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Completed

NCT Number: NCT00774150

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

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

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Key information

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).
  • Requires current ongoing treatment with psychoactive medications including anxiolytics and antidepressants.
  • 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.
  • 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:

  • 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
  • Lifetime diagnosis of autism or Asperger syndrome, bipolar disorder, psychotic depression, schizophrenia, or schizoaffective disorder.

Specific exclusion criteria for controls includes:

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

16 sessions of CBT

Client Centered Therapy

Behavioral

16 sessions of CCT

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Transdisciplinary Studies of CBT for Anxiety in Youth

Acronym: CATS

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Oct 17, 2008
Registry last updated
Jul 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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