive Therapy
Intervention Description
A non-structured therapy designed to provide a supportive atmosphere in which individuals may discuss concerns and process events in their lives
Primary Outcome Measure Information:
Title
Neurological Measures
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Change in baseline CDI score to three months
Description
Change in Childhood Depression Inventory (CDI) score from month 0 assessment to three month assessment.
Time Frame
month 0, month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva M Szigethy, MD, Ph.D.
Organizational Affiliation
University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

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