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Music Therapy + CBT for Pediatric Anxiety

Phase 2
Waitlist Available
Led By Daniel S Pine, M.D.
Research Sponsored by National Institute of Mental Health (NIMH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and females aged 8-17
Clinician confirmed diagnosis of ongoing separation anxiety disorder, generalized anxiety disorder, or social anxiety disorder
Must not have
Restrictions that preclude in-person attendance of therapy
Current use of any psychotropic medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1, 4, and 13.

Summary

This trial aims to see if a new therapy called gaze-contingent music reward therapy (GCMRT) combined with cognitive behavioral therapy (CBT) is more effective in treating anxiety disorders in children

Who is the study for?
This trial is for children aged 8 to 17 with separation, generalized, or social anxiety disorder. They must already be part of protocol 01-M-0192 and can commit to weekly clinic visits for CBT sessions and computer-based tasks over a period of about 13 weeks.
What is being tested?
The study tests if adding Gaze-Contingent Music Reward Therapy (GCMRT) to Cognitive Behavioral Therapy (CBT) is more effective than CBT alone in treating pediatric anxiety. Participants will engage in both therapies with regular questionnaires and tasks tracking their progress.
What are the potential side effects?
Since the intervention involves non-invasive therapy methods like music reward therapy and cognitive behavioral talks, there are no direct medical side effects expected from this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 8 and 17 years old.
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I have been diagnosed with separation anxiety, generalized anxiety, or social anxiety.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot attend therapy sessions in person due to restrictions.
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I am currently taking medication for mental health issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1, 4, and 13.
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1, 4, and 13. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pediatric Anxiety Rating Scale (PARS)
Secondary study objectives
Clinical Global Impression Scale (CGI)
Screen for Child Anxiety Related Disorders (SCARED)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active-GCMRTActive Control1 Intervention
In the active form of the therapy, music stops when subjects view negative valence faces.
Group II: Sham-GCMRTPlacebo Group1 Intervention
In the control condition, music plays continuously.

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)Lead Sponsor
2,918 Previous Clinical Trials
2,739,815 Total Patients Enrolled
36 Trials studying Generalized Anxiety Disorder
8,692 Patients Enrolled for Generalized Anxiety Disorder
Daniel S Pine, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
7 Previous Clinical Trials
8,338 Total Patients Enrolled
~100 spots leftby Oct 2029
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