ClinicalTrials.gg
CompletedNCT00787397Updated Jan 8, 2016

Sleep, Mood, and Behavior Study

An interventional study of Cognitive Behavioral Therapy-Sleep in Sleep Difficulties in Pediatric Anxiety Disorder, Generalized Anxiety Disorder and Separation Anxiety Disorder, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 9 Years to 14 Years. Per ClinicalTrials.gov, last updated 2016-01-08.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Not applicable
Ages
9 Years to 14 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Generalized Anxiety Disorder

517 studies on the registry are indexed under Generalized Anxiety Disorder; 124 are open to participants now.

This study's enrollment of 51 is below the median of 83 across 439 interventional studies indexed under Generalized Anxiety Disorder.

Browse Generalized Anxiety Disorder studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Clinical diagnosis of 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    1. Cognitive Behavioral Therapy-Sleep

    Cognitive Behavioral Therapy-Sleep

    Behavioral: Cognitive Behavioral Therapy-Sleep

Interventions

  • BehavioralCognitive Behavioral Therapy-Sleep

    Cognitive Behavioral Therapy: 6 sessions of CBT

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 to 8 weeks

07

Study locations

1 site
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15213, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00787397
Responsible party
Neal Ryan (Joaquim Puig-Antich Professor of Psychiatry, University of Pittsburgh) — Principal investigator
First posted
Nov 7, 2008
Start date
Feb 2009
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Jan 8, 2016

Study contacts

Neal D Ryan, MD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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