Protocol Details
Phase II Efficacy Study of Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety
This study is currently recruiting participants.
Summary
Number |
001937-M |
Sponsoring Institute |
National Institute of Mental Health (NIMH) |
Recruitment Detail |
Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 8 Years
Max Age: 17 Years |
Referral Letter Required |
No |
Population Exclusion(s) |
Pregnant Women;
Non-English Speaking |
Keywords |
Cognitive-behavioral therapy;
Attention;
Anxiety;
Children;
Adolescents |
Recruitment Keyword(s) |
None |
Condition(s) |
Psychiatric Disorders;
Anxiety Disorders |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
Behavioral: Gaze-Contingent Music Reward Therapy
|
Supporting Site |
National Institute of Mental Health |
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.
Eligibility
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
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT06595953