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

Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety (NCT06595953) is a Phase 2 interventional studying Psychiatric Disorders and Anxiety Disorders, sponsored by National Institute of Mental Health (nimh). RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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....

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Psychiatric Disorders and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 150 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Psychiatric Disorders subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

* Who May Qualify: 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

* 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

Treatments Being Tested

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06595953), the sponsor (National Institute of Mental Health (nimh)), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06595953 clinical trial studying?

Who can participate in NCT06595953?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06595953?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06595953. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06595953. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.