[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516633":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":36,"centralContacts":40,"locations":45,"responsibleParty":64,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":28,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":24,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":47,"whyStopped":24,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"ReACT Intervention","EXPERIMENTAL","At the end of the baseline visit, half of the participants will be randomized to receive Retraining and Control Therapy (ReACT)",[13],"Behavioral: ReACT",{"label":15,"type":16,"description":17,"interventionNames":18},"Supportive Therapy","ACTIVE_COMPARATOR","At the end of the baseline visit, half of the participants will be randomized to receive supportive therapy",[19],"Behavioral: Supportive Therapy",{"label":21,"type":22,"description":23,"interventionNames":24},"Healthy Control","NO_INTERVENTION","Healthy controls are ages 12-18 with no significant comorbid medical or mental health conditions. Healthy controls and their parent come for 1 baseline laboratory visit and a follow up visit 13 weeks after the baseline visit. These visits will be identical to baseline and follow-up visits of children with PNES.",null,[26,33],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BEHAVIORAL","ReACT","ReACT is a novel cognitive behavioral treatment and is a PNES intervention that targets sense of control and catastrophic symptom expectations. ReACT consists of 12 sessions of therapy focused on teaching adolescents to regain control of their body through managing thoughts and behaviors that reinforce the PNES and return to previous activities. It teaches parents how to respond to PNES in a manner that encourages the adolescents to regain control of their body. The PNES is explained as behaviors learned through classical and operant conditioning.",[9],[32],"Retraining and Control Therapy",{"type":27,"name":15,"description":34,"armGroupLabels":35,"otherNames":24},"The supportive therapy treatment consists of 12 sessions of therapy focused on discussing daily difficulties and\u002For stressors they experience and identifying stress triggers for PNES. The PNES is explained as physical manifestations of psychological stress.",[15],[37],{"name":38,"affiliation":5,"role":39},"Aaron Fobian, PhD","PRINCIPAL_INVESTIGATOR",[41],{"name":38,"role":42,"phone":43,"phoneExt":24,"email":44},"CONTACT","205-934-2241","afobian@uabmc.edu",[46],{"facility":5,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-86.80249,33.52066,{"lat":57,"lon":56},[60],{"name":61,"role":42,"phone":62,"phoneExt":24,"email":63},"Badhma Valaiyapathi, MBBS, MPH","205-975-4205","drbadhma@uab.edu",{"type":39,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Aaron Fobian","Associate Professor",[68],{"name":69,"class":70},"National Institute of Mental Health (NIMH)","NIH","100516633","retraining-and-control-therapy-react-r33-phase-100516633",false,"NCT06007053","Retraining and Control Therapy (ReACT) R33 Phase","Retraining and Control Therapy (ReACT): Sense of Control and Catastrophic Symptom Expectations as Targets of a Cognitive Behavioral Treatment for Pediatric Psychogenic Non-epileptic Seizures (PNES) - R33 Phase","Inclusion Criteria:\n\n* 11-18 years old.\n* Diagnosis of psychogenic non-epileptic seizures by a medical doctor using video-EEG.\n* Family member (parent\u002Fguardian if a minor) willing to participate and that the subject with PNES chooses.\n\nExclusion Criteria:\n\n* Comorbid Epilepsy\n* Less than 4 PNES per month\n* Other paroxysmal nonepileptic events (e.g. episodes related to hypoxic-ischemic phenomena, sleep disorders or migraine-associated disorders)\n* Participation in other therapy during the study\n* Severe intellectual disability\n* Severe mental illness (delusions\u002Fhallucinations)\n\nExclusion for CPT:\n\n* Blood pressure \\>130\u002F80 mmHg for adolescents greater than or equal to 13 years old\n* Either systolic and\u002For diastolic blood pressure greater than or equal to 95% based on sex and age for children less than 13 years old",true,"ALL","11 Years","18 Years",{"count":83,"type":84},160,"ESTIMATED","INTERVENTIONAL",[87],"NA","The purpose of this study is to assess sense of control and catastrophic symptom expectations as targets for Retraining and Control Therapy (ReACT- an intervention focused on changing behaviors and thoughts) for treatment of pediatric psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no correlated epileptiform activity). 11-18-year-olds diagnosed with PNES will engage in twelve sessions of either ReACT or supportive therapy. Sense of control over actions will be measured by the magic and turbulence task, a well-validated measure of sense of control. Participants will complete the cold pressor test (CPT) in which participants hold their hand in cool water for as long as possible up to 3 minutes. Catastrophic symptom expectations in response to the CPT will be measured by Pain Catastrophizing Scale for Children (PCS-C), pain tolerance (time with hand in water) and cortisol response. Target assessments occur 7 days before treatment, 7 days after 12th treatment session, and 2 months after the 12th treatment session. Long term follow-up assessments will occur 6 months and 12 months after the 12th treatment session. PNES frequency will be measured from 30 days before to 12 months after treatment.",[90],"Convulsion, Non-Epileptic",[92,28],"Supportive therapy","2026-03-16",{"date":95,"type":96},"2026-03-17","ACTUAL",{"date":98,"type":96},"2024-03-09",{"date":100,"type":84},"2026-12-31",{"name":5,"class":6},1]