[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557428":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":55,"collaborators":18,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":18,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":18,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":39,"whyStopped":18,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Post Graduate Institute of Medical Education and Research, Chandigarh","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","Standard therapy with intervention module (Module comprised of Cognitive retraining exercise and cognitive behavioral therapy- pen and paper based) Duration - 8 weeks Frequency - once in a week for 2 hours. In person delivery of intervention in a group of 5 patients.",[13],"Behavioral: Neurocognitive and psychosocial intervention module",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Standard therapy without intervention module",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Neurocognitive and psychosocial intervention module","The module comprised of various intervention methods that include- I. Cognitive Retraining: Pen-and-paper-based cognitive rehabilitation program that is divided into five hierarchically graded modules: Attention, Visual Processing, Memory, Information Processing, and Executive Functions.\n\n2.Cognitive-behavioral interventions. Cognitive-behavioral interventions would be carried out for activities scheduling, problem-solving teachings, anger management techniques, modifications of negative cognitions, stigma address measures, and irrational beliefs about epilepsy, etc.\n\n3\\. Marital\u002FFamily counseling: Marital\u002Ffamily counseling would be done to ensure family understanding of the patient's illness, his\u002Fher treatment, prognosis, and outcome. Family complications arising due to illness would also be discussed. Individual and personal needs of the husband, a wife will also be discussed.",[9],[26],{"name":27,"affiliation":28,"role":29},"Dr. Parampreet Singh Kharbanda, MD, DM","PGIMER, Chandigarh","STUDY_CHAIR",[31],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Neetu Choudhary, Ph.D","CONTACT","08800136337","Neetumeel@gmail.com",[37],{"facility":38,"status":39,"city":40,"state":18,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Post Graduate institute of medical education and research , Chandigarh","RECRUITING","Chandigarh","160012","India","IN",{"type":45,"coordinates":46},"Point",[47,48],76.7884,30.73629,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":53,"phoneExt":18,"email":54},"Dr parampreet singh kharbanda, MD,DM","7087009696","neuroparam@hotmail.com",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Neetu Choudhary","Principal Investigator","100557428","a-neuro-cognitive-and-psychosocial-intervention-module-in-people-with-epilepsy-100557428",false,"NCT06537986","A Neuro-cognitive and Psychosocial Intervention Module in People With Epilepsy","Testing the Efficacy of a Neuro-cognitive and Psychosocial Intervention Module in People With Epilepsy","Inclusion Criteria:\n\n1. Participants of 18 - 45 years of age.\n2. either gender\n3. Willing to participate and sign the informed consent\n\nExclusion Criteria:\n\n1. Patients with other neurological disorders\n2. any other trial at inclusion\n3. should not have any major psychiatric disorder\n4. pregnant and lactating mothers\n5. also, patients who would not be giving informed consent\n6. Patients with intellectual disabilities.","ALL","18 Years","45 Years",{"count":70,"type":71},60,"ESTIMATED","INTERVENTIONAL",[74],"NA","Patients with epilepsy, especially drug-resistant epilepsy, have a lot of cognitive \\& psycho-social issues. There is little evidence pertaining to the efficacy of the various cognitive-behavioral interventions and cognitive retraining modules used in epilepsy patients in the Indian context. The real value of these interventions needs further consolidation in terms of its assessment and efficacy. The available literature is scanned and having limitations in terms of assessment tool used, sample size, and also lacks a broader spectrum of psychosocial interventions used. In view of the above limitations, we plan to specially develop \\& test a Neuro-cognitive and psychosocial intervention module, based on the deficits found in these domains that will help DRE patients to improve their quality of life. This module will be covering not only the broader spectrum of assessment tools but also varieties of interventions. This module will help in planning the future needs of epileptic patients in terms of not only medication but also guide us in choosing the kind of interventions to be used with a particular patient or group of patients.",[77],"Drug Resistant Epilepsy",[79,80,81,82],"Epilepsy,","Neurocognitive","Psychosocial","module","2024-07-31",{"date":85,"type":86},"2024-08-05","ACTUAL",{"date":88,"type":86},"2022-02-15",{"date":90,"type":71},"2025-04-30",{"name":5,"class":6},1]