Status:
COMPLETED
Sleep, Mood, and Behavior Study
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Sleep Difficulties in Pediatric Anxiety Disorder
Generalized Anxiety Disorder
Eligibility:
All Genders
9-14 years
Phase:
NA
Brief Summary
The purpose of this study is to assess whether improving sleep in children and adolescents with anxiety disorder will further enhance affective, clinical, and social functioning.
Detailed Description
This study is one of two interlinking protocols developed to investigate neural, affective, behavioral and social predictors of improvement as a critical next step in advancing the understanding of pr...
Eligibility Criteria
Inclusion
- Clinical diagnosis of DSM-IV diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), and Social Phobia (SP)
- Previous enrollment Cognitive Behavioral Therapy arm in ClinicalTrials.gov Identifier: NCT00774150 study, entitled, " Transdisciplinary Studies of CBT for Anxiety in Youth: Child Anxiety Treatment Study (CATS)"
- The child/adolescent must have a "sleep problem" defined as: difficulties at least 3 times within a 2-week period in one or more of the following domains:
- difficulties going to sleep
- difficulties waking during the night
- difficulties getting up on time for school because of tiredness/sleepiness
- daytime tiredness and/or irritability that the child or parent attributed to insufficient sleep
- erratic sleep-wake schedules
Exclusion
- IQ below 70 as assessed by the Wechsler Abbreviated Scale of Intelligence (WASI).
- Requires current ongoing treatment with psychoactive medications including anxiolytics and antidepressants.
- Acutely suicidal or at risk for harm to self or others.
- Any motor impairments or eye-hand coordination problems
- Sleep disorder or parasomnia.
- Taking any medication that might interfere with sleep.
- Has a medical problem that might interfere with sleep.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00787397
Start Date
February 1 2009
End Date
December 1 2013
Last Update
January 8 2016
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213