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NCT06595953 · ClinicalTrials.gov registry record · Phase 2
Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety
A Phase 2 study of Anxiety Disorders and Psychiatric Disorders, sponsored by National Institute of Mental Health (NIMH).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT06595953 is a Phase 2 study of Anxiety Disorders and Psychiatric Disorders that is actively recruiting participants, run by National Institute of Mental Health (NIMH). The registered enrollment target is 150 participants, below the 1,138-participant average among 84 other Anxiety Disorders trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06595953, a Phase 2 study of Anxiety Disorders and Psychiatric Disorders, is actively recruiting participants, sponsored by National Institute of Mental Health (NIMH).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study 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 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.
Conditions Studied
Interventions
- BEHAVIORAL Gaze-Contingent Music Reward Therapy
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-12-04 |
| Est. Completion | 2029-10-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06595953
The ClinicalTrials.gov registry entry for NCT06595953 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,138-participant average among 84 other Anxiety Disorders trials with a reported enrollment target (87% lower). The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Anxiety Disorders appearing as the primary indexed condition, and to 1 intervention - of which Gaze-Contingent Music Reward Therapy is the first listed.
NCT06595953 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06595953 about?
NCT06595953 is a clinical study titled "Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety". 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. ...
What is the current status of trial NCT06595953?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2024-12-04. Estimated completion is 2029-10-01.
What conditions does trial NCT06595953 study?
This clinical trial studies the following conditions: Anxiety Disorders, Psychiatric Disorders.
What interventions are being tested in trial NCT06595953?
The interventions under investigation include: Gaze-Contingent Music Reward Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT06595953?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06595953 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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