[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05617898":3,"trial-entities:NCT05617898":140,"trial-summary:NCT05617898":146},{"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":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":52,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":15,"eligibility_criteria":56,"std_ages":74,"locations":76,"central_contacts":134,"overall_officials":137,"references":138,"see_also_links":139},"NCT05617898","IRB-300009711","Determining the Role of Social Reward Learning in Social Anhedonia","Determining the Role of Social Reward Learning in Social Anhedonia in First-Episode Psychosis Using Motivational Interviewing in a Perturbation-Based Neuroimaging Approach","RECRUITING","2027-11","2026-07","2026-07-27","2023-06-14","University of Alabama at Birmingham","OTHER",false,"This is a clinical trial study that aims to evaluate the specificity of the relationship between reduced sensitivity to social reward and social anhedonia at both behavioral and neural levels. Individuals who recently experienced their first-episode psychosis will be recruited. Participants will be randomized 1:1 to motivational interviewing or a time- and format-matched control probe. At pre- and post-probe, participants will perform two social reward learning tasks in the scanner. With this design feature, we will examine the relationship between sensitivity to social reward and reduced subjective experience of social pleasure at both the behavioral and neural levels.",null,[19],"Psychosis",[21],"social anhedonia, social reward learning, fMRI, sensitivity to reward","INTERVENTIONAL","BASIC_SCIENCE",[25],"NA",{"count":27,"type":28},152,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","Motivational Interviewing","Three motivational interviewing sessions will target sensitivity to social reward, including subjective evaluation of social interaction, socially rewarding stimuli, and events (e.g., interactions with others, feedback from others).",[35],"Motivational Interview Intervention",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Nutrition Didactic Training","The Nutrition didactic training will ask participants to discuss pros and cons of healthy eating habits and how to improve their current eating habits.",[40],"Active Control Intervention",[42,46,49],{"measure":43,"description":44,"timeFrame":45},"Response Bias","Response bias is defined as the likelihood of making one response, such as the frequently rewarded stimulus, more than the other response during the perceptual social reward learning task","3 weeks",{"measure":47,"description":48,"timeFrame":45},"the number of optimal response","The number of optimal response is defined as the number of responses choosing a stimuli with optimal outcomes (e.g., choosing a good over a neutral machine or choosing a neutral over a bad machine) during the inductive social reward learning task.",{"measure":50,"description":51,"timeFrame":45},"fMRI activation levels","fMRI activation is defined as beta weights from general linear model from key regions of interests including the ventromedial prefrontal cortex, dorsal anterior cingulate cortex and ventral striatum during the perceptual social reward learning task and the inductive social reward learning task.",[],"ALL","18 Years","35 Years",{"inclusion":57,"exclusion":66,"raw_text":73},[58,59,60,61,62,63,64,65],"Age 18-35 years","A first episode of a psychotic illness that began within the past three years","Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder","Taking 2nd generation antipsychotic medications","Estimated premorbid IQ not less than 70 as assessed with the Wechsler Test of Adult Reading","Appropriate for scanning (i.e., no pacemaker or metal implants) and expressed willingness to participate in scanning","Sufficient fluency in English to comprehend testing procedures","Corrected vision of at least 20\u002F30",[67,68,69,70,71,72],"No evidence that substance use makes the diagnosis ambiguous (rule out substance-induced psychosis)","No evidence of moderate or severe alcohol or substance use disorder in the past 3 months","No clinically significant disease based on medical history (e.g., epilepsy) or significant head injury","For females: no current pregnancy","No sedatives or anxiolytics on the day of assessment","No medication change 3 weeks prior to enrollment","Inclusion Criteria:\n\n* Age 18-35 years\n* A first