Dimensional Brain Behavior Predictors of CBT Outcomes in Pediatric Anxiety
Condition: Anxiety Disorders; Social Anxiety Disorder; Social Phobia; Generalized Anxiety Disorder; Separation Anxiety Disorder; Specific Phobia; Phobia; Agoraphobia; Panic Disorder; Panic Attack; Anxiety
MeSH terms: Anxiety Disorders; Phobic Disorders; Panic Disorder; Phobia, Social; Agoraphobia; Anxiety, Separation
Study type: Interventional

Summary: 
      Anxiety is among the most prevalent, costly and disabling illnesses and tends emerge early in
      childhood. Cognitive behavioral therapy (CBT) is the first-line treatment for early life
      anxiety, but as many as 40% of young patients who receive CBT fail to get better. The
      proposed study will examine brain changes marking positive response to CBT for anxiety and
      how these changes may differ in children compared adolescents. By helping us to understand
      how CBT works, this study will pave the way for new treatments to stop anxiety early.
    

Detailed description: 
      Impairing anxiety affects 33% of the population by adolescence and can become chronic,
      leading to depression, substance abuse, school-drop out and even suicide. To reduce anxiety
      and prevent its sequelae, patients must be effectively treated early; yet, the first line
      intervention, cognitive behavioral therapy (CBT), has a heterogeneous response with 40-60% of
      treated patients continuing to experience impairment from residual symptoms. The reasons for
      variability in CBT outcomes remain poorly understood, but individual (including
      developmental) differences in brain-behavioral targets of CBT may contribute. This proposal
      addresses two primary questions: 1) Do individual differences in CBT-relevant
      brain-behavioral functions lead to variation in CBT outcomes? and 2) Does development
      contribute to this variation? To answer these questions, this study will measure changes in
      brain and behavior markers of anxiety, before and after CBT, in children and adolescents
      across traditional, categorical anxiety disorders (e.g., social, generalized and separation
      anxiety disorders). Given that CBT facilitates control over fear to enable effective
      regulation, the investigators hypothesize that brain-behavioral markers of fear sensitivity,
      cognitive regulatory capacity and cognitive regulation of fear will predict and characterize
      mechanisms of CBT effect. In addition, the investigators hypothesize that these markers will
      differentially relate to CBT effect, depending on patient age.

      Children and adolescents (7.0 - 17.99 years) with clinically impairing anxiety will be
      randomized to receive CBT or a relaxation control therapy for 12 weeks. Before and after
      therapy, all participants will receive an MRI scan to see what regions of the brain become
      active when emotion and concentration tasks are performed and how that activation is changed
      after CBT.

      While the study itself is of parallel design for its data-collection and measurement purpose,
      it is listed as a partial-crossover design in the IRB-approved protocol because subjects
      randomized to the relaxation therapy are given the option of receiving 12-weeks of CBT
      sessions after the relaxation therapy data has been collected. Some limited data will be
      collected in patients who are initially randomized to relaxation therapy but then opt to
      crossover to CBT. MRI data will also be collected in healthy youth before and after 12 weeks
      (but without intervening therapy) to allow the investigators to control for the simple
      effects of time that may cause brain changes that are not related to therapy.
    

Intervention name(s): Cognitive Behavioral Therapy; Relaxation Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A therapy which teaches patients coping skills to manage anxiety and gradually yet repeatedly exposes patients to anxiety-provoking thoughts and situations until the anxiety habituates/diminishes.; An active control therapy with minimal effects on anxiety symptoms. If randomized to this therapy, participants will have the option to cross-over to CBT once the relaxation therapy arms has been completed.
Other intervention name(s): CBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anxiety; social anxiety disorder; generalized anxiety disorder; phobias; fears; worry