Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety

NCT06595953 | Recruiting Phase 2

• 2 other identifiers: 10001937001937-M
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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....

Conditions

Psychiatric Disorders; Anxiety Disorders

Keywords

Cognitive-behavioral therapy; Attention; Anxiety; Children; Adolescents

Outcome Measures

Primary Outcomes (1)

• Pediatric Anxiety Rating Scale (PARS)

  Completed by the clinician.

  Week 1-13.

Secondary Outcomes (2)

• Clinical Global Impression Scale (CGI)

  Week 1-13.

• Screen for Child Anxiety Related Disorders (SCARED)

  Week 1, 4, and 13.

Study Arms (2)

Active-GCMRT

ACTIVE COMPARATOR

In the active form of the therapy, music stops when subjects view negative valence faces.

Behavioral: Gaze-Contingent Music Reward Therapy

Sham-GCMRT

SHAM COMPARATOR

In the control condition, music plays continuously.

Behavioral: Gaze-Contingent Music Reward Therapy

Interventions

Gaze-Contingent Music Reward Therapy BEHAVIORAL

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.

Active-GCMRT; Sham-GCMRT

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Mental Disorders; Anxiety Disorders

Study Officials

• Daniel S Pine, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel S Pine, M.D.

CONTACT

(301) 594-1318; daniel.pine@nih.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: December 4, 2024
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: May 5, 2026

Record last verified: 2025-09-18

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)