Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety

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.

• INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• Ability of subject and parent to understand the study and the willingness to assent/consent into the study.
• Males and females; Age 8-17
• Clinician confirmed diagnosis of ongoing separation anxiety disorder, generalized anxiety disorder, or social anxiety disorder. A clinician will review a KSADS-PL DSM-5 (November 2016) (Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children) interview, which will have occurred on Protocol 01-M-0192, to confirm diagnosis
• Willingness to adhere to 12 weekly in-person sessions of CBT
• Enrolled in Protocol 01-M-0192
• Subjects must speak, read and write English to be able to participate
• All subjects will have IQ>70 as assessed by a WASI or assessment by trained clinical staff which will have occurred under Protocol 01-M-0192

Exclusion criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

• Current use of any psychotropic medication
• Ongoing participation in another treatment or intervention study
• Ongoing mental health treatment outside of NIH
• Any mental health diagnosis aside from an anxiety disorder as determined by the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
• Any serious medical conditions
• Restrictions that preclude in-person attendance of therapy