Sleep, Mood, and Behavior Study

NCT ID: NCT00787397

Last Updated: 2016-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2013-12-31

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

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1. Cognitive Behavioral Therapy-Sleep

Cognitive Behavioral Therapy-Sleep

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy-Sleep

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy: 6 sessions of CBT

Interventions

Cognitive Behavioral Therapy-Sleep

Cognitive Behavioral Therapy: 6 sessions of CBT

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Neal Ryan

Joaquim Puig-Antich Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neal D Ryan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

P50MH080215-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO08010426

Identifier Type: -

Identifier Source: org_study_id