Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06595953 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 113 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Re-verified, no change to tracked fields
  2. Minor Re-verified, no change to tracked fields
  3. Minor Re-verified, no change to tracked fields
  4. Minor Re-verified, no change to tracked fields
  5. Minor New version filed on ClinicalTrials.gov
  6. Minor 45 versions Re-verified since Apr 10, 2025, no change to tracked fieldsv64-v108
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.
Trial Details
NCT Number NCT06595953
Lead Sponsor National Institute of Mental Health (NIMH)
Conditions
(from sponsor)
Psychiatric Disorders, Anxiety Disorders
Related terms Anxiety Disorders, Mental Disorders
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov