Sleep, Mood, and Behavior Study | NCT00787397

Studies
Sleep, Mood, and Behavior Study

NCT00787397

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Jan 8, 2016Estimated

Enrollment

51Actual

Phase

Not Applicable

Conditions

Sleep Difficulties in Pediatric Anxiety Disorder
Generalized Anxiety Disorder
Separation Anxiety Disorder
Social Phobia

Interventions

Cognitive Behavioral Therapy-Sleep

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P50MH080215-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Nov 5, 2008

First Submission Date that Met QC Criteria

Nov 6, 2008

First Posted Date

Nov 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2016

Last Update Posted Date

Jan 8, 2016Estimated

Name	Class
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1. Cognitive Behavioral Therapy-Sleep	Experimental	Cognitive Behavioral Therapy-Sleep	Behavioral: Cognitive Behavioral Therapy-Sleep

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cognitive Behavioral Therapy-Sleep	Behavioral	Cognitive Behavioral Therapy: 6 sessions of CBT	1. Cognitive Behavioral Therapy-Sleep

Outcomes Module

Primary Outcomes

Measure	Description	Time 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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Neal D Ryan, MD	University of Pittsburgh	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Pittsburgh		Pittsburgh	Pennsylvania	15213	United States

Condition Browse Module

MeSH Terms

ID	Term
D000098647	Generalized Anxiety Disorder
D001010	Anxiety, Separation
D000072861	Phobia, Social

Ancestor Terms

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders
D065886	Neurodevelopmental Disorders
D010698	Phobic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided