Sleep, Mood, and Behavior Study

Study Overview
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Brief Summary
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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
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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 processes involved in the treatment response of anxiety disorders in youth. This protocol will offer a six to eight session sleep intervention (Sleeping Tigers)children ages 9-13 who currently have a DSM-IV anxiety disorder and who endorse some level of impairment in their ability to sleep. Participants will have completed a 16 session intervention for anxiety (IRB submission, Child Anxiety Treatment Study CATS). We hope to assess whether improving sleep will further enhance affective, clinical, and social functioning.

Official Title
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Sleep, Mood, and Behavior Study:Transdisciplinary Studies of CBT for Anxiety in Youth

Conditions
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Sleep Difficulties in Pediatric Anxiety Disorder, Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy-Sleep


Participation Criteria
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Eligibility 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) 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. Cognitive Behavioral Therapy-Sleep<br>Cognitive Behavioral Therapy-Sleep | Behavioral: Cognitive Behavioral Therapy-Sleep<br>* Cognitive Behavioral Therapy: 6 sessions of CBT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of sleep therapy effects on anxiety symptoms are established by assessments of clinical status, symptoms, affective style, sleep,parent-child interactions using rating scales, self-report measures, and behavioral observations. |  | 6 to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep difficulties in pediatric anxiety disorder, Neural correlates of pediatric anxiety disorder, Social correlates of pediatric anxiety disorder, Generalized Anxiety Disorder in pediatric populations, Separation Anxiety Disorder in pediatric populations, Social Phobia in pediatric populations