Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age8-17
SponsorNational Institute of Mental Health (NIMH)

About this trial

Background:

Anxiety disorders are becoming more common among children and teenagers. Anxiety can lead to long-term physical and mental problems, such as depression. Treatments for anxiety disorders include medications as well as cognitive behavioral therapy (CBT); CBT is a form of talking therapy. Both approaches work in only about 50 percent of cases. A new approach, called gaze-contingent music reward therapy (GCMRT), may help.

Objective:

To find out whether GCMRT combined with CBT is more effective than CBT alone.

Eligibility:

Children aged 8 to 17 years with separation anxiety disorder; generalized anxiety disorder; or social anxiety disorder. They must be enrolled in protocol 01-M-0192.

Design:

Participants will come to the clinic once a week for 4 weeks for CBT. Sometimes the participant will meet with the doctor alone; sometimes their parent may be present. They will do some computer-based tasks: They may be asked to push a button when a target appears; they may look at pictures of faces while the computer tracks their eye movements. Participants will take questionnaires each week. They will answer questions about their anxiety symptoms, feelings, and behavior.

For the next 8 weeks, participants will participate in both CBT and 1 of 2 types of GCMRT.

GCMRT is a computer-based task. Participants will look at pictures with many faces in them; while they do this, pleasant music will play and stop playing over a 12-minute period.

Participants will have a final visit in week 13. They will take questionnaires. They will do final research tasks. Each visit lasts about 2 hours.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Gaze-Contingent Music Reward Therapy

Treatment groups

150 Participants
are divided into 2 treatment groups