Sleep, Mood, and Behavior Study

Generalized Anxiety Disorder Clinical Trial

Official title:

Sleep, Mood, and Behavior Study:Transdisciplinary Studies of CBT for Anxiety in Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00787397
• Other study ID #: PRO08010426
• Secondary ID: P50MH080215-01A1
• Status: Completed
• Phase: N/A
• First received: November 5, 2008
• Last updated: January 6, 2016
• Start date: February 2009
• Est. completion date: December 2013

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 14 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety, Separation
• Disease
• Generalized Anxiety Disorder
• Mental Disorders
• Separation Anxiety Disorder
• Sleep Difficulties in Pediatric Anxiety Disorder
• Social Phobia

Intervention

Behavioral:
• Cognitive Behavioral Therapy-Sleep
Cognitive Behavioral Therapy: 6 sessions of CBT

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No