Actively Recruiting

Phase 2
Age: 8Years - 17Years
All Genders
ID06595953

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

Age: 8Years - 17Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Run-in Period

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

Treatment

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

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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

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