RecruitingPhase 2NCT06595953

Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety

Phase II Efficacy Study of Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety


Sponsor

National Institute of Mental Health (NIMH)

Enrollment

150 participants

Start Date

Dec 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 8 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding eye-tracking-based music therapy to standard cognitive behavioral therapy (CBT) can improve anxiety treatment outcomes for children and teens. It combines a proven talk therapy approach with a new interactive music tool. **You may be eligible if...** - You are between 8 and 17 years old - You have been diagnosed with separation anxiety, generalized anxiety, or social anxiety disorder - You are willing to attend 12 weekly in-person CBT sessions - You are already enrolled in NIH Protocol 01-M-0192 - You speak, read, and write English - Your IQ is above 70 **You may NOT be eligible if...** - You are currently taking any psychiatric medications - You are in another treatment study or receiving outside mental health care - You have a mental health diagnosis other than an anxiety disorder - You have serious medical conditions - You cannot attend in-person therapy sessions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALGaze-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.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT06595953


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