Gaze-Contingent Music Therapy to Help Kids with Anxiety

Phase II Efficacy Study of Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety

This study is testing if adding a special music therapy to regular talk therapy can help kids and teens with anxiety feel better.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 8 Years to 17 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT06595953 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of Gaze-Contingent Music Reward Therapy (GCMRT) when combined with Cognitive Behavioral Therapy (CBT) for children and adolescents suffering from anxiety disorders. Participants aged 8 to 17 will receive weekly CBT sessions for four weeks, followed by random assignment to either active or control GCMRT for an additional nine weeks. The primary goal is to assess the reduction in anxiety severity as rated by clinicians using the Pediatric Anxiety Rating Scale (PARS). The study aims to determine if the addition of GCMRT enhances the outcomes of standard CBT.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 8 to 17 with a confirmed diagnosis of separation anxiety disorder, generalized anxiety disorder, or social anxiety disorder.

Not a fit: Patients who do not have a diagnosis of the specified anxiety disorders or who are currently on medication may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes for children and adolescents with anxiety disorders.

How similar studies have performed: While the combination of GCMRT with CBT is a novel approach, previous studies have shown that music therapy can be beneficial in treating anxiety, suggesting potential for success.

Eligibility criteria

* INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Ability of subject and parent to understand the study and the willingness to assent/consent into the study.
2. Males and females; Age 8-17
3. Clinician confirmed diagnosis of ongoing separation anxiety disorder, generalized anxiety disorder, or social anxiety disorder. A clinician will review a KSADS-PL DSM-5 (November 2016) (Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children) interview, which will have occurred on Protocol 01-M-0192, to confirm diagnosis
4. Willingness to adhere to 12 weekly in-person sessions of CBT
5. Enrolled in Protocol 01-M-0192
6. Subjects must speak, read and write English to be able to participate
7. All subjects will have IQ\>70 as assessed by a WASI or assessment by trained clinical staff which will have occurred under Protocol 01-M-0192

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Current use of any psychotropic medication
2. Ongoing participation in another treatment or intervention study
3. Ongoing mental health treatment outside of NIH
4. Any mental health diagnosis aside from an anxiety disorder as determined by the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
5. Any serious medical conditions
6. Restrictions that preclude in-person attendance of therapy

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Daniel S Pine, M.D. — National Institute of Mental Health (NIMH)
• Study coordinator: Daniel S Pine, M.D.

Conditions: Psychiatric Disorders, Anxiety Disorders, Cognitive-behavioral therapy, Attention, Anxiety, Children, Adolescents