ClinConnect ClinConnect Logo
Search / Trial NCT06595953

Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety

Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Sep 18, 2024

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Cognitive Behavioral Therapy Attention Anxiety Children Adolescents

ClinConnect Summary

This clinical trial is studying a new approach to help children and teenagers who struggle with anxiety disorders, such as separation anxiety, generalized anxiety, or social anxiety. The researchers want to see if combining a traditional talking therapy called cognitive behavioral therapy (CBT) with a new method called gaze-contingent music reward therapy (GCMRT) can lead to better results than using CBT alone. GCMRT involves looking at pictures of faces while listening to pleasant music, and the way participants look at the pictures helps tailor the music experience.

To be eligible for this study, children aged 8 to 17 must have a confirmed anxiety disorder and be willing to attend weekly sessions for three months. Participants will take part in CBT sessions, complete computer tasks, and answer questions about their feelings and anxiety. The study is open to both boys and girls, and they should be comfortable speaking, reading, and writing in English. This trial offers a chance for young people to potentially improve their anxiety symptoms while being closely monitored and supported by healthcare professionals.

Gender

ALL

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

About National Institute Of Mental Health (Nimh)

The National Institute of Mental Health (NIMH) is a leading federal agency dedicated to advancing the understanding and treatment of mental health disorders through innovative research and clinical trials. As part of the National Institutes of Health (NIH), NIMH focuses on a broad spectrum of mental health issues, including mood disorders, anxiety disorders, schizophrenia, and developmental disorders. By fostering collaboration among researchers, clinicians, and the community, NIMH aims to translate scientific discoveries into effective interventions and improve mental health outcomes for individuals across the lifespan. Through its commitment to rigorous research methodologies and ethical standards, NIMH plays a pivotal role in shaping the future of mental health care and policy.

Locations

Bethesda, Maryland, United States

Patients applied

0 patients applied

Trial Officials

Daniel S Pine, M.D.

Principal Investigator

National Institute of Mental Health (NIMH)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported