Status:
RECRUITING
Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Psychiatric Disorders
Anxiety Disorders
Eligibility:
All Genders
8-17 years
Phase:
PHASE2
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 i...
Detailed Description
Study Description: This study compares the efficacy of Gaze-Contingent Music Reward Therapy (GCMRT) and a control form of GCMRT, both added to concurrent therapy. Efficacy will be examined for the se...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Ability of subject and parent to understand the study and the willingness to assent/consent into the study.
- Males and females; Age 8-17
- 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
- Willingness to adhere to 12 weekly in-person sessions of CBT
- Enrolled in Protocol 01-M-0192
- Subjects must speak, read and write English to be able to participate
- 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:
- Current use of any psychotropic medication
- Ongoing participation in another treatment or intervention study
- Ongoing mental health treatment outside of NIH
- Any mental health diagnosis aside from an anxiety disorder as determined by the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
- Any serious medical conditions
- Restrictions that preclude in-person attendance of therapy
Exclusion
Key Trial Info
Start Date :
December 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06595953
Start Date
December 4 2024
End Date
October 1 2029
Last Update
December 11 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892