Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595953
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase II Efficacy Study of Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09-23
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
Study Description
This study compares the efficacy of Gaze-Contingent Music Reward Therapy GCMRT and a control form of GCMRT both added to concurrent therapy Efficacy will be examined for the severity of clinician-rated anxiety in medication-free children and adolescents with an anxiety disorder For concurrent therapy all patients will receive Cognitive Behavioral Therapy CBT With this design efficacy is based on comparison of groups receiving CBT augmented with either active or control forms of GCMRT A total of 150 patients will be enrolled in the study and will begin CBT therapy for three weeks By the end of week three participants will be randomly assigned in a one-to-one ratio to the two forms of GCMRT which they will receive along with CBT for 9 weeks From among the 150 patients who enroll in the study 120 are expected to be randomized to one of the two forms of GCMRT
Objectives
Primary Objective To test the efficacy of Gaze-Contingent Music Reward Therapy GCMRT for the augmentation of Cognitive Behavioral Therapy CBT treatment for pediatric anxiety disorders
Secondary Objective To test for efficacy on secondary outcome measures as well as to test for moderation and mediation of efficacy by measures of attention bias
Endpoints
Primary Endpoint The severity of clinician-rated anxiety blinded to the GCMRT condition on the Pediatric Anxiety Rating Scale PARS
Secondary Endpoints Overall treatment response on the clinician-rated Clinician Global Impression scale and rated symptoms of anxiety on the Screen for Child Anxiety Related Disorders SCARED scale as completed by parents and patients
This study compares the efficacy of Gaze-Contingent Music Reward Therapy GCMRT and a control form of GCMRT both added to concurrent therapy Efficacy will be examined for the severity of clinician-rated anxiety in medication-free children and adolescents with an anxiety disorder For concurrent therapy all patients will receive Cognitive Behavioral Therapy CBT With this design efficacy is based on comparison of groups receiving CBT augmented with either active or control forms of GCMRT A total of 150 patients will be enrolled in the study and will begin CBT therapy for three weeks By the end of week three participants will be randomly assigned in a one-to-one ratio to the two forms of GCMRT which they will receive along with CBT for 9 weeks From among the 150 patients who enroll in the study 120 are expected to be randomized to one of the two forms of GCMRT
Objectives
Primary Objective To test the efficacy of Gaze-Contingent Music Reward Therapy GCMRT for the augmentation of Cognitive Behavioral Therapy CBT treatment for pediatric anxiety disorders
Secondary Objective To test for efficacy on secondary outcome measures as well as to test for moderation and mediation of efficacy by measures of attention bias
Endpoints
Primary Endpoint The severity of clinician-rated anxiety blinded to the GCMRT condition on the Pediatric Anxiety Rating Scale PARS
Secondary Endpoints Overall treatment response on the clinician-rated Clinician Global Impression scale and rated symptoms of anxiety on the Screen for Child Anxiety Related Disorders SCARED scale as completed by parents and patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None