Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety

Description

Study Description:

This study compares the efficacy of Gaze-Contingent Music Reward Therapy (GCMRT) and a control form of GCMRT, both added to concurrent therapy. Efficacy will be examined for the severity of clinician-rated anxiety in medication-free children and adolescents with an anxiety disorder. For concurrent therapy, all patients will receive Cognitive Behavioral Therapy (CBT). With this design, efficacy is based on comparison of groups receiving CBT augmented with either active or control forms of GCMRT. A total of 150 patients will be enrolled in the study and will begin CBT therapy for three weeks. By the end of week three, participants will be randomly assigned in a one-to-one ratio to the two forms of GCMRT, which they will receive along with CBT for 9 weeks. From among the 150 patients who enroll in the study, 120 are expected to be randomized to one of the two forms of GCMRT.

Objectives:

Primary Objective: To test the efficacy of Gaze-Contingent Music Reward Therapy (GCMRT) for the augmentation of Cognitive Behavioral Therapy (CBT) treatment for pediatric anxiety disorders.

Secondary Objective: To test for efficacy on secondary outcome measures as well as to test for moderation and mediation of efficacy by measures of attention bias.

Endpoints:

Primary Endpoint: The severity of clinician-rated anxiety, blinded to the GCMRT condition, on the Pediatric Anxiety Rating Scale (PARS).

Secondary Endpoints: Overall treatment response on the clinician-rated Clinician Global Impression scale and rated symptoms of anxiety on the Screen for Child Anxiety Related Disorders (SCARED) scale, as completed by parents and patients.