[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535090":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":40,"locations":51,"responsibleParty":73,"collaborators":26,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":26,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":98,"overallStatus":54,"whyStopped":26,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Central Institute of Mental Health, Mannheim","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"real-time fMRI neurofeedback (of the ACC)","EXPERIMENTAL","Participants are instructed to reduce their stress-response by attempts to upregulate the ACC activity contigent on real-time feedback.",[13,14],"Behavioral: ScanSTRESS fMRI-paradigm (Streit et al., 2014)","Behavioral: real-time fMRI neurofeedback",{"label":16,"type":17,"description":18,"interventionNames":19},"Yoke-control group","SHAM_COMPARATOR","Participants receive previously recorded feedback signal from other participants\\' ACC activity instead of their own live ACC activity.",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","ScanSTRESS fMRI-paradigm (Streit et al., 2014)","The task is conducted within the MRI scanner and consists of two runs each lasting 11:20 mins., employs a block design and has two different conditions (performance, relaxation), as well as two different task within each condition. Participants undergo the following 2 tasks during the performance condition under time pressure: 1) serial subtraction, 2) a figure matching task. During the performance condition, all participants receive feedback (work faster, mistake, too slow) and are reprimanded concerning their performance. Two investigators in white coats observe the participants with critical facial expression, which is projected to participants through live-video feed during the tasks. The relaxation condition includes easy versions of arithmetic and figure matching task without time constrains or any type feedback on their performance. Performance and relaxation phases are appear in alternating order.",[16,9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"real-time fMRI neurofeedback","Two real-time fMRI neurofeedback sessions of 9:30 minutes each are conducted. During these sessions, the participants are instructed to regulate a feedback signal from the ACC. Participants are assigned to either the experimental or Yoke-control group through an automated double-blind procedure. In the neurofeedback sessions, participants in the experimental group receive a feedback signal indicating their current ACC activation. Participants in the control group receive the recorded feedback signal from another participant. The neurofeedback sessions follow a block structure with alternating feedback and rest periods.\n\nBefore, between, and after the two sections of the fMRI examination, subjective stress levels and alcohol craving are assessed, and saliva samples are collected for cortisol level determination.",[16,9],[32,36,38],{"name":33,"affiliation":34,"role":35},"Martin F Gerchen, PhD","Central Institute of Mental Health","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":34,"role":35},"Peter Kirsch, Prof., PhD",{"name":39,"affiliation":34,"role":35},"Falk Kiefer, MD, PhD",[41,47],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Nina J Kempf, M. Sc.","CONTACT","+ 49\u002F621-1703","6529","nina.kempf@zi-mannheim.de",{"name":48,"role":43,"phone":49,"phoneExt":45,"email":50},"Lea Wazulin, M. Sc.","+49-621\u002F1703","lea.wazulin@zi-mannheim.de",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Central Institute of Mental Health - Department of Clinical Psychology","RECRUITING","Mannheim","Baden-Wurttemberg","68159","Germany","DE",{"type":61,"coordinates":62},"Point",[63,64],8.46694,49.4891,{"lat":64,"lon":63},[67,70,72],{"name":33,"role":43,"phone":49,"phoneExt":68,"email":69},"6163","martin.gerchen@zi-mannheim.de",{"name":42,"role":71,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"name":48,"role":71,"phone":26,"phoneExt":26,"email":26},{"type":74,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100535090","using-neurofeedback-to-understand-the-relationship-between-stress-and-alcohol-consumption-100535090",false,"NCT06247306","Using Neurofeedback to Understand the Relationship Between Stress and Alcohol Consumption","Probing the Influence of Neural Stress Responses on Problematic Alcohol Use With Real-time fMRI Neurofeedback (C04)","NeuStress","Inclusion Criteria:\n\n* Age 18-65 years\n* Presence of 2 to a maximum of 5 criteria for alcohol use disorder according to DSM-5\n* no clinical necessity for detoxification treatment\n* participants may have a moderate cannabis use disorder and tobacco use disorder\n* Capacity for consent and ability to use self-assessment scales\n* Sufficient knowledge of German\n* Willingness to use a mobile phone with Android operating system\n\nExclusion Criteria:\n\n* Lifetime diagnosis of bipolar or psychotic disorder or a substance use disorder according to Diagnostical and Statistical Manual of Mental Disorders - 5 (DSM-5) that is not alcohol, cannabis, or tobacco use disorder\n* Current substance use other than cannabis and tobacco\n* Current diagnosis of one of the following conditions according to DSM-5: (hypo)manic episode, major depression, generalized anxiety disorder, post-traumatic stress disorder, borderline personality disorder, or obsessive-compulsive disorder\n* History of severe head trauma or other severe central neurological disorders (dementia, Parkinson\\'s disease, multiple sclerosis)\n* Pregnancy or lactation\n* Use of medications known to interact with the central nervous system within the last 10 days; testing at least four half-lives after the last dose\n* Exercising the prerogative of the \\"Right not to know\\" in the context of incidental findings during an examination or investigation","ALL","18 Years","65 Years",{"count":87,"type":88},102,"ESTIMATED","INTERVENTIONAL",[91],"NA","In this research project, the aim is to discover the role specific brain networks play in the relationship between stress reactions and the desire for alcohol and alcohol consumption. To investigate this question, various brain imaging methods as well as cognitive tasks are combined. Various questionnaires are sampled and brain scans are conducted.\n\nIndividuals interested in participating in the study have to fulfill certain criteria...\n\n* no serious medical or mental health diagnosis\n* problematic alcohol drinking habits\n* interested in improving drinking habits\n\n  ...and undergo various non-invasive procedures\n* filling out several questionnaires concerning personality and habits\n* undergoing a mental performance task while being in a brain scanner (MRI)\n* attempting to regulate their own brain activity while lying in the MRI scanner\n* filling out an electronic diary for 6 weeks - concerning daily mood, stress, and alcohol habits\n\nParticipants will be randomly allocated to either one of 2 experimental groups. Both groups undergo the same tasks, receive the same instructions and only differ regarding some aspects of the brain self-regulation task .",[94,95,96,97],"Alcohol Abuse","Craving","Psychosocial Stressor","Neural Stress Response",[99,100,101,102,103,104],"functional Magnetic Resonance Imaging (fMRI)","psychosocial stress","real-time fMRI neurofeedback (rtfMRI neurofeedback)","problematic alcohol use","cortisol","Ecological momentary assessment (EMA)","2025-01-22",{"date":107,"type":108},"2025-01-23","ACTUAL",{"date":110,"type":108},"2024-03-01",{"date":112,"type":88},"2027-07-01",{"name":5,"class":6},1]