Recruiting
Phase 2

Gaze-Contingent Music Therapy

Sponsor:

National Institute of Mental Health (NIMH)

Code:

NCT06595953

Conditions

Psychiatric Disorders

Anxiety Disorders

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

Interventions

Gaze-Contingent Music Reward Therapy

Study Details

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

Study ID

NCT06595953

Start date

Dec 4, 2024

Status verified date

Oct 1, 2026

Completion date

Oct 1, 2029

Anticipated

Primary completion date

Oct 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Ability of subject and parent to understand the study and the willingness to assent/consent into the study.
2. Males and females; Age 8-17
3. 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
4. Willingness to adhere to 12 weekly in-person sessions of CBT
5. Enrolled in Protocol 01-M-0192
6. Subjects must speak, read and write English to be able to participate
7. 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

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Current use of any psychotropic medication
2. Ongoing participation in another treatment or intervention study
3. Ongoing mental health treatment outside of NIH
4. Any mental health diagnosis aside from an anxiety disorder as determined by the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
5. Any serious medical conditions
6. Restrictions that preclude in-person attendance of therapy

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active-GCMRT

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

sham comparator: Sham-GCMRT

In the control condition, music plays continuously.

Interventions

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.

Primary outcome measure

  • Pediatric Anxiety Rating Scale (PARS) [ Time Frame: Week 1-13. ]

Central Contacts and Locations

Central contacts

Daniel S Pine, M.D.

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

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Mental Health (NIMH)

Last update posted

Oct 13, 2026

Last verified

Oct 1, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by National Institute of Mental Health (NIMH) on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.