Sleep, Mood, and Behavior Study

NCT00787397 | Completed DMC

• 2 other identifiers: PRO08010426P50MH080215-01A1
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

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.

  6 to 8 weeks

Study Arms (1)

1. Cognitive Behavioral Therapy-Sleep

EXPERIMENTAL

Cognitive Behavioral Therapy-Sleep

Behavioral: Cognitive Behavioral Therapy-Sleep

Interventions

Cognitive Behavioral Therapy-Sleep BEHAVIORAL

Cognitive Behavioral Therapy: 6 sessions of CBT

1. Cognitive Behavioral Therapy-Sleep

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety, Separation; Phobia, Social

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Neurodevelopmental Disorders; Phobic Disorders

Study Officials

• Neal D Ryan, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Joaquim Puig-Antich Professor of Psychiatry

Study Record Dates

• First Submitted: November 5, 2008
• First Posted: November 7, 2008
• Study Start: February 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 8, 2016

Record last verified: 2016-01

Locations

US (1)