[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100446656":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":31,"centralContacts":40,"locations":46,"responsibleParty":68,"collaborators":72,"id":76,"slug":31,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":31,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":31,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":31,"overallStatus":49,"whyStopped":31,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,14,18,23,27],{"label":9,"type":10,"description":11,"interventionNames":12},"CPT- Pain relief lotion","EXPERIMENTAL","During the initial visit participant will do the cold pressor test twice to assess catastrophic symptom expectations. After completing the 1st CPT, participants will be randomized to receive a pain relief lotion or pain sensitivity lotion. Participants will then repeat the CPT with the lotion applied to their hand.",[13],"Behavioral: ReACT",{"label":15,"type":10,"description":16,"interventionNames":17},"CPT- Pain sensitivity lotion","During the initial visit participant will do the cold pressor test twice to assess catastrophic symptom expectation. After completing the 1st CPT, participants will be randomized to receive a pain relief lotion or pain sensitivity lotion. Participants will then repeat the CPT with the lotion applied to their hand.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"ReACT for PNES- Booster therapy sessions","ACTIVE_COMPARATOR","After completing the 12 therapy sessions, half of the participants will be randomized to receive 2 booster therapy sessions, 3 months and 9 months after the 12th ReACT treatment session.",[13],{"label":24,"type":10,"description":25,"interventionNames":26},"ReACT for PNES- No Booster therapy sessions","After completing the 12 ReACT treatment sessions, half of the participants will be randomized to not receive the 2 booster therapy sessions.",[13],{"label":28,"type":29,"description":30,"interventionNames":31},"Healthy Control","NO_INTERVENTION","Healthy controls are matched to participants with PNES based on age (+ or - 1 year), gender, race and family income. 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,[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"BEHAVIORAL","ReACT","ReACT is a novel cognitive behavioral treatment and is a PNES intervention that targets sense of control and catastrophic symptom expectations",[9,15,19,24],[39],"Retraining and Control Therapy",[41],{"name":42,"role":43,"phone":44,"phoneExt":31,"email":45},"Aaron Fobian, PhD","CONTACT","205-934-2241","afobian@uabmc.edu",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Sparks Center Office of Psychiatric Research","RECRUITING","Birmingham","Alabama","35294","United States",{"type":55,"coordinates":56},"Point",[57,58],-86.80249,33.52066,{"lat":58,"lon":57},[61,65],{"name":62,"role":43,"phone":63,"phoneExt":31,"email":64},"Badhma Valaiyapathi, MD","2059754205","bvalaiyapathi@uabmc.edu",{"name":42,"role":43,"phone":66,"phoneExt":31,"email":67},"2059342241","afobian@uab.edu",{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Aaron Fobian","Associate Professor",[73],{"name":74,"class":75},"National Institute of Mental Health (NIMH)","NIH","100446656",false,"NCT05096273","Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES","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)","Inclusion Criteria:\n\n* 9-18 years old.\n* Diagnosis of psychogenic non-epileptic seizures by a medical doctor using video-EEG.\n* Family member (parent 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\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":87,"type":88},68,"ESTIMATED","INTERVENTIONAL",[91],"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 medical explanation). 11-18-year-olds diagnosed with PNES will engage in twelve sessions of ReACT. 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 will occur 7 days before treatment, 7 days after 8th treatment session and 7 days after 12th treatment session. Participants will also complete long term follow-up visits via HIPAA-compliant Zoom at 6 months and 12 months after the 12th treatment session where participants will complete questionnaires. PNES frequency will be measured from 30 days before to 12 months after treatment.",[94],"Convulsion, Non-Epileptic","2025-08-26",{"date":97,"type":98},"2025-09-03","ACTUAL",{"date":100,"type":98},"2021-10-28",{"date":102,"type":88},"2026-12-31",{"name":5,"class":6},1]