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Understanding and Treating Neuropsychiatric Symptoms of Pediatric Physical Illness

Understanding and Treating Neuropsychiatric Symptoms of Pediatric Physical Illness

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00769353
Enrollment
90
Registered
2008-10-09
Start date
2008-01-31
Completion date
2014-01-31
Last updated
2014-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALPrimary and Secondary Coping Enhancement Training

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

BEHAVIORALSupportive 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

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Neurological MeasuresBaselineCompare 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

MeasureTime frameDescription
Change in baseline CDI score to three monthsmonth 0, month 3Change in Childhood Depression Inventory (CDI) score from month 0 assessment to three month assessment.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026