episode of a psychotic illness that began within the past three years\n* Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder\n* Taking 2nd generation antipsychotic medications\n* Estimated premorbid IQ not less than 70 as assessed with the Wechsler Test of Adult Reading\n* Appropriate for scanning (i.e., no pacemaker or metal implants) and expressed willingness to participate in scanning\n* Sufficient fluency in English to comprehend testing procedures\n* Corrected vision of at least 20\u002F30\n\nExclusion Criteria:\n\n* No evidence that substance use makes the diagnosis ambiguous (rule out substance-induced psychosis)\n* No evidence of moderate or severe alcohol or substance use disorder in the past 3 months\n* No clinically significant disease based on medical history (e.g., epilepsy) or significant head injury\n* For females: no current pregnancy\n* No sedatives or anxiolytics on the day of assessment\n* No medication change 3 weeks prior to enrollment",[75],"ADULT",[77,106],{"facility":13,"status":8,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":103},"Birmingham","Alabama","35294","United States",[83,88,92,94,97,99,101],{"name":84,"role":85,"phone":86,"email":87},"Andrew Meddaugh, BA","CONTACT","205-934-8203","ajmeddaugh@uabmc.edu",{"name":89,"role":85,"phone":90,"email":91},"Junghee Lee, PhD","205-934-8205","jungheelee@uabmc.edu",{"name":89,"role":93},"PRINCIPAL_INVESTIGATOR",{"name":95,"role":96},"Adrienne C Lahti, MD","SUB_INVESTIGATOR",{"name":98,"role":96},"Alison Thomas, PhD",{"name":100,"role":96},"Caitlin W Clevenger, PhD",{"name":102,"role":96},"Gerhard S Hellemann, PhD",{"lat":104,"lon":105},33.52066,-86.80249,{"facility":107,"status":8,"city":108,"state":109,"zip":110,"country":81,"contacts":111,"geoPoint":131},"University of California Los Angeles","Los Angeles","California","90095",[112,116,120,122,124,125,127,129],{"name":113,"role":85,"phone":114,"email":115},"Rebecca Zornitsky, MS","424-225-1779","zornitsky@mednet.ucla.edu",{"name":117,"role":85,"phone":118,"email":119},"Joseph Ventura, PhD","310-206-3142","jventura@mednet.ucla.edu",{"name":121,"role":93},"Keith H Nuechterlein, PhD",{"name":123,"role":93},"Michael F Green, PhD",{"name":117,"role":96},{"name":126,"role":96},"Kenneth Subotnik, PhD",{"name":128,"role":96},"Amy M Jimenez, PhD",{"name":130,"role":96},"Lena M Reddy, PhD",{"lat":132,"lon":133},34.05223,-118.24368,[135,136],{"name":89,"role":85,"phone":90,"email":91},{"name":84,"role":85,"phone":86,"email":87},[],[],[],{"nct_id":4,"conditions":141,"biomarkers":145},[19,142,143,144],"Schizoaffective Disorder","Schizophrenia","Schizophreniform Disorder",[],{"nct_id":4,"found":147,"summary":148,"prompt_version":158},true,{"design":149,"status":150,"heading":151,"summary":152,"follow_up":153,"word_count":154,"commitments":155,"compensation":156,"drugs_mentioned":157},"This study plans to enroll 152 participants and will randomly assign them to receive either Motivational Interviewing or Nutrition Didactic Training. Participants will be compared before and after their assigned intervention.","completed","Social Reward Learning in Psychosis Study","This study is looking at how people with a recent first episode of psychosis (a mental health condition that affects how you think, feel, and behave) respond to social rewards. Researchers want to understand the link between not feeling pleasure from social interactions (social anhedonia) and how the brain processes social rewards. You might be eligible if you are 18-35 years old, have had your first episode of psychosis within the last three years, have a diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder, and are taking second-generation antipsychotic medications. Participants will receive either Motivational Interviewing sessions, which focus on improving sensitivity to social rewards, or Nutrition Didactic Training. The study will measure your response bias, optimal responses, and brain activity using fMRI (functional magnetic resonance imaging) at 3 weeks. The current recruitment status is unclear.","Your response bias, optimal responses, and fMRI activation levels will be measured at 3 weeks.",135,"You will participate in three sessions of either Motivational Interviewing or Nutrition Didactic Training. Before and after these sessions, you will complete two social reward learning tasks while in an fMRI scanner.","Not stated in the trial record.",[32,37],"v2"]