Sleep, Mood, and Behavior Study

Not Applicable

Completed

• Conditions: Separation Anxiety Disorder; Sleep Difficulties in Pediatric Anxiety Disorder; Generalized Anxiety Disorder; Social Phobia
• Interventions: Behavioral: Cognitive Behavioral Therapy-Sleep

• Registration Number: NCT00787397
• Lead Sponsor: University of Pittsburgh

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2008-11-05
• Study First Submitted QC: 2008-11-06
• Study First Posted: 2008-11-07
• Study Start: 2009-02
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-06
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1. Cognitive Behavioral Therapy-Sleep	Cognitive Behavioral Therapy-Sleep	Cognitive Behavioral Therapy-Sleep

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States