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Understanding and Treating Neuropsychiatric Symptoms of Pediatric Physical Illness

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ClinicalTrials.gov Identifier: NCT00769353
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : May 21, 2014
Information provided by (Responsible Party):

March 24, 2008
October 9, 2008
May 21, 2014
January 2008
January 2014   (Final data collection date for primary outcome measure)
Neurological Measures [ Time Frame: Baseline ]
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.
Childhood Depression Rating System- Revised (CDRS-R) [ Time Frame: Baseline, 3 months, 9 months, 12 months ]
Complete list of historical versions of study NCT00769353 on ClinicalTrials.gov Archive Site
Change in baseline CDI score to three months [ Time Frame: month 0, month 3 ]
Change in Childhood Depression Inventory (CDI) score from month 0 assessment to three month assessment.
  • KVID- Subjects will be shown a series of words and asked to identify the valence of the words as positive, negative or neutral. [ Time Frame: baseline ]
  • CuedRT: This standard cognitive task will be used to obtain a baseline measure of cognitive activity. The mask of X's will be replaced by a string of a's. Youth are asked to hit a button as soon as a's appear on the screen. [ Time Frame: Baseline ]
  • Virtual Reality Navigation Task: Subjects will be asked to use a computer to navigate through a virtual reality city, looking for specific locations. [ Time Frame: Baseline ]
  • Functional Magnetic Resonance Imaging (fMRI) brain scan [ Time Frame: baseline ]
  • Measurements of Pupil Dilation (concurrent with fMRI scan) [ Time Frame: Baseline ]
  • Laboratory Measurement for inflammatory markers- blood draws will be utilized to measure erythrocyte sedimentation rate, C-reactive protein, hematocrit, and albumin, and saliva samples will be obtained to assess salivatory cortisol [ Time Frame: Baseline ]
  • Pediatric Crohn's Disease Activity Index (PCDAI) completed by the physician [ Time Frame: Basline, 3 months, 9 months, 12 months ]
  • Pediatric Ulcerative Colitis Activity Index (PUCAI) completed by physician [ Time Frame: Baseline, 3 months, 9 months, 12 months ]
  • Childhood Depressive Inventory (CDI) [ Time Frame: Baseline ]
  • Schedule for Affective Disorders and Schizophrenia- Kiddie version (KSADS) [ Time Frame: Baseline, 3 months, 9 months, 12 months ]
Not Provided
Not Provided
Understanding and Treating Neuropsychiatric Symptoms of Pediatric Physical Illness
Understanding and Treating Neuropsychiatric Symptoms of Pediatric Physical Illness
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).

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.

Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Inflammatory Bowel Disease
  • Ulcerative Colitis
  • Crohn's Disease
  • Depression
  • Behavioral: Primary and Secondary Coping Enhancement Training
    A cognitive behavioral therapy designed to help individuals cope with physical illness.
  • Behavioral: Supportive Non-directive Therapy
    A non-structured therapy designed to provide a supportive atmosphere in which individuals may discuss concerns and process events in their lives
  • Experimental: Cognitive Behavioral Therapy-PASCET
    Primary and Secondary Coping Enhancement Training (PASCET)
    Intervention: Behavioral: Primary and Secondary Coping Enhancement Training
  • Active Comparator: Supportive Non-Directive Therapy (SNDT)
    Supportive Non-Directive Therapy (SNDT)
    Intervention: Behavioral: Supportive Non-directive Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 2014
January 2014   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
12 Years to 17 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
DP2OD001210-01( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Eva Szigethy, University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Eva M Szigethy, MD, Ph.D. University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh
University of Pittsburgh
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP