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

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ClinicalTrials.gov Identifier: NCT00774150
Recruitment Status : Completed
First Posted : October 17, 2008
Last Update Posted : July 18, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Neal Ryan, University of Pittsburgh

October 16, 2008
October 17, 2008
July 18, 2014
October 2008
July 2014   (Final data collection date for primary outcome measure)
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 ]
Evidence of therapy effects on anxiety sypmtoms 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 ]
Complete list of historical versions of study NCT00774150 on ClinicalTrials.gov Archive Site
Cognitive and affective information processing will be measured using fMRI, pupil dilation/eye tracking, and event-related potential (ERP) assessment. [ Time Frame: 16 weeks ]
Same as current
Not Provided
Not Provided
 
Transdisciplinary Studies of CBT for Anxiety in Youth: Child Anxiety Treatment Study
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Generalized Anxiety Disorder
  • Separation Anxiety Disorder
  • Social Phobia
  • Behavioral: Cognitive Behavioral Therapy
    16 sessions of CBT
  • Behavioral: Client Centered Therapy
    16 sessions of CCT
  • Experimental: 1. Cognitive Behavioral Therapy
    Intervention: Behavioral: Cognitive Behavioral Therapy
  • Active Comparator: 2. Client Centered Therapy
    Intervention: Behavioral: Client Centered Therapy
Ladouceur CD, Tan PZ, Sharma V, Bylsma LM, Silk JS, Siegle GJ, Forbes EE, McMakin DL, Dahl RE, Kendall PC, Mannarino A, Ryan ND. Error-related brain activity in pediatric anxiety disorders remains elevated following individual therapy: a randomized clinical trial. J Child Psychol Psychiatry. 2018 Nov;59(11):1152-1161. doi: 10.1111/jcpp.12900. Epub 2018 Mar 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
194
200
July 2014
July 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
9 Years to 14 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00774150
PRO07110273
P50MH080215-01A1 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Neal Ryan, University of Pittsburgh
University of Pittsburgh
National Institute of Mental Health (NIMH)
Principal Investigator: Neal D Ryan, MD University of Pittsburgh
University of Pittsburgh
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP