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

July 17, 2014 updated by: Neal Ryan, University of Pittsburgh

Transdisciplinary Studies of CBT for Anxiety in Youth

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

194

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 14 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
16 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

October 16, 2008

First Submitted That Met QC Criteria

October 16, 2008

First Posted (ESTIMATE)

October 17, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 18, 2014

Last Update Submitted That Met QC Criteria

July 17, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO07110273
  • P50MH080215-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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