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Sleep, Mood, and Behavior Study

Primary Purpose

Sleep Difficulties in Pediatric Anxiety Disorder, Generalized Anxiety Disorder, Separation Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy-Sleep
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Difficulties in Pediatric Anxiety Disorder focused on measuring 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

Eligibility Criteria

9 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1. Cognitive Behavioral Therapy-Sleep

Arm Description

Cognitive Behavioral Therapy-Sleep

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
November 5, 2008
Last Updated
January 6, 2016
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00787397
Brief Title
Sleep, Mood, and Behavior Study
Official Title
Sleep, Mood, and Behavior Study:Transdisciplinary Studies of CBT for Anxiety in Youth
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. Cognitive Behavioral Therapy-Sleep
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy-Sleep
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy-Sleep
Intervention Description
Cognitive Behavioral Therapy: 6 sessions of CBT
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal D Ryan, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

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Sleep, Mood, and Behavior Study

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