A Phase 2 interventional study of Gaze-Contingent Music Reward Therapy in Psychiatric Disorders and Anxiety Disorders, sponsored by National Institute of Mental Health (NIMH). Recruiting at 1 site in United States. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by National Institute of Mental Health (NIMH) · Phase 2, Interventional, and Treatment
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.
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.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 150 is above the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →National Institute of Mental Health (NIMH) is the lead sponsor of 367 studies on the registry; 45 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 24 (96%) have results posted.
Compared within Anxiety Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Mental Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the active form of the therapy, music stops when subjects view negative valence faces.
Behavioral: Gaze-Contingent Music Reward Therapy
In the control condition, music plays continuously.
Behavioral: Gaze-Contingent Music Reward Therapy
All subjects will receive CBT and will be randomized to either active or control forms of GCMRT. This involves the monitoring of a patient s eye-movements during the free-viewing of computer-displayed matrices of faces expressing various emotions in tandem with the playing of pleasant music. In the active form of the therapy, music stops when subjects view negative valence faces, whereas in the control condition, music plays continuously. Subjects undergo 12 weeks of CBT, where GCMRT is delivered in the last eight weeks of therapy.
Pediatric Anxiety Rating Scale (PARS)
Completed by the clinician.
Time frame: Week 1-13.
Clinical Global Impression Scale (CGI)
Completed by the clinician.
Time frame: Week 1-13.
Screen for Child Anxiety Related Disorders (SCARED)
Completed by parents and patients.
Time frame: Week 1, 4, and 13.
Plan to share: No
Started Dec 2024 (actual). Primary completion is estimated for Oct 2029, 57 months after the start.
Of 81 non-industry phase 2 interventional studies under Anxiety Disorders, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 63. This study's planned 57 months is above that.
Counting every sponsor, half of 96 studies reached it within 35 months; a quarter within 18 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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