Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age8-17
SponsorNational Institute of Mental Health (NIMH)
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Ability of subject and parent to understand the study and the willingness to assent/consent into the study.
Males and females; Age 8-17
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
Willingness to adhere to 12 weekly in-person sessions of CBT
Disqualifiers
Current use of any psychotropic medication
Ongoing participation in another treatment or intervention study
Ongoing mental health treatment outside of NIH
Any mental health diagnosis aside from an anxiety disorder as determined by the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
Trial design
Design model
Parallel
Treatments tested in this trial
Gaze-Contingent Music Reward Therapy
BehavioralAll subjects will receive CBT and will be randomized to either active or control forms of GCMRT. This involves the monitoring of a patient s eye-movements during the free-viewing of computer-displayed matrices of faces expressing various emotions in tandem with the playing of pleasant music. In the active form of the therapy, music stops when subjects view negative valence faces, whereas in the control condition, music plays continuously. Subjects undergo 12 weeks of CBT, where GCMRT is delivered in the last eight weeks of therapy.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Active-GCMRTActive comparator 1 intervention
Group B: Sham-GCMRTSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pediatric Anxiety Rating Scale (PARS)
Completed by the clinician.
Time frame
Week 1-13.Secondary outcomes
1
Clinical Global Impression Scale (CGI)
Completed by the clinician.
Time frame
Week 1-13.2
Screen for Child Anxiety Related Disorders (SCARED)
Completed by parents and patients.
Time frame
Week 1, 4, and 13.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov