Sleep, Mood, and Behavior Study - Full Text View

Sponsors and Collaborators:	University of Pittsburgh National Institute of Mental Health (NIMH)
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00787397

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 Behavioral: Client Centered Therapy-Sleep

MedlinePlus related topics: Anxiety Phobias

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Sleep, Mood, and Behavior Study:Transdisciplinary Studies of CBT for Anxiety in Youth

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 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
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
1. Cognitive Behavioral Therapy-Sleep: Experimental Cognitive Behavioral Therapy-Sleep	Behavioral: Cognitive Behavioral Therapy-Sleep Cognitive Behavioral Therapy: 6 sessions of CBT
2 Client Centered Therapy: Active Comparator	Behavioral: Client Centered Therapy-Sleep Client Centered Therapy-Sleep: 6 sessions of CCT-Sleep

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 either a six-week sleep intervention (Sleeping Tigers) or a comparison supportive treatment (Child Centered Therapy (CCT-sleep) to 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 14 week 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 13 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

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:

Ronald E Dahl, MD

University of Pittsburgh

More Information

No publications provided

Responsible Party:	University of Pittsburgh ( Ronald E. Dahl, MD Professor of Psychiatry and Pediatrics )
Study ID Numbers:	PRO08010426, P50 MH080215-01A1
Study First Received:	November 5, 2008
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00787397 History of Changes
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

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Anxiety, Separation
Phobic Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders

Mental Disorders Diagnosed in Childhood
Anxiety, Separation
Phobic Disorders

ClinicalTrials.gov processed this record on May 07, 2009