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
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Disease Ulcerative Colitis Crohn's Disease Depression||Behavioral: Primary and Secondary Coping Enhancement Training Behavioral: Supportive Non-directive Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Understanding and Treating Neuropsychiatric Symptoms of Pediatric Physical Illness|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Experimental: Cognitive Behavioral Therapy-PASCET
Primary and Secondary Coping Enhancement Training (PASCET)
Behavioral: Primary and Secondary Coping Enhancement Training
A cognitive behavioral therapy designed to help individuals cope with physical illness.
Active Comparator: Supportive Non-Directive Therapy (SNDT)
Supportive Non-Directive Therapy (SNDT)
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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00769353
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Eva M Szigethy, MD, Ph.D.||University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh|