Actively Recruiting
Phase II Study of Gaze-Contingent Music Reward Therapy Added to Cognitive Behavioral Therapy for Pediatric Anxiety Disorders
Led by National Institute of Mental Health (NIMH) · Updated on 2026-06-03
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether adding Gaze-Contingent Music Reward Therapy (GCMRT) to Cognitive Behavioral Therapy (CBT) improves treatment for children and teenagers aged 8 to 17 with separation anxiety disorder, generalized anxiety disorder, or social anxiety disorder. Anxiety disorders can cause long-term physical and mental health issues, and current treatments like medications and CBT work in only about half of cases. This study aims to compare the effectiveness of CBT alone versus CBT combined with GCMRT in a phase II randomized trial. Participants will attend weekly sessions for 12 weeks, starting with CBT alone for the first 4 weeks. After this, they will be randomly assigned to receive either an active form of GCMRT, where music stops when they look at negative facial expressions, or a control form where music plays continuously. This therapy is computer-based and involves tracking eye movements as participants view faces showing different emotions. Both groups continue CBT during the 8 weeks of GCMRT. Throughout the study, participants will complete questionnaires about their anxiety symptoms and behavior and perform computer tasks involving eye tracking and reaction times. Assessments will be done at the start, weekly during therapy, and at a final visit in week 13. The main outcome measured is the severity of anxiety rated by clinicians using the Pediatric Anxiety Rating Scale (PARS). Secondary measures include overall clinical improvement and symptoms reported by parents and patients. Each visit lasts about 2 hours, and participants must be medication-free and enrolled in a related protocol to take part.
CONDITIONS
Brief Title
Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability of subject and parent to understand the study and willingness to assent/consent
- Male or female participants aged 8 to 17 years
- Clinician confirmed diagnosis of separation anxiety disorder, generalized anxiety disorder, or social anxiety disorder
- Willingness to attend 12 weekly in-person Cognitive Behavioral Therapy sessions
- Enrollment in Protocol 01-M-0192
- Ability to speak, read, and write English
- IQ greater than 70 as assessed by WASI or clinical staff under Protocol 01-M-0192
You will not qualify if you...
- Current use of any psychotropic medication
- Participation in another treatment or intervention study
- Receiving mental health treatment outside of NIH
- Any mental health diagnosis other than an anxiety disorder
- Presence of any serious medical condition
- Restrictions preventing in-person attendance of therapy sessions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants begin Cognitive Behavioral Therapy (CBT) without Gaze-Contingent Music Reward Therapy (GCMRT) for initial 3 weeks.
Weekly visits for 3 weeks
Duration - 9 weeks
Participants receive Cognitive Behavioral Therapy (CBT) combined with either active or control forms of Gaze-Contingent Music Reward Therapy (GCMRT) for 9 weeks.
Weekly visits for 9 weeks
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
D
Daniel S Pine, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here