[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04414215":3,"trial-entities:NCT04414215":91,"trial-summary:NCT04414215":95},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":14,"eligibility_criteria":49,"std_ages":62,"locations":64,"central_contacts":86,"overall_officials":88,"references":89,"see_also_links":90},"NCT04414215","00001377","Cognitive Training for Emotion Regulation in Psychotic Disorders","RECRUITING","2029-12-31","2025-02","2025-02-05","2020-06-01","University of Georgia","OTHER",false,"The current study examines the efficacy of a cognitive training intervention for improving emotion regulation in psychotic disorders. it is hypothesized that the cognitive training program will enhance prefrontal activation, leading to enhanced emotion regulation.","Psychotic disorders are serious and debilitating mental illnesses that incur substantial suffering for patients and present major challenges to our health care system. Difficulties with emotion regulation (i.e., the ability to control the emotion response using strategies) significantly predict the development and maintenance of psychotic symptoms and poor community-based functional outcomes. Recent neuroimaging research indicates that hypofrontality may underlie these deficits. Unfortunately, there is no accepted technique for remediating these emotion regulation abnormalities in psychotic disorders. Recent advances from the field of cognitive neuroscience provide hope for a resolution to this critical unmet need in psychotic disorder therapeutics, demonstrating that brief computerized cognitive training interventions are capable of improving emotion regulation ability by targeting neural activation in the prefrontal cortex. The goal of the proposed project is to determine whether an emotional working memory cognitive training program is effective for remediating emotion regulation abnormalities and associated clinical outcomes in people with psychotic disorders. Outpatients with psychotic disorders will be randomly assigned to either an emotional working memory training (n = 35) or placebo (P: n = 35) cognitive training control intervention delivered via an app on a smart phone for 30 days. The primary aim is to determine whether the emotional working memory intervention successfully engages the target mechanism and enhances prefrontal activation on a non-trained emotion regulation transfer task beyond a pre-specified effect size criterion. Results will also be used to determine the treatment duration (15 vs. 30 days) that most effectively and efficiently improves the target.",[18,19],"Schizophrenia","Schizo Affective Disorder",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},70,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Emotional working memory training","Participants will complete an emotional working memory n-back training program that progressively increases difficulty and has been shown to enhance prefrontal activity in a non-psychiatric sample",[34],"Cognitive training",{"type":30,"name":36,"description":37,"armGroupLabels":38},"Placebo working memory training","Working memory training that does not involve emotional stimuli using an N-back training program",[39],"Placebo training",[41],{"measure":42,"description":43,"timeFrame":44},"Prefrontal blood oxygen level dependent activation in the prefrontal cortex","blood oxygen level dependent change in the prefrontal cortex as measured using functional magnetic resonance imaging. This will be calculated as a change from baseline to follow-up on the contrast score (unpleasant passive viewing condition - reappraisal) on the emotion regulation reappraisal task","Change from baseline to 15 days or 30 days",[],"ALL","18 Years","60 Years",{"inclusion":50,"exclusion":56,"raw_text":61},[51,52,53,54,55],"diagnostic and statistical manual fifth edition diagnosis of schizophrenia or schizoaffective disorder","18-60 years old","speaks English","premorbid intelligence quotient \\> 70","clinically stable as indicated by no antipsychotic medication changes in the last month or if on depot, no change in the past 2 months.",[57,58,59,60],"history of intellectual disability or neurological disorder","history of traumatic brain injury with loss of consciousness \\> 10 minutes or behavioral sequelae","substance use disorder within the last 6 months (other than nicotine)","4\\) endorsement of MRI exclusion factors","Inclusion Criteria:\n\n* diagnostic and statistical manual fifth edition diagnosis of schizophrenia or schizoaffective disorder\n* 18-60 years old\n* speaks English\n* premorbid intelligence quotient \\> 70\n* clinically stable as indicated by no antipsychotic medication changes in the last month or if on depot, no change in the past 2 months.\n\nExclusion Criteria:\n\n* history of intellectual disability or neurological disorder\n* history of traumatic brain injury with loss of consciousness \\> 10 minutes or behavioral sequelae\n* substance use disorder within the last 6 months (other than nicotine)\n* 4\\) endorsement of MRI exclusion factors",[63],"ADULT",[65],{"facility":12,"status":7,"city":66,"state":67,"zip":68,"country":69,"contacts":70,"geoPoint":83},"Athens","Georgia","30602","United States",[71,76,78,81],{"name":72,"role":73,"phone":74,"email":75},"Gregory P Strauss, PhD","CONTACT","706-542-0307","gstrauss@uga.edu",{"name":72,"role":77},"PRINCIPAL_INVESTIGATOR",{"name":79,"role":80},"Lawrence Sweet, PhD","SUB_INVESTIGATOR",{"name":82,"role":80},"Dean Sabatinelli, PhD",{"lat":84,"lon":85},33.96095,-83.37794,[87],{"name":72,"role":73,"phone":74,"email":75},[],[],[],{"nct_id":4,"conditions":92,"biomarkers":94},[93,18],"Schizoaffective Disorder",[],{"nct_id":4,"found":96,"summary":97,"prompt_version":106},true,{"design":98,"status":99,"heading":6,"summary":100,"follow_up":101,"word_count":102,"commitments":103,"compensation":104,"drugs_mentioned":105},"This interventional study plans to enroll 70 participants to compare two different behavioral training programs.","completed","This study is testing a cognitive training program to help people with psychotic disorders better manage their emotions. It compares two types of training: \"Emotional working memory training,\" which uses emotional tasks, and \"Placebo working memory training,\" which uses non-emotional tasks. Researchers want to see if the emotional training can improve how your brain's prefrontal cortex (the front part of your brain involved in decision-making and emotion) works, leading to better emotion regulation. You might be able to join if you are 18-60 years old, have been diagnosed with schizophrenia or schizoaffective disorder, speak English, and have been stable on your antipsychotic medication. The study aims to enroll 70 participants, but its current recruitment status is unclear.","The main goal is to measure changes in brain activity from the start of the study to 15 or 30 days later.",117,"Not specified in the trial record.","Not stated in the trial record.",[31,36],"v2"]