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Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety

RecruitingPhase 2Ages 8 Years - 17 YearsAllNational Institute of Mental Health (NIMH)
NCT06595953 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 som

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📋 Eligibility rules (as published)
* 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
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What it tests

  • Gaze-Contingent Music Reward Therapy
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Where

1 site
National Institutes of Health Clinical Center
Bethesda, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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