Actively Recruiting

Phase 2
Age: 8Years - 17Years
All Genders
NCT06595953

Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety

Led by National Institute of Mental Health (NIMH) · Updated on 2026-05-05

150

Participants Needed

1

Research Sites

251 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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....

CONDITIONS

Official Title

Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety

Who Can Participate

Age: 8Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability of subject and parent to understand the study and willingness to assent/consent
  • Male or female aged 8 to 17 years
  • Clinician confirmed diagnosis of separation anxiety disorder, generalized anxiety disorder, or social anxiety disorder
  • Willingness to attend 12 weekly in-person CBT sessions
  • Enrolled in Protocol 01-M-0192
  • Ability to speak, read, and write English
  • IQ above 70 as assessed by WASI or clinical staff under Protocol 01-M-0192
Not Eligible

You will not qualify if you...

  • Current use of any psychotropic medication
  • Participation in another treatment or intervention study
  • Ongoing mental health treatment outside of NIH
  • Any mental health diagnosis other than an anxiety disorder
  • Any serious medical conditions
  • Restrictions preventing in-person attendance of therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

Loading map...

Research Team

D

Daniel S Pine, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here