Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety

NCT ID
NCT06595953
Registry status
Recruiting
Study type
Interventional
Phase
Phase 2
Sponsor
National Institute of Mental Health (NIMH)
Conditions
Anxiety Disorders, Psychiatric Disorders

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 150 participants (Estimated).

What is being studied

  • Behavioral: Gaze-Contingent Music Reward Therapy

Who may be eligible

Ages
8 Years to 17 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

* 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 locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • Maryland, United States: 1

Sample of listed locations

  • National Institutes of Health Clinical Center — Bethesda, Maryland, 20892, United States — Recruiting

Study details

Start date
December 4, 2024
Primary completion date
October 1, 2029
Completion date
October 1, 2029
First posted
September 19, 2024

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06595953
Registry last updated
October 2, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT06595953 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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