Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Mental Health (NIMH)
Study ID
NCT06595953
Phase
PHASE2
Status
Recruiting
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Conditions

  • Anxiety Disorders
  • Psychiatric Disorders

Eligibility Criteria

Sex
ALL
Age
8 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Gaze-Contingent Music Reward Therapy — BEHAVIORAL
    All subjects will receive CBT and will be randomized to either active or control forms of GCMRT. This involves the monitoring of a patient s eye-movements during the free-viewing of computer-displayed matrices of faces expressing various emotions in tandem with the playing of pleasant music. In the active form of the therapy, music stops when subjects view negative valence faces, whereas in the control condition, music plays continuously. Subjects undergo 12 weeks of CBT, where GCMRT is delivered in the last eight weeks of therapy.

Study Details

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.

Key Dates

Start date
Dec 4, 2024
Status verified
Sep 2025
Primary completion
Oct 1, 2029
Completion
Oct 1, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active-GCMRT
    In the active form of the therapy, music stops when subjects view negative valence faces.
  • Sham Comparator: Sham-GCMRT
    In the control condition, music plays continuously.

Primary Outcome Measure

Pediatric Anxiety Rating Scale (PARS) [ Time Frame: Week 1-13. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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