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Sleep, Mood, and Behavior Study

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Neal Ryan, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00787397
First received: November 5, 2008
Last updated: October 12, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Sleep Difficulties in Pediatric Anxiety Disorder
Generalized Anxiety Disorder
Separation Anxiety Disorder
Social Phobia
 Behavioral: Cognitive Behavioral Therapy-Sleep

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sleep, Mood, and Behavior Study:Transdisciplinary Studies of CBT for Anxiety in Youth

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Phobias
U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2009
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. Cognitive Behavioral Therapy-Sleep
Cognitive Behavioral Therapy-Sleep
 Behavioral: Cognitive Behavioral Therapy-Sleep
Cognitive Behavioral Therapy: 6 sessions of CBT

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

Ages Eligible for Study:   9 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787397

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Neal D Ryan, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Neal Ryan, Joaquim Puig-Antich Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00787397     History of Changes
Other Study ID Numbers: PRO08010426, P50 MH080215-01A1
Study First Received: November 5, 2008
Last Updated: October 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
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

Additional relevant MeSH terms:
Anxiety Disorders
Anxiety, Separation
Mental Disorders
Phobic Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on June 17, 2013