Active versus control Gaze-Contingent Music Reward Therapy (GCMRT) augmentation of cognitive behavioral therapy in the treatment of pediatric anxiety: protocol for a double-blind randomized controlled trial

Threat-related attention bias is an established correlate of anxiety disorders. Gaze-Contingent Music Reward Therapy (GCMRT), an eye-tracking based treatment, involves a music-based positive reinforcement training regimen of eye-gaze direction to reduce this bias. Recent studies have shown promise for GCMRT as an augmentative treatment to enhance the clinical impact of cognitive behavioral therapy (CBT). Yet, this augmentation approach has not been robustly tested among pediatric samples with anxiety disorders. This preregistered randomized controlled trial will compare the efficacy of randomly assigned active GCMRT vs. a control form of GCMRT among 120 patients (ages 8–17 years old) meeting DSM-5-TR criteria for an anxiety disorder, based on reduction in clinician-rated anxiety pre- to post-treatment between groups. Participants will receive active or control GCMRT alongside CBT. GCMRT involves a computer playing participant-selected music, which is linked to the patient’s eye-tracking patterns on matrices of negative and non-negative valence faces. Music plays continuously in the control group, while the active group only hears music while looking at non-negative faces. Behavioral and neural indices of change in attention bias will serve as primary measures of intervention effectiveness. Threat-related attention bias will be indexed as prolonged eye-gaze dwell time on negative-valence faces relative to non-negative faces, with change in this metric across treatment capturing shifts in attention bias. Youth will also complete functional magnetic resonance imaging (fMRI) before and after treatment while resting and during a dot-probe task with threatening face cues. Brain-based implicit threat response will be assessed via a neural efficiency approach. Healthy youth will serve as a baseline comparison to patients on brain-based threat response. Linear mixed effects models will examine between-group trajectories of behavioral attention bias, neural threat-response indices, and anxiety symptoms over the course of treatment. The present study will contribute to the literature by (1) determining whether GCMRT is an efficacious adjunct therapy to CBT for pediatric anxiety disorders, and (2) advancing our understanding of the neural mechanisms underlying GCMRT. Clinicaltrials.gov: NCT06595953. Trial registration date: September 19th, 2024. Data acquisition began December 4th, 2024.