Clinical trial NCT00787397: Sleep, Mood, and Behavior Study
Official title: Sleep, Mood, and Behavior Study:Transdisciplinary Studies of CBT for Anxiety in Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Difficulties in Pediatric Anxiety Disorder
Generalized Anxiety Disorder
Separation Anxiety Disorder
Social Phobia
Keywords: 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
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-11-07
Enrollment: 51
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of DSM-IV diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), and Social Phobia (SP)
2. 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)"
3. 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:

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. Sleep disorder or parasomnia.
6. Taking any medication that might interfere with sleep.
7. Has a medical problem that might interfere with sleep.

Primary outcomes:
measure: 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.
timeFrame: 6 to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Neal D Ryan, MD
role: PRINCIPAL_INVESTIGATOR
References: