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Sleep, Mood, and Behavior Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00787397
Enrollment
51
Registered
2008-11-07
Start date
2009-02-28
Completion date
2013-12-31
Last updated
2016-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Anxiety Disorder, Separation Anxiety Disorder, Sleep Difficulties in Pediatric 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

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.

Interventions

BEHAVIORALCognitive Behavioral Therapy-Sleep

Cognitive Behavioral Therapy: 6 sessions of CBT

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Years to 14 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026