Dimensional Brain Behavior Predictors of CBT Outcomes in Pediatric Anxiety

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.

Conditions

• Anxiety Disorders
• Social Anxiety Disorder
• Social Phobia
• Generalized Anxiety Disorder
• Separation Anxiety Disorder
• Specific Phobia
• Phobia
• Agoraphobia
• Panic Disorder
• Panic Attack
• Anxiety

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy

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.

BEHAVIORAL

Relaxation Therapy

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.

Sponsors & Collaborators

• Ohio State University

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of Michigan

  lead OTHER

Principal Investigators

• Kate D. Fitzgerald, M.D. · University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-12-31

Primary Completion

2021-07-31

Completion

2021-11-12

Countries

• United States

Study Locations