Transdisciplinary Studies of CBT for Anxiety in Youth: Child Anxiety Treatment Study (CATS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00774150
Recruitment Status : Completed
First Posted : October 17, 2008
Last Update Posted : July 18, 2014
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Neal Ryan, University of Pittsburgh

Brief Summary:
The purpose of this study is to investigate neurobehavioral, affective, and social processes that may influence and predict treatment response in pediatric anxiety disorders.

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Separation Anxiety Disorder Social Phobia Behavioral: Cognitive Behavioral Therapy Behavioral: Client Centered Therapy Not Applicable

Detailed Description:
This protocol proposes to study neurobehavioral and social correlates of treatment response in 200 youth (ages 9-13) with general anxiety disorder (GAD), separation anxiety disorder (SAD), and social phobia (SP). All youth with an anxiety disorder will receive 14 weeks of Cognitive Behavioral Therapy (CBT) or Client Centered Therapy (CCT) for child anxiety disorders. The study combines state-of-the-art measures from affective neuroscience, ecologically valid (EMA) measures of mood and behavior in natural environments, and measures of family and social context within a developmentally framed treatment study. The study design focuses on predictors and mechanisms of treatment response. This protocol will test key features of a "vigilance-avoidance" model focusing on hypotheses that pretreatment neural correlates of affective reactivity will predict treatment response and early changes in emotional processing will correlate with clinical response during treatment. In addition, the protocol examines how affective experiences within the family and social context are associated with treatment response and change across treatment, and how these are associated with and interact with neurobehavioral changes in affective functioning. Taken together these aspects of the study will advance understanding of the neurobehavioral, affective, and social processes that underpin treatment response in ways that will inform the design, refinement, and optimal developmental timing of cognitive behavioral treatments, and thus, decrease the morbidity, mortality, and lifetime impairments from these common disorders in youth.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transdisciplinary Studies of CBT for Anxiety in Youth
Study Start Date : October 2008
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: 1. Cognitive Behavioral Therapy Behavioral: Cognitive Behavioral Therapy
16 sessions of CBT

Active Comparator: 2. Client Centered Therapy Behavioral: Client Centered Therapy
16 sessions of CCT

Primary Outcome Measures :
  1. Evidence of 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: 16 weeks ]

Secondary Outcome Measures :
  1. Cognitive and affective information processing will be measured using fMRI, pupil dilation/eye tracking, and event-related potential (ERP) assessment. [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Clinical diagnosis of DSM-IV diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), and Social Phobia (SP)

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. Persons not suited for fMRI procedures including those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or blood vessels, surgically implanted metal plates, screws or pins, cochlear implants, IUDs, metal braces, or other metal objects in their body, especially in the eye. Dental fillings do not present a problem. Plastic or removable dental appliances do not require exclusion. Pregnancy, determined by pregnancy tests on post-menarcheal females.

    6. History of head injury. 7. Neuromuscular or neurological disorder 8. Vision that is 20/40 and below that cannot be corrected by glasses or contacts.

Specific exclusion criteria for anxious participants includes:

  1. Current comorbid diagnosis of: primary major depressive disorder (MDD) (subjects who have primary GAD with co-morbid MDD that is secondary in terms of course and functional impact are not excluded), obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), conduct disorder, substance abuse or dependence
  2. Lifetime diagnosis of autism or Asperger syndrome, bipolar disorder, psychotic depression, schizophrenia, or schizoaffective disorder.

Specific exclusion criteria for controls includes:

  1. Any current or lifetime DSM-IV diagnosis.
  2. Having a parent with current or lifetime DSM-IV diagnosis of anxiety or mood disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00774150

United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute of Mental Health (NIMH)
Principal Investigator: Neal D Ryan, MD University of Pittsburgh

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Neal Ryan, Joaquim Puig-Antich Professor of Psychiatry, University of Pittsburgh Identifier: NCT00774150     History of Changes
Other Study ID Numbers: PRO07110273
P50MH080215-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 17, 2008    Key Record Dates
Last Update Posted: July 18, 2014
Last Verified: July 2014

Keywords provided by Neal Ryan, University of Pittsburgh:
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

Additional relevant MeSH terms:
Anxiety Disorders
Phobia, Social
Anxiety, Separation
Pathologic Processes
Mental Disorders
Phobic Disorders
Neurodevelopmental Disorders