| City: |
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Pittsburgh |
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State:
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PA |
| Zip Code: |
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15213 |
| Conditions: |
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Generalized Anxiety Disorder - Separation Anxiety Disorder - Social Phobia |
| Purpose: |
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The purpose of this study is to investigate neurobehavioral, affective, and social processes
that may influence and predict treatment response in pediatric anxiety disorders.
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| Study summary: |
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This protocol proposes to study neurobehavioral and social correlates of treatment response
in 200 youth (ages 9-13) with general anxiety disorder (GAD), separation anxiety disorder
(SAD), and social phobia (SP). All youth with an anxiety disorder will receive 14 weeks of
Cognitive Behavioral Therapy (CBT) or Client Centered Therapy (CCT) for child anxiety
disorders. The study combines state-of-the-art measures from affective neuroscience,
ecologically valid (EMA) measures of mood and behavior in natural environments, and measures
of family and social context within a developmentally framed treatment study. The study
design focuses on predictors and mechanisms of treatment response. This protocol will test
key features of a "vigilance-avoidance" model focusing on hypotheses that pretreatment
neural correlates of affective reactivity will predict treatment response and early changes
in emotional processing will correlate with clinical response during treatment. In addition,
the protocol examines how affective experiences within the family and social context are
associated with treatment response and change across treatment, and how these are associated
with and interact with neurobehavioral changes in affective functioning. Taken together
these aspects of the study will advance understanding of the neurobehavioral, affective, and
social processes that underpin treatment response in ways that will inform the design,
refinement, and optimal developmental timing of cognitive behavioral treatments, and thus,
decrease the morbidity, mortality, and lifetime impairments from these common disorders in
youth. |
| Criteria: |
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Inclusion Criteria:
- Clinical diagnosis of DSM-IV diagnosis of Generalized Anxiety Disorder (GAD),
Separation Anxiety Disorder (SAD), and Social Phobia (SP)
Exclusion Criteria:
- 1. IQ below 70 as assessed by the Wechsler Abbreviated Scale of Intelligence (WASI).
2. Requires current ongoing treatment with psychoactive medications including
anxiolytics and antidepressants.
3. Acutely suicidal or at risk for harm to self or others. 4. Any motor impairments
or eye-hand coordination problems 5. Persons not suited for fMRI procedures including
those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or
blood vessels, surgically implanted metal plates, screws or pins, cochlear implants,
IUDs, metal braces, or other metal objects in their body, especially in the eye.
Dental fillings do not present a problem. Plastic or removable dental appliances do
not require exclusion. Pregnancy, determined by pregnancy tests on post-menarcheal
females.
6. History of head injury. 7. Neuromuscular or neurological disorder 8. Vision that
is 20/40 and below that cannot be corrected by glasses or contacts.
Specific exclusion criteria for anxious participants includes:
1. Current comorbid diagnosis of: primary major depressive disorder (MDD) (subjects who
have primary GAD with co-morbid MDD that is secondary in terms of course and
functional impact are not excluded), obsessive-compulsive disorder (OCD),
post-traumatic stress disorder (PTSD), conduct disorder, substance abuse or
dependence
2. Lifetime diagnosis of autism or Asperger syndrome, bipolar disorder, psychotic
depression, schizophrenia, or schizoaffective disorder.
Specific exclusion criteria for controls includes:
1. Any current or lifetime DSM-IV diagnosis.
2. Having a parent with current or lifetime DSM-IV diagnosis of anxiety or mood
disorders. |
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| Study is available at: |
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University of Pittsburgh
Pittsburgh, PA 15213
United States
Primary Contact:
Sherri Karas, MA
Email: scheboths@upmc.edu
Phone: 412-383-8182 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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