[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06595953":3,"trial-entities:NCT06595953":94,"trial-summary:NCT06595953":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":42,"secondary_outcomes":47,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":62,"locations":64,"central_contacts":81,"overall_officials":86,"references":89,"see_also_links":90},"NCT06595953","10001937","Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety","Phase II Efficacy Study of Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety","RECRUITING","2029-10-01","2026-07-16","2026-08-13","2024-12-04","National Institute of Mental Health (NIMH)","NIH",null,"Background:\n\nAnxiety 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.\n\nObjective:\n\nTo find out whether GCMRT combined with CBT is more effective than CBT alone.\n\nEligibility:\n\nChildren 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.\n\nDesign:\n\nParticipants 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.\n\nFor the next 8 weeks, participants will participate in both CBT and 1 of 2 types of GCMRT.\n\nGCMRT 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.\n\nParticipants will have a final visit in week 13. They will take questionnaires. They will do final research tasks. Each visit lasts about 2 hours.","Study Description:\n\nThis 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.\n\nObjectives:\n\nPrimary 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.\n\nSecondary 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.\n\nEndpoints:\n\nPrimary Endpoint: The severity of clinician-rated anxiety, blinded to the GCMRT condition, on the Pediatric Anxiety Rating Scale (PARS).\n\nSecondary 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.",[19,20],"Psychiatric Disorders","Anxiety Disorders",[22,23,24,25,26],"Cognitive-behavioral therapy","Attention","Anxiety","Children","Adolescents","INTERVENTIONAL","TREATMENT",[30],"PHASE2",{"count":32,"type":33},150,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39},"BEHAVIORAL","Gaze-Contingent Music Reward Therapy","All 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.",[40,41],"Active-GCMRT","Sham-GCMRT",[43],{"measure":44,"description":45,"timeFrame":46},"Pediatric Anxiety Rating Scale (PARS)","Completed by the clinician.","Week 1-13.",[48,50],{"measure":49,"description":45,"timeFrame":46},"Clinical Global Impression Scale (CGI)",{"measure":51,"description":52,"timeFrame":53},"Screen for Child Anxiety Related Disorders (SCARED)","Completed by parents and patients.","Week 1, 4, and 13.","ALL","8 Years","17 Years",false,{"inclusion":59,"exclusion":60,"raw_text":61},[],[],"* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Ability of subject and parent to understand the study and the willingness to assent\u002Fconsent into the study.\n2. Males and females; Age 8-17\n3. 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\n4. Willingness to adhere to 12 weekly in-person sessions of CBT\n5. Enrolled in Protocol 01-M-0192\n6. Subjects must speak, read and write English to be able to participate\n7. 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\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Current use of any psychotropic medication\n2. Ongoing participation in another treatment or intervention study\n3. Ongoing mental health treatment outside of NIH\n4. Any mental health diagnosis aside from an anxiety disorder as determined by the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)\n5. Any serious medical conditions\n6. Restrictions that preclude in-person attendance of therapy",[63],"CHILD",[65],{"facility":66,"status":8,"city":67,"state":68,"zip":69,"country":70,"contacts":71,"geoPoint":78},"National Institutes of Health Clinical Center","Bethesda","Maryland","20892","United States",[72],{"name":73,"role":74,"phone":75,"phoneExt":76,"email":77},"NIH Clinical Center Office of Patient Recruitment (OPR)","CONTACT","800-411-1222","TTY dial 711","ccopr@nih.gov",{"lat":79,"lon":80},38.98067,-77.10026,[82],{"name":83,"role":74,"phone":84,"email":85},"Daniel S Pine, M.D.","(301) 594-1318","daniel.pine@nih.gov",[87],{"name":83,"affiliation":13,"role":88},"PRINCIPAL_INVESTIGATOR",[],[91],{"label":92,"url":93},"NIH Clinical Center Detailed Web Page","https:\u002F\u002Fclinicalstudies.info.nih.gov\u002Fcgi\u002Fdetail.cgi?A_001937-M.html",{"nct_id":4,"conditions":95,"biomarkers":99},[96,97,98],"Generalized Anxiety Disorder","Separation Anxiety Disorder","Social Anxiety Disorder",[],{"nct_id":4,"found":101,"summary":102,"prompt_version":112},true,{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This interventional study plans to enroll 150 participants. All participants will receive CBT and will then be randomly assigned to receive either active or control forms of GCMRT.","completed","Gaze-Contingent Music Therapy for Pediatric Anxiety","This study is looking at a new way to help children and teenagers (ages 8-17) with anxiety disorders like separation anxiety, generalized anxiety disorder, or social anxiety. It combines standard talk therapy called Cognitive Behavioral Therapy (CBT) with something called Gaze-Contingent Music Reward Therapy (GCMRT). GCMRT involves watching faces on a computer screen while pleasant music plays, and your eye movements are tracked. Researchers want to see if adding GCMRT to CBT works better than CBT alone to reduce anxiety. The study plans to enroll 150 participants, and success will be measured by changes in anxiety levels using a tool called the Pediatric Anxiety Rating Scale (PARS) over 13 weeks. The current status of this study is unclear.","Your anxiety levels will be measured weekly for 13 weeks.",118,"You would attend the clinic once a week for 4 weeks for CBT. After 3 weeks of CBT, you would be randomly assigned to receive GCMRT along with CBT for 9 more weeks.","Not stated in the trial record.",[37],"v2"]