Trial record 7 of 2262 for:    ANXIETY

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Neal Ryan, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00774150
First received: October 16, 2008
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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 Intervention
Generalized Anxiety Disorder
Separation Anxiety Disorder
Social Phobia
Behavioral: Cognitive Behavioral Therapy
Behavioral: Client Centered Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transdisciplinary Studies of CBT for Anxiety in Youth

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive and affective information processing will be measured using fMRI, pupil dilation/eye tracking, and event-related potential (ERP) assessment. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 194
Study Start Date: October 2008
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   9 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774150

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Neal D Ryan, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Neal Ryan, Joaquim Puig-Antich Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00774150     History of Changes
Other Study ID Numbers: PRO07110273, P50 MH080215-01A1
Study First Received: October 16, 2008
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Anxiety, Separation
Mental Disorders
Phobic Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on August 28, 2014