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Completed

NCT Number: NCT00787397

Sleep, Mood, and Behavior Study

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.

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Key information

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Behavioral Therapy-Sleep

Behavioral

Cognitive Behavioral Therapy: 6 sessions of CBT

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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Nov 7, 2008
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